Study of Vadadustat in Hemodialysis Participants With Ane... | NCT03799627 | Trialant
NCT03799627
Sponsor
Akebia Therapeutics
Status
Completed
Last Update Posted
Sep 29, 2022Actual
Enrollment
175Actual
Phase
Phase 2
Conditions
Anemia
Dialysis-dependent Chronic Kidney Disease
Interventions
Vadadustat
Epoetin Alfa
Vadadustat TIW
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03799627
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
AKB-6548-CI-0025
Secondary IDs
Not provided
Brief Title
Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa
Official Title
Phase 2, Randomized, Open-Label, Active-Controlled, Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Oral Vadadustat for the Treatment of Anemia in Hemodialysis Subjects Converting From Epoetin Alfa (FO2RWARD-2)
Acronym
FO2RWARD-2
Organization
Akebia TherapeuticsINDUSTRY
Status Module
Record Verification Date
Sep 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 31, 2019Actual
Primary Completion Date
Jun 5, 2020Actual
Completion Date
Jul 15, 2020Actual
First Submitted Date
Dec 3, 2018
First Submission Date that Met QC Criteria
Jan 8, 2019
First Posted Date
Jan 10, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Apr 27, 2022
Results First Submitted that Met QC Criteria
Sep 1, 2022
Results First Posted Date
Sep 29, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 4, 2021
Certification/Extension First Submitted that Passed QC Review
Sep 1, 2022
Certification/Extension First Posted Date
Sep 29, 2022Actual
Last Update Submitted Date
Sep 1, 2022
Last Update Posted Date
Sep 29, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Akebia TherapeuticsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a Phase 2 open-label efficacy, safety, and pharmacokinetic/pharmacodynamic (PK/PD) study to evaluate oral Vadadustat for the treatment of anemia in hemodialysis participants converting from Epoetin Alfa therapy.
Detailed Description
This is a Phase 2, randomized, open-label study to evaluate efficacy and safety of oral Vadadustat for the treatment of anemia in hemodialysis participants converting from Epoetin Alfa therapy. The study will be conducted in two parts running in parallel: Part 1, Main Study in a hemodialysis population on maintenance treatment with Epoetin Alfa; Part 2 is in a hemodialysis population that are erythropoiesis-stimulating agent (ESA) hyporesponders on maintenance treatment with Epoetin Alfa. For all participants (Main and ESA hyporesponder parallel study), the study will include a Screening Period, a Treatment Period, and a Safety Follow-Up Period. PK and PD sampling will be done throughout the study. The aim is to achieve and maintain hemoglobin (Hb) levels within the target range of 10.0 to 11.0 grams per deciliter (g/dL), inclusive, while targeting the middle of the range and minimizing excursions outside the target range.
Conditions Module
Conditions
Anemia
Dialysis-dependent Chronic Kidney Disease
Keywords
Vadadustat
AKB-6548
Anemia
Chronic kidney disease (CKD)
erythropoietin
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
175Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Vadadustat
Experimental
The initial dose of Vadadustat (300, 450, or 600 milligrams [mg]) will be based upon the dose of Epoetin Alfa dose participants had received prior to Vadadustat treatment
Drug: Vadadustat
Vadadustat TIW
Experimental
Participants randomized to Vadadustat (Main and erythropoiesis-stimulating agent [ESA] hyporesponder parallel studies) who complete a once-daily dosing regimen treatment period and meet eligibility criteria for transition to three times weekly (TIW) dosing will switch to TIW dosing
Drug: Vadadustat TIW
Epoetin Alfa
Active Comparator
Epoetin Alfa
Drug: Epoetin Alfa
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Vadadustat
Drug
Vadadustat Tablets 150 mg
Vadadustat
AKB-6548
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP)
Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1.
Baseline; Week 10 to Week 12
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported.
Up to Week 24
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values
Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes.
Up to Week 24
Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values
Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes.
Up to Week 24
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Hb Values Within the Target Range at the PEP
The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12.
Week 10 to Week 12
Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
≥18 years of age, providing informed consent
Receiving chronic, outpatient in-center hemodialysis (TIW) for end-stage renal disease for at least 12 weeks prior to Screening
Maintained on intravenous Epoetin Alfa therapy for 8 weeks prior to and including Screening through Screening Visit 2 (SV2)
Eligibility in the Main study and erythropoiesis-stimulating agent (ESA) hyporesponder parallel study is based on the following mean weekly Epoetin Alfa doses:
Main study: Mean weekly Epoetin Alfa dose <300 Units per kilogram per week (U/kg/week) for 8 weeks prior to SV2;
ESA hyporesponder parallel study: Mean weekly Epoetin Alfa dose ≥300 U/kg/week for 8 weeks prior to SV2
Two Hb values measured by the central laboratory at least 4 days apart between Screening Visit 1 (SV1) and SV2 as indicated:.
Main study: 2 Hb values between 8.5 and 11.0 g/dL, inclusive;
ESA hyporesponder parallel study: 2 Hb values between 8.0 and 10.0 grams per deciliter (g/dL), inclusive
Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening
Folate and vitamin B12 measurements ≥ lower limit of normal during Screening
Hemodialysis adequacy as indicated by single-pool Kt/Vurea ≥1.2 using the most recent historical measurement within 8 weeks prior to or during Screening
Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure
Exclusion Criteria:
Anemia due to a cause other than chronic kidney disease (e.g., sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia)
Active bleeding or recent blood loss within 8 weeks prior to randomization
Red blood cell (RBC) transfusion within 8 weeks prior to randomization
Anticipated to discontinue hemodialysis during the study
Judged by the Investigator that the participant is likely to need rescue therapy (ESA administration or RBC transfusion) immediately after enrollment in the study
History of chronic liver disease (e.g., chronic infectious hepatitis, chronic autoimmune liver disease, cirrhosis or fibrosis of the liver)
Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT), or total bilirubin >1.5 x upper limit of normal (ULN) during Screening. Participants with a history of Gilbert's syndrome are not excluded.
Current uncontrolled hypertension as determined by the Investigator that would contraindicate the use of Epoetin Alfa
Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for heart failure (HF) or New York Heart Association Class IV HF, or stroke within 12 weeks prior to or during Screening
History of new or recurrent malignancy within 2 years prior to and during Screening or currently receiving treatment or suppressive therapy for cancer. Participants with treated basal cell carcinoma of skin, curatively resected squamous cell carcinoma of skin, or cervical carcinoma in situ are not excluded.
History of deep vein thrombosis or pulmonary embolism within 12 weeks prior to or during Screening
History of hemosiderosis or hemochromatosis
History of prior organ transplantation (participants with a history of failed kidney transplant or corneal transplants are not excluded)
Scheduled organ transplant from a living donor and participants on the kidney transplant wait-list who are expected to receive a transplant within 6 months
History of a prior hematopoietic stem cell or bone marrow transplant (stem cell therapy for knee arthritis is not excluded)
Known hypersensitivity to Vadadustat, Epoetin Alfa, or any of their excipients
Any prior use of a hypoxia-inducible factor prolyl-hydroxylase (HIF-PH) inhibitor or any use of an investigational medication within 30 days or 5 half-lives of the investigational medication (whichever is longer), prior to randomization
For female participants of non-childbearing potential:
inability to confirm surgical sterility (e.g., hysterectomy, bilateral tubal ligation, bilateral oophorectomy) at least 1 month prior to Screening;
not considered post-menopausal (no menses for >1 year with follicle stimulating hormone >40 U/Liter at Screening)
For female participants of childbearing potential:
lack of confirmation of the use of acceptable forms of contraception* for a minimum of one complete menstrual cycle prior to Screening;
positive serum pregnancy test at SV2;
unwilling to use two acceptable forms of contraception* (at least one of which must be a barrier method) starting Baseline/Day 1, throughout the Treatment Period and for 30 days after the final study drug administration
Breastfeeding during Screening or throughout the Treatment Period and for 30 days after the final study drug administration
Donation of ova starting at Screening, throughout the Treatment Period, and for 30 days after the final study drug administration
Male participants who have not had a vasectomy and do not agree to the following: use of an acceptable form of contraception* during the study and for 30 days after the last dose of the study drug; to not donate semen during the study and for at least 30 days after the last dose of Vadadustat
Participants with bilateral native nephrectomy
Any other reason, which in the opinion of the Investigator, would make the participant not suitable for participation in the study
Acceptable forms of contraception include:
Established use of oral, injected or implanted hormonal methods of contraception;
Placement of an intrauterine device or intrauterine system;
Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
A total of 540 participants were screened, of which 175 participants were enrolled and randomized into the 2 parts of this study (Main Study; n=165; Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study: n=10). A total of 365 participants failed screening. Participants were randomized to either a Vadadustat or Epoetin Alfa treatment group, and randomization was stratified by mean weekly Epoetin Alfa dose calculated over a period of 8 weeks prior to Screening Visit 2.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Low Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jun 27, 2018
Apr 27, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized, Open-Label, Active-Controlled
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Epoetin Alfa
Drug
Epoetin Alfa
Epoetin Alfa
Procrit
Epogen
Vadadustat TIW
Drug
Oral Vadadustat
Vadadustat TIW
Number of Participants Classified as Hb Outliers
The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period.
Weeks 13 - 20
Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing.
Week 10 to Week 12; Week 18 to Week 20
Mean Change in Hb Between Baseline and the SEP
Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20.
Baseline; Week 18 to Week 20
Number of Participants With Hb Values Within the Target Range at the SEP
The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20.
Week 18 to Week 20
Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing
The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing.
Week 18 to Week 20
Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP
The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12.
Week 10 to Week 12
Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP
The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20.
Week 18 to Week 20
Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation
Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%.
Up to Week 20
Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue
ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL.
Up to Week 20
Number of Participants Requiring Red Blood Cell (RBC) Transfusion
RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood.
Up to Week 20
Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group
Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Mean Change From Baseline in Ferritin Concentration
Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Mean Change From Baseline in Total Iron Binding Capacity
Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Mean Change From Baseline in Hepcidin Concentration
Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline; Week 12 and Week 20
Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose
Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose.
Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose
Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose
Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose.
Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose
Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose
Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose.
Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose
Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose
Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose.
Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose
Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose
Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose.
Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose
Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose
Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose.
Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose
Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose
Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose.
Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose
Granada Hills
California
91344
United States
Research Site
Los Angeles
California
90022
United States
Research Site
Northridge
California
91324
United States
Research Site
Riverside
California
92501
United States
Research Site #1
San Dimas
California
91773
United States
Research Site #2
San Dimas
California
91773
United States
Research Site
San Gabriel
California
91776
United States
Research Site
Tarzana
California
91356
United States
Research Site
Vacaville
California
95688
United States
Research Site
Victorville
California
92394
United States
Research Site
Denver
Colorado
80230
United States
Research Site
Bridgeport
Connecticut
06606
United States
Research Site
Hartford
Connecticut
06762
United States
Research Site
Coral Gables
Florida
33134
United States
Research Site
Hollywood
Florida
33024
United States
Research Site
Miami
Florida
33126
United States
Research Site
Miami
Florida
33134
United States
Research Site
Miami
Florida
33150
United States
Research Site
Tampa
Florida
33607
United States
Research Site
Tampa
Florida
33614
United States
Research Site
Winter Park
Florida
32789
United States
Research Site
Augusta
Georgia
30909
United States
Research Site
Statesboro
Georgia
30458
United States
Research Site
Roseville
Michigan
48066
United States
Research Site #1
Minneapolis
Minnesota
55404
United States
Research Site #2
Minneapolis
Minnesota
55404
United States
Research Site
Kansas City
Missouri
64111
United States
Research Site
Las Vegas
Nevada
89107
United States
Research Site
The Bronx
New York
10461
United States
Research Site
Asheville
North Carolina
28801
United States
Research Site
Wilmington
North Carolina
28401
United States
Research Site
Canton
Ohio
44718
United States
Research Site
Oklahoma City
Oklahoma
73116
United States
Research Site
El Paso
Texas
79915
United States
Research Site
Houston
Texas
77004
United States
Research Site
San Antonio
Texas
78229
United States
Research Site
San Antonio
Texas
78258
United States
Research Site
Chesapeake
Virginia
23320
United States
Research Site
Norfolk
Virginia
23510
United States
Research Site
Wauwatosa
Wisconsin
53226
United States
FG001
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
FG002
Low Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
FG003
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
FG004
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
FG005
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
FG006
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
FG007
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
FG008
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
FG00035 subjects
FG00134 subjects
FG00223 subjects
FG00318 subjects
FG00421 subjects
FG00521 subjects
FG00613 subjects
FG0075 subjects
FG0085 subjects
COMPLETED
FG00027 subjects
FG00123 subjects
FG00222 subjects
FG0038 subjects
FG00412 subjects
FG0058 subjects
FG00610 subjects
FG0073 subjects
FG0082 subjects
NOT COMPLETED
FG0008 subjects
FG00111 subjects
FG0021 subjects
FG00310 subjects
FG0049 subjects
FG00513 subjects
FG0063 subjects
FG0072 subjects
FG0083 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0042 subjects
FG0055 subjects
FG0060 subjects
FG0072 subjects
FG0080 subjects
Physician Decision
FG0002 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
FG004
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Study Drug Put on Hold
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Due to Urgent Safety Measures Letter
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0032 subjects
FG004
Kidney Transplantation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Participant Was on Rescue Epogen
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Placed on Dose Hold Until End of Treatment
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Met Exclusion Criteria
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Investigational Product Noncompliance
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Participant Relocation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Eurofin Issue
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Noncompliance with Site Instructions
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Participant's Last Dose Prior to End of Treatment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Changes In Hemoglobin Values
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Low Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
BG001
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
BG002
Low Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
BG003
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
BG004
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
BG005
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
BG006
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
BG007
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
BG008
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00035
BG00134
BG00223
BG00318
BG00421
BG00521
BG00613
BG0075
BG0085
BG009175
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
<65 years
Title
Measurements
BG00020
BG00122
BG00215
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00014
BG00113
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP)
Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1.
Randomized Population: All randomized participants. Analysis of this population was based on the randomized treatment.
Posted
Mean
Standard Deviation
grams per deciliter (g/dL)
Baseline; Week 10 to Week 12
ID
Title
Description
OG000
Low Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
OG001
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG002
Low Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
OG003
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG005
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG006
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
OG007
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG008
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
Units
Counts
Participants
OG00035
OG00134
OG00223
OG003
Title
Denominators
Categories
Baseline
ParticipantsOG00035
ParticipantsOG00134
ParticipantsOG00223
ParticipantsOG003
Primary
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported.
Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
Posted
Count of Participants
Participants
Up to Week 24
ID
Title
Description
OG000
Low Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
Primary
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values
Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes.
Safety Population. Analysis of this population was based on the actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
Posted
Count of Participants
Participants
Up to Week 24
ID
Title
Description
OG000
Low Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
Primary
Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values
Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes.
Safety Population. Analysis of this population was based on the actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
Posted
Count of Participants
Participants
Up to Week 24
ID
Title
Description
OG000
Low Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
OG001
Primary
Number of Participants Classified as Hb Outliers
The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period.
Safety Population. Analysis of this population was based on the actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. Only participants with available data were included in the analysis. The rows presenting data for HB > 12.0 g/dL, HB > 13.0 g/dL and HB > 14.0 g/dL are mutually exclusive.
Posted
Count of Participants
Participants
Weeks 13 - 20
ID
Title
Description
OG000
Low Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
Secondary
Number of Participants With Hb Values Within the Target Range at the PEP
The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12.
Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.
Posted
Count of Participants
Participants
Week 10 to Week 12
ID
Title
Description
OG000
Low Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
OG001
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
Secondary
Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12
Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing.
Randomized Population. Analysis of this population was based on the randomized treatment. Only those who switched from Vadadustat QD to TIW dosing after Week 12 were included in the analysis (17 participants overall in Main Study and 0 participants in ESA Hyporesponder Parallel Study).
Posted
Mean
Standard Deviation
g/dL
Week 10 to Week 12; Week 18 to Week 20
ID
Title
Description
OG000
Vadadustat 300 mg (Starting Dose in TIW Dosing Regimen)
After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 300 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [150 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG001
Secondary
Mean Change in Hb Between Baseline and the SEP
Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20.
Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.
Posted
Mean
Standard Deviation
g/dL
Baseline; Week 18 to Week 20
ID
Title
Description
OG000
Low Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
OG001
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
Secondary
Number of Participants With Hb Values Within the Target Range at the SEP
The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20.
Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.
Posted
Count of Participants
Participants
Week 18 to Week 20
ID
Title
Description
OG000
Low Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
OG001
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
Secondary
Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing
The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing.
Randomized Population. Analysis of this population was based on the randomized treatment. Only those who switched from Vadadustat QD to TIW dosing after Week 12 were included in the analysis (17 participants overall in Main Study and 0 participants in ESA Hyporesponder Parallel Study).
Posted
Count of Participants
Participants
Week 18 to Week 20
ID
Title
Description
OG000
Vadadustat 300 mg (Starting Dose in TIW Dosing Regimen)
After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 300 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [150 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG001
Vadadustat 450 mg (Starting Dose in TIW Dosing Regimen)
Secondary
Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP
The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12.
Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.
Posted
Count of Participants
Participants
Week 10 to Week 12
ID
Title
Description
OG000
Low Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
OG001
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
Secondary
Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP
The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20.
Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
Secondary
Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation
Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%.
Randomized Population. Analysis of this population was based on the randomized treatment.
Posted
Count of Participants
Participants
Up to Week 20
ID
Title
Description
OG000
Low Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
OG001
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
Secondary
Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue
ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL.
Randomized Population. Analysis of this population was based on the randomized treatment.
Posted
Count of Participants
Participants
Up to Week 20
ID
Title
Description
OG000
Low Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
OG001
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
Secondary
Number of Participants Requiring Red Blood Cell (RBC) Transfusion
RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood.
Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.
Posted
Count of Participants
Participants
Up to Week 20
ID
Title
Description
OG000
Low Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
OG001
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
Secondary
Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group
Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Pharmacokinetic (PK) Population: all randomized participants who received study drug and had enough drug concentrations to estimate AUC and Cmax. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with concentrations below the limit of quantitation (BLQ) for all the time points were excluded from the analysis.
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
Secondary
Mean Change From Baseline in Reticulocyte Count
Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
OG001
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
Secondary
Mean Change From Baseline in Iron Concentration
Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
OG001
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Secondary
Mean Change From Baseline in Ferritin Concentration
Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
OG001
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Secondary
Mean Change From Baseline in Total Iron Binding Capacity
Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
OG001
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
Secondary
Mean Change From Baseline in Hepcidin Concentration
Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.
Posted
Mean
Standard Deviation
nanograms per milliliter (ng/mL)
Baseline; Week 12 and Week 20
ID
Title
Description
OG000
Low Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
OG001
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
Secondary
Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose
Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose.
PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Micrograms per milliliter (μg/mL)
Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose
ID
Title
Description
OG000
Low Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
Secondary
Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose
Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose.
PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours*µg/mL
Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose
ID
Title
Description
OG000
Low Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
Secondary
Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose
Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose.
PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.
Posted
Median
Full Range
Hours
Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose
ID
Title
Description
OG000
Low Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
OG001
Secondary
Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose
Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose.
PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.
Posted
Median
Full Range
Hours
Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose
ID
Title
Description
OG000
Low Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
OG001
Secondary
Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose
Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose.
PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
1/hour
Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose
ID
Title
Description
OG000
Low Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
Secondary
Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose
Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose.
PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
liters per hour
Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose
ID
Title
Description
OG000
Low Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
Secondary
Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose
Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose.
PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters
Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose
ID
Title
Description
OG000
Low Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
Time Frame
Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)
Description
TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Low Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.
0
34
9
34
11
34
EG001
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
0
35
7
35
20
35
EG002
Low Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
0
23
5
23
10
23
EG003
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
1
18
8
18
9
18
EG004
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
1
21
6
21
9
21
EG005
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
1
21
10
21
10
21
EG006
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
1
13
5
13
8
13
EG007
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
0
5
4
5
4
5
EG008
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
0
5
3
5
2
5
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG0030 events0 affected18 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected13 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
Nephrogenic anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Acute left ventricular failure
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected35 at risk
EG0022 events2 affected23 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0021 events1 affected23 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Incarcerated inguinal hernia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Incarcerated umbilical hernia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0021 events1 affected23 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Catheter site thrombosis
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0021 events1 affected23 at risk
EG003
Death
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Fatigue
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Liver injury
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Gangrene
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Localised infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected35 at risk
EG0021 events1 affected23 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected34 at risk
EG0010 events0 affected35 at risk
EG0021 events1 affected23 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0002 events1 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Arteriovenous fistula site complication
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Arteriovenous fistula thrombosis
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Arteriovenous graft thrombosis
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Vascular pseudoaneurysm
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Hypertensive encephalopathy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Seizure
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Subcapsular renal haematoma
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Nipple pain
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Uterine mass
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Acute pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Diabetic foot
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Pancreas transplant
Surgical and medical procedures
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Accelerated hypertension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected35 at risk
EG0021 events1 affected23 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Hypertensive urgency
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Hypotension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Subclavian artery stenosis
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG0031 events1 affected18 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
EG0060 events0 affected13 at risk
EG0071 events1 affected5 at risk
EG0080 events0 affected5 at risk
Nephrogenic anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Bundle branch block right
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Diastolic dysfunction
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Left atrial enlargement
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Mitral valve incompetence
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Right atrial enlargement
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Systolic dysfunction
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Cataract
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0012 events2 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0013 events3 affected35 at risk
EG0025 events4 affected23 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Asthenia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0013 events2 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Fatigue
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0013 events3 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Ulcer haemorrhage
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Acarodermatitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Localised infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Nail infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0013 events3 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0013 events3 affected35 at risk
EG0021 events1 affected23 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Arteriovenous fistula thrombosis
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected35 at risk
EG0021 events1 affected23 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected35 at risk
EG0022 events2 affected23 at risk
EG003
Graft thrombosis
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Vascular access complication
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Vascular pseudoaneurysm ruptured
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Weight decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0021 events1 affected23 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected35 at risk
EG0021 events1 affected23 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected34 at risk
EG0012 events2 affected35 at risk
EG0021 events1 affected23 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Syncope
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Costovertebral angle tenderness
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Uterine haemorrhage
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected34 at risk
EG0012 events2 affected35 at risk
EG0022 events2 affected23 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0021 events1 affected23 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Diabetic foot
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0012 events2 affected35 at risk
EG0021 events1 affected23 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Uraemic pruritus
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Haematoma
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0013 events3 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Hypovolaemic shock
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Shock haemorrhagic
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Vascular calcification
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected23 at risk
EG003
Conclusions were drawn from results of the Main Study (n=165). As the sample size in the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study (n=10) was small in both the Vadadustat and Epoetin Alfa treatment groups, these results did not allow to meaningful interpretation of the data.
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D052801
Male Urogenital Diseases
D002908
Chronic Disease
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000624313
vadadustat
D000068817
Epoetin Alfa
Ancestor Terms
ID
Term
D004921
Erythropoietin
D003115
Colony-Stimulating Factors
D006023
Glycoproteins
D006001
Glycoconjugates
D002241
Carbohydrates
D016298
Hematopoietic Cell Growth Factors
D016207
Cytokines
D036341
Intercellular Signaling Peptides and Proteins
D010455
Peptides
D000602
Amino Acids, Peptides, and Proteins
D011506
Proteins
D001685
Biological Factors
Browse Leaves
Not provided
Browse Branches
Not provided
2 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0081 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0081 subjects
FG004
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG004
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0052 subjects
FG0061 subjects
FG0070 subjects
FG0081 subjects
11
BG00418
BG00513
BG0067
BG0074
BG0083
BG009113
>=65 years
Title
Measurements
BG00015
BG00112
BG0028
BG0037
BG0043
BG0058
BG0066
BG0071
BG0082
BG00962
4
BG0037
BG0047
BG0059
BG0066
BG0074
BG0083
BG00967
Male
BG00021
BG00121
BG00219
BG00311
BG00414
BG00512
BG0067
BG0071
BG0082
BG009108
0
BG0032
BG0040
BG0051
BG0060
BG0070
BG0080
BG0094
Asian
BG0002
BG0011
BG0021
BG0031
BG0041
BG0051
BG0061
BG0070
BG0081
BG0099
Native Hawaiian or Other Pacific Islander
BG0001
BG0010
BG0021
BG0030
BG0040
BG0050
BG0060
BG0070
BG0082
BG0094
Black or African American
BG00018
BG00119
BG0027
BG0038
BG00413
BG00514
BG0066
BG0072
BG0082
BG00989
White
BG00010
BG0019
BG00213
BG0035
BG0046
BG0055
BG0065
BG0073
BG0080
BG00956
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Unknown or Not Reported
BG0004
BG0014
BG0021
BG0032
BG0041
BG0050
BG0061
BG0070
BG0080
BG00913
18
OG00421
OG00521
OG00613
OG0075
OG0085
18
ParticipantsOG00421
ParticipantsOG00521
ParticipantsOG00613
ParticipantsOG0075
ParticipantsOG0085
Title
Measurements
OG00010.223± 0.5805
OG00110.059± 0.6769
OG00210.165± 0.6806
OG0039.778± 0.6832
OG00410.288± 0.5445
OG00510.095± 0.7150
OG0069.950± 0.7950
OG0079.530± 0.2864
OG0089.620± 0.6925
Change from Baseline at PEP
ParticipantsOG00030
ParticipantsOG00130
ParticipantsOG00223
ParticipantsOG00312
ParticipantsOG00418
ParticipantsOG00514
ParticipantsOG00612
ParticipantsOG0074
ParticipantsOG0085
Title
Measurements
OG000-0.371± 0.8920
OG0010.072± 1.1353
OG0020.160± 0.7519
OG003
OG001
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG002
Low Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
OG003
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG005
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG006
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
OG007
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG008
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
Units
Counts
Participants
OG00034
OG00135
OG00223
OG00318
OG00421
OG00521
OG00613
OG0075
OG0085
Title
Denominators
Categories
Title
Measurements
OG00018
OG00127
OG00213
OG00312
OG00414
OG00513
OG0069
OG0075
OG0083
OG001
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG002
Low Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.
OG003
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG005
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG006
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
OG007
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG008
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
Units
Counts
Participants
OG00034
OG00135
OG00223
OG00318
OG00421
OG00521
OG00613
OG0075
OG0085
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG002
Low Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.
OG003
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG005
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG006
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
OG007
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG008
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
Units
Counts
Participants
OG00034
OG00135
OG00223
OG00318
OG00421
OG00521
OG00613
OG0075
OG0085
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG001
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG002
Low Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.
OG003
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG005
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG006
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
OG007
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG008
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
Units
Counts
Participants
OG00030
OG00127
OG00223
OG00310
OG00416
OG00513
OG00612
OG0073
OG0085
Title
Denominators
Categories
Hb >12.0 g/dL
Title
Measurements
OG0002
OG0012
OG0023
OG0030
OG0041
OG0050
OG0061
OG0070
OG0080
Hb >13.0 g/dL
Title
Measurements
OG0001
OG0010
OG0021
OG003
Hb >14.0 g/dL
Title
Measurements
OG0001
OG0010
OG0021
OG003
Hb <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline
Title
Measurements
OG0002
OG0012
OG0020
OG003
Hb increase >1.0 g/dL within any 2-week interval
Title
Measurements
OG0004
OG0018
OG0024
OG003
OG002
Low Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.
OG003
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG005
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG006
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
OG007
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG008
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
Units
Counts
Participants
OG00030
OG00130
OG00223
OG00312
OG00418
OG00514
OG00612
OG0074
OG0085
Title
Denominators
Categories
Title
Measurements
OG00012
OG00113
OG00215
OG0031
OG0044
OG0054
OG0066
OG0070
OG0080
Vadadustat 450 mg (Starting Dose in TIW Dosing Regimen)
After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 450 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [300 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG002
Vadadustat 600 mg (Starting Dose in TIW Dosing Regimen)
After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 600 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [450 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG003
Vadadustat 750 mg (Starting Dose in TIW Dosing Regimen)
After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 750 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [600 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
Vadadustat Total (TIW Dosing Regimen)
After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 1 tablet greater (150 mg) than final dose in QD dosing regimen. Vadadustat Total comprises all participants who switched from Vadadustat QD to TIW dosing regimen in the Main Study (i.e., combined arm for starting doses of 300mg, 450 mg, 600 mg and 750 mg). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat ≤ 750 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
Units
Counts
Participants
OG0001
OG0014
OG0027
OG0035
OG00417
OG0050
Title
Denominators
Categories
Title
Measurements
OG000-0.050± NAStandard deviation cannot be calculated due to only one participant with data
OG001-1.021± 1.0961
OG002-0.360± 0.4894
OG003-0.103± 1.9225
OG004-0.422± 1.1708
OG002
Low Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.
OG003
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG005
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG006
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
OG007
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG008
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
Units
Counts
Participants
OG00026
OG00124
OG00223
OG0037
OG00414
OG00510
OG00612
OG0073
OG0084
Title
Denominators
Categories
Title
Measurements
OG000-0.197± 1.1597
OG001-0.186± 0.8703
OG0020.070± 0.9545
OG0030.114± 1.0242
OG004-0.421± 0.8370
OG005-0.545± 0.9771
OG0060.343± 0.8897
OG007-0.283± 0.7371
OG008-0.400± 1.0157
OG002
Low Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.
OG003
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG005
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG006
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
OG007
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG008
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
Units
Counts
Participants
OG00026
OG00124
OG00223
OG0037
OG00414
OG00510
OG00612
OG0073
OG0084
Title
Denominators
Categories
Title
Measurements
OG0006
OG0017
OG0029
OG0032
OG0043
OG0052
OG0066
OG0071
OG0081
After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 450 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [300 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG002
Vadadustat 600 mg (Starting Dose in TIW Dosing Regimen)
After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 600 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [450 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG003
Vadadustat 750 mg (Starting Dose in TIW Dosing Regimen)
After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 750 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [600 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
Vadadustat Total (TIW Dosing Regimen)
After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 1 tablet greater (150 mg) than final dose in QD dosing regimen. Vadadustat Total comprises all participants who switched from Vadadustat QD to TIW dosing regimen in the Main Study (i.e., combined arm for starting doses of 300mg, 450 mg, 600 mg and 750 mg). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat ≤ 750 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
Units
Counts
Participants
OG0001
OG0014
OG0027
OG0035
OG00417
OG0050
Title
Denominators
Categories
Title
Measurements
OG0000
OG0012
OG0022
OG0033
OG0047
OG002
Low Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.
OG003
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG005
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG006
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
OG007
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG008
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.
OG003
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG005
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG006
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
OG007
ESA Hyporesponder (Epoetin Alfa ≥300 U/kg/Week): Vadadustat 600 mg
In the erythropoiesis-stimulating agent (ESA) hyporesponder parallel study participants who were maintained on ≥300 U/kg/week dose of Epoetin Alfa prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with an oral dose of Vadadustat 600 mg tablet per day.
OG008
ESA Hyporesponder (Epoetin Alfa ≥300 U/kg/Week): Epoetin Alfa
In the ESA hyporesponder parallel study participants who were maintained on ≥300 U/kg/week dose of Epoetin Alfa prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three TIW dose of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.
Units
Counts
Participants
OG00026
OG00124
OG00223
OG0037
OG00414
OG00510
OG00612
OG0073
OG0084
Title
Denominators
Categories
Title
Measurements
OG00010
OG00111
OG00214
OG0033
OG0045
OG0052
OG0068
OG0071
OG0082
OG002
Low Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.
OG003
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG005
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG006
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
OG007
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG008
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
Units
Counts
Participants
OG00035
OG00134
OG00223
OG00318
OG00421
OG00521
OG00613
OG0075
OG0085
Title
Denominators
Categories
Title
Measurements
OG00023
OG00121
OG00216
OG00310
OG00414
OG00518
OG00610
OG0074
OG0085
OG002
Low Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.
OG003
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG005
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG006
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
OG007
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG008
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
Units
Counts
Participants
OG00035
OG00134
OG00223
OG00318
OG00421
OG00521
OG00613
OG0075
OG0085
Title
Denominators
Categories
Title
Measurements
OG0002
OG0018
OG0023
OG0035
OG0045
OG0053
OG0061
OG0073
OG0081
OG002
Low Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.
OG003
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG005
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG006
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
OG007
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG008
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
Units
Counts
Participants
OG00035
OG00134
OG00223
OG00318
OG00421
OG00521
OG00613
OG0075
OG0085
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG0033
OG0041
OG0052
OG0060
OG0071
OG0081
OG001
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG002
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG003
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG005
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
Units
Counts
Participants
OG00033
OG00130
OG00215
OG00321
OG00415
OG0055
Title
Denominators
Categories
Baseline
ParticipantsOG00033
ParticipantsOG00130
ParticipantsOG00212
ParticipantsOG00317
ParticipantsOG00414
ParticipantsOG0055
Title
Measurements
OG0007.33± 57.3
OG0019.53± 54.0
OG0029.93± 83.6
OG003
Week 1
ParticipantsOG00033
ParticipantsOG00127
ParticipantsOG00215
ParticipantsOG00320
Week 1 +1 (Day 8)
ParticipantsOG00030
ParticipantsOG00127
ParticipantsOG00213
ParticipantsOG00321
Week 11
ParticipantsOG00012
ParticipantsOG00115
ParticipantsOG0024
ParticipantsOG0034
Week 13
ParticipantsOG0000
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0030
OG002
Low Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
OG003
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG005
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG006
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
OG007
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG008
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive
Units
Counts
Participants
OG00030
OG00132
OG00221
OG00318
OG00420
OG00521
OG00611
OG0075
OG0085
Title
Denominators
Categories
Baseline
ParticipantsOG00030
ParticipantsOG00132
ParticipantsOG00221
ParticipantsOG00318
ParticipantsOG00420
ParticipantsOG00521
ParticipantsOG00611
ParticipantsOG0075
ParticipantsOG0085
Title
Measurements
OG00051.9± 27.57
OG00147.2± 17.81
OG00248.8± 27.27
OG003
Week 1
ParticipantsOG00023
ParticipantsOG00121
ParticipantsOG00216
ParticipantsOG00311
Week 4
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00217
ParticipantsOG00315
Week 8
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00218
ParticipantsOG00312
Week 11
ParticipantsOG00021
ParticipantsOG00119
ParticipantsOG00217
ParticipantsOG0039
Week 12
ParticipantsOG00020
ParticipantsOG00121
ParticipantsOG00218
ParticipantsOG0037
Week 13
ParticipantsOG00022
ParticipantsOG00120
ParticipantsOG00217
ParticipantsOG0036
Week 16
ParticipantsOG00021
ParticipantsOG00121
ParticipantsOG00219
ParticipantsOG0035
Week 20
ParticipantsOG00020
ParticipantsOG00116
ParticipantsOG00219
ParticipantsOG0037
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG002
Low Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
OG003
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG005
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG006
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
OG007
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG008
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive
Units
Counts
Participants
OG00035
OG00134
OG00223
OG00318
OG00421
OG00521
OG00613
OG0075
OG0085
Title
Denominators
Categories
Baseline
ParticipantsOG00035
ParticipantsOG00134
ParticipantsOG00223
ParticipantsOG00318
ParticipantsOG00421
ParticipantsOG00521
ParticipantsOG00613
ParticipantsOG0075
ParticipantsOG0085
Title
Measurements
OG00087.4± 38.46
OG00193.9± 36.56
OG00290.1± 35.09
OG003
Week 4
ParticipantsOG00031
ParticipantsOG00129
ParticipantsOG00220
ParticipantsOG00316
Week 8
ParticipantsOG00031
ParticipantsOG00127
ParticipantsOG00221
ParticipantsOG00312
Week 12
ParticipantsOG00024
ParticipantsOG00125
ParticipantsOG00218
ParticipantsOG0038
Week 16
ParticipantsOG00026
ParticipantsOG00124
ParticipantsOG00221
ParticipantsOG0037
Week 20
ParticipantsOG00026
ParticipantsOG00123
ParticipantsOG00221
ParticipantsOG0037
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG002
Low Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
OG003
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG005
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG006
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
OG007
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG008
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive
Units
Counts
Participants
OG00034
OG00134
OG00223
OG00318
OG00421
OG00521
OG00613
OG0075
OG0085
Title
Denominators
Categories
Baseline
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00223
ParticipantsOG00318
ParticipantsOG00421
ParticipantsOG00521
ParticipantsOG00613
ParticipantsOG0075
ParticipantsOG0085
Title
Measurements
OG000939.3± 478.64
OG0011043.6± 359.10
OG002919.3± 298.27
OG003
Week 4
ParticipantsOG00031
ParticipantsOG00129
ParticipantsOG00220
ParticipantsOG00316
Week 8
ParticipantsOG00031
ParticipantsOG00126
ParticipantsOG00221
ParticipantsOG00312
Week 12
ParticipantsOG00024
ParticipantsOG00125
ParticipantsOG00217
ParticipantsOG0038
Week 16
ParticipantsOG00026
ParticipantsOG00124
ParticipantsOG00221
ParticipantsOG0037
Week 20
ParticipantsOG00026
ParticipantsOG00123
ParticipantsOG00221
ParticipantsOG0037
OG002
Low Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
OG003
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG005
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG006
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
OG007
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG008
ESA Hyporesponder: Epoetin Alfa
In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive
Units
Counts
Participants
OG00035
OG00134
OG00223
OG00318
OG00421
OG00521
OG00613
OG0075
OG0085
Title
Denominators
Categories
Baseline
ParticipantsOG00035
ParticipantsOG00134
ParticipantsOG00223
ParticipantsOG00318
ParticipantsOG00421
ParticipantsOG00521
ParticipantsOG00613
ParticipantsOG0075
ParticipantsOG0085
Title
Measurements
OG000237.8± 39.28
OG001230.7± 39.09
OG002234.8± 44.76
OG003
Week 4
ParticipantsOG00031
ParticipantsOG00129
ParticipantsOG00220
ParticipantsOG00316
Week 8
ParticipantsOG00031
ParticipantsOG00127
ParticipantsOG00221
ParticipantsOG00312
Week 12
ParticipantsOG00024
ParticipantsOG00125
ParticipantsOG00218
ParticipantsOG0038
Week 16
ParticipantsOG00026
ParticipantsOG00124
ParticipantsOG00221
ParticipantsOG0037
Week 20
ParticipantsOG00026
ParticipantsOG00123
ParticipantsOG00221
ParticipantsOG0037
OG002
Low Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
OG003
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG005
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG006
High Dose of Epoetin Alfa: Epoetin Alfa
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.
OG007
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG008
ESA Hyporesponder: Epoetin Alfa
In the ESA hyporesponder parallel study participants who were maintained on ≥300 U/kg/week dose of Epoetin Alfa prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three TIW dose of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.(US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive"
Units
Counts
Participants
OG00035
OG00134
OG00221
OG00317
OG00421
OG00521
OG00613
OG0075
OG0085
Title
Denominators
Categories
Baseline
ParticipantsOG00035
ParticipantsOG00134
ParticipantsOG00221
ParticipantsOG00317
ParticipantsOG00421
ParticipantsOG00521
ParticipantsOG00613
ParticipantsOG0075
ParticipantsOG0085
Title
Measurements
OG000194.870± 113.9348
OG001208.816± 85.1667
OG002259.161± 134.9995
OG003
Week 12
ParticipantsOG00024
ParticipantsOG00124
ParticipantsOG00217
ParticipantsOG0037
Week 20
ParticipantsOG00024
ParticipantsOG00123
ParticipantsOG00217
ParticipantsOG0036
OG001
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG002
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG003
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG005
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
Units
Counts
Participants
OG00032
OG00130
OG00214
OG00321
OG00417
OG0055
Title
Denominators
Categories
Week 1
ParticipantsOG00032
ParticipantsOG00130
ParticipantsOG00214
ParticipantsOG00321
ParticipantsOG00417
ParticipantsOG0055
Title
Measurements
OG00026.0± 87.9
OG00140.8± 54.8
OG00226.5± 59.3
OG003
Week 1 +1 (Day 8)
ParticipantsOG00030
ParticipantsOG00130
ParticipantsOG00214
ParticipantsOG00321
Week 11
ParticipantsOG00012
ParticipantsOG00115
ParticipantsOG0025
ParticipantsOG0034
Week 13
ParticipantsOG0000
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0030
OG001
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG002
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG003
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG005
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
Units
Counts
Participants
OG00029
OG00128
OG00213
OG00321
OG00413
OG0055
Title
Denominators
Categories
Week 1
ParticipantsOG00027
ParticipantsOG00123
ParticipantsOG00211
ParticipantsOG00319
ParticipantsOG00412
ParticipantsOG0055
Title
Measurements
OG000338± 63.8
OG001518± 71.1
OG002342± 81.7
OG003
Week 1 +1 (Day 8)
ParticipantsOG00029
ParticipantsOG00128
ParticipantsOG00213
ParticipantsOG00321
Week 11
ParticipantsOG00011
ParticipantsOG00114
ParticipantsOG0025
ParticipantsOG0034
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG002
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG003
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG005
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
Units
Counts
Participants
OG00017
OG00117
OG0028
OG0038
OG0046
OG0052
Title
Denominators
Categories
Week 1
ParticipantsOG00017
ParticipantsOG00117
ParticipantsOG0027
ParticipantsOG0038
ParticipantsOG0045
ParticipantsOG0052
Title
Measurements
OG0008.53(5.36 to 26.6)
OG00110.5(3.26 to 21.1)
OG00212.5(7.33 to 20.7)
OG003
Week 1 +1 (Day 8)
ParticipantsOG00013
ParticipantsOG00116
ParticipantsOG0028
ParticipantsOG0038
Week 11
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0022
ParticipantsOG0031
Week 13
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG002
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG003
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG005
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
Units
Counts
Participants
OG00032
OG00130
OG00214
OG00321
OG00417
OG0055
Title
Denominators
Categories
Week 1
ParticipantsOG00032
ParticipantsOG00130
ParticipantsOG00214
ParticipantsOG00321
ParticipantsOG00417
ParticipantsOG0055
Title
Measurements
OG0002.08(0.00 to 11.50)
OG0012.72(1.83 to 5.03)
OG0023.48(1.92 to 10.50)
OG003
Week 1 +1 (Day 8)
ParticipantsOG00030
ParticipantsOG00130
ParticipantsOG00214
ParticipantsOG00321
Week 11
ParticipantsOG00012
ParticipantsOG00115
ParticipantsOG0025
ParticipantsOG0034
Week 13
ParticipantsOG0000
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0030
OG001
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG002
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG003
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG005
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
Units
Counts
Participants
OG00017
OG00117
OG0028
OG0038
OG0046
OG0052
Title
Denominators
Categories
Week 1
ParticipantsOG00017
ParticipantsOG00117
ParticipantsOG0027
ParticipantsOG0038
ParticipantsOG0045
ParticipantsOG0052
Title
Measurements
OG0000.0797± 38.7
OG0010.0665± 50.5
OG0020.0560± 41.6
OG003
Week 1 +1 (Day 8)
ParticipantsOG00013
ParticipantsOG00116
ParticipantsOG0028
ParticipantsOG0038
Week 11
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0022
ParticipantsOG0031
Week 13
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
OG001
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG002
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG003
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG005
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
Units
Counts
Participants
OG00029
OG00128
OG00213
OG00321
OG00413
OG0055
Title
Denominators
Categories
Week 1
ParticipantsOG00027
ParticipantsOG00123
ParticipantsOG00211
ParticipantsOG00319
ParticipantsOG00412
ParticipantsOG0055
Title
Measurements
OG0000.888± 63.8
OG0010.869± 71.1
OG0020.877± 81.7
OG003
Week 1 +1 (Day 8)
ParticipantsOG00029
ParticipantsOG00128
ParticipantsOG00213
ParticipantsOG00321
Week 11
ParticipantsOG00011
ParticipantsOG00114
ParticipantsOG0025
ParticipantsOG0034
OG001
Low Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG002
High Dose of Epoetin Alfa: Vadadustat 300 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG003
High Dose of Epoetin Alfa: Vadadustat 450 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG004
High Dose of Epoetin Alfa: Vadadustat 600 mg
Participants who were maintained on the high dose of Epoetin Alfa (>90 to <300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
OG005
ESA Hyporesponder: Vadadustat 600 mg
In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.
Units
Counts
Participants
OG00016
OG00115
OG0028
OG0038
OG0046
OG0052
Title
Denominators
Categories
Week 1
ParticipantsOG00016
ParticipantsOG00113
ParticipantsOG0027
ParticipantsOG0038
ParticipantsOG0045
ParticipantsOG0052
Title
Measurements
OG00010.9± 36.2
OG00114.3± 53.4
OG00213.7± 69.7
OG003
Week 1 +1 (Day 8)
ParticipantsOG00013
ParticipantsOG00115
ParticipantsOG0028
ParticipantsOG0038
Week 11
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0022
ParticipantsOG0031
0 events
0 affected
18 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
18 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
18 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
18 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
18 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
18 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
18 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
18 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
18 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected21 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
18 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
18 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected13 at risk
EG0071 events1 affected5 at risk
EG0081 events1 affected5 at risk
0 events
0 affected
18 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
18 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
18 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
18 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
EG0061 events1 affected13 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
18 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
18 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
EG0062 events1 affected13 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
18 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
18 at risk
EG0041 events1 affected21 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
18 at risk
EG0041 events1 affected21 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
18 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
1 events
1 affected
18 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
18 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected5 at risk
1 events
1 affected
18 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
0 events
0 affected
18 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected5 at risk
1 events
1 affected
18 at risk
EG0041 events1 affected21 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected13 at risk
EG0070 events0 affected5 at risk
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-0.911
± 1.3515
OG004-0.284± 1.0383
OG005-0.418± 1.2752
OG0060.268± 1.0087
OG007-0.671± 0.7643
OG008-0.290± 1.7730
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0060
OG0070
OG0080
1
OG0041
OG0053
OG0061
OG0071
OG0081
4
OG0042
OG0053
OG0066
OG0070
OG0082
8.77
± 48.2
OG0046.98± 61.6
OG0058.03± 53.2
Participants
OG004
15
ParticipantsOG0055
Title
Measurements
OG00012.1± 94.3
OG00117.5± 97.0
OG00215.3± 72.6
OG00314.1± 86.4
OG00420.2± 90.8
OG00512.9± 54.2
ParticipantsOG00412
ParticipantsOG0055
Title
Measurements
OG00015.6± 76.3
OG00118.9± 98.2
OG00216.1± 76.0
OG00318.0± 49.8
OG00417.4± 104.8
OG0059.49± 37.1
Participants
OG004
8
ParticipantsOG0050
Title
Measurements
OG00014.2± 55.9
OG00114.9± 106.2
OG00219.4± 78.0
OG00320.6± 169.6
OG00417.3± 53.4
Participants
OG004
2
ParticipantsOG0050
Title
Measurements
OG00115.7± 107.2
OG00239.2± NADispersion data are not available for a single participant.
OG00410.5± 47.1
59.3
± 42.02
OG00448.4± 33.45
OG00551.5± 25.14
OG00662.6± 25.88
OG00777.6± 51.04
OG00883.0± 45.34
Participants
OG004
16
ParticipantsOG00516
ParticipantsOG00610
ParticipantsOG0075
ParticipantsOG0085
Title
Measurements
OG0003.1± 24.09
OG0016.9± 30.60
OG0021.0± 22.42
OG003-18.1± 24.81
OG004-3.9± 28.51
OG005-6.6± 33.80
OG00620.4± 48.64
OG007-35.8± 45.06
OG008-25.2± 29.73
Participants
OG004
19
ParticipantsOG00515
ParticipantsOG00611
ParticipantsOG0075
ParticipantsOG0085
Title
Measurements
OG00014.6± 32.25
OG00114.9± 29.45
OG0020.8± 40.68
OG003-5.6± 37.38
OG0042.9± 39.68
OG0056.1± 33.24
OG00622.5± 50.53
OG007-26.8± 55.44
OG00817.5± 26.21
Participants
OG004
14
ParticipantsOG00511
ParticipantsOG0068
ParticipantsOG0074
ParticipantsOG0085
Title
Measurements
OG00014.0± 31.40
OG00123.9± 39.26
OG00223.1± 38.98
OG0039.1± 46.38
OG00420.4± 49.42
OG00523.1± 20.33
OG00614.0± 54.60
OG007-3.3± 67.56
OG008-21.8± 69.36
Participants
OG004
15
ParticipantsOG0059
ParticipantsOG0069
ParticipantsOG0073
ParticipantsOG0085
Title
Measurements
OG00011.7± 25.06
OG00120.2± 25.80
OG00221.0± 35.12
OG00326.2± 26.2
OG00432.5± 70.42
OG0059.2± 41.30
OG0063.9± 46.15
OG007-6.7± 76.89
OG008-27.2± 71.36
Participants
OG004
14
ParticipantsOG00511
ParticipantsOG0069
ParticipantsOG0074
ParticipantsOG0084
Title
Measurements
OG00016.1± 32.60
OG00116.3± 34.27
OG00222.2± 26.72
OG00347.7± 66.66
OG00420.3± 44.30
OG00526.9± 52.64
OG0064.6± 39.53
OG0073.8± 52.72
OG008-17.3± 67.06
Participants
OG004
12
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0072
ParticipantsOG0083
Title
Measurements
OG00016.7± 27.07
OG00112.1± 43.12
OG00216.4± 26.53
OG00346.3± 57.25
OG00415.9± 43.79
OG00510.5± 28.80
OG0060.1± 46.05
OG0072.0± 83.44
OG00816.3± 11.93
Participants
OG004
9
ParticipantsOG00510
ParticipantsOG0067
ParticipantsOG0072
ParticipantsOG0084
Title
Measurements
OG00013.9± 35.40
OG00119.6± 37.61
OG0028.3± 34.16
OG003-2.2± 57.32
OG0049.7± 30.17
OG0050.2± 22.08
OG00626.6± 55.82
OG007-31.5± 86.97
OG0084.0± 16.21
Participants
OG004
12
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0073
ParticipantsOG0082
Title
Measurements
OG00014.5± 25.74
OG00113.2± 24.50
OG00223.8± 26.49
OG00310.3± 41.33
OG00416.4± 35.54
OG00510.9± 29.81
OG00638.5± 44.11
OG007-3.3± 52.58
OG00840.0± 7.07
57.7
± 26.71
OG00480.9± 36.94
OG00573.1± 22.23
OG00665.7± 23.93
OG00781.6± 37.01
OG00858.4± 18.77
Participants
OG004
20
ParticipantsOG00515
ParticipantsOG00613
ParticipantsOG0075
ParticipantsOG0084
Title
Measurements
OG000-8.0± 34.49
OG001-11.2± 33.59
OG002-18.3± 22.83
OG0033.3± 35.23
OG0049.6± 29.67
OG0051.7± 23.37
OG006-6.6± 32.86
OG0078.6± 17.36
OG0083.8± 25.79
Participants
OG004
17
ParticipantsOG00512
ParticipantsOG00611
ParticipantsOG0074
ParticipantsOG0085
Title
Measurements
OG000-5.5± 45.04
OG001-15.0± 40.51
OG002-8.6± 44.30
OG0034.5± 24.06
OG004-5.9± 36.91
OG00511.7± 40.33
OG006-12.6± 26.55
OG0070.3± 11.09
OG0082.0± 20.33
Participants
OG004
14
ParticipantsOG00510
ParticipantsOG0069
ParticipantsOG0074
ParticipantsOG0085
Title
Measurements
OG000-2.7± 38.24
OG001-22.2± 43.14
OG002-26.0± 33.03
OG003-2.8± 40.49
OG004-0.4± 40.20
OG005-5.1± 27.54
OG006-16.1± 22.88
OG007-2.5± 43.94
OG008-12.6± 28.99
Participants
OG004
10
ParticipantsOG00510
ParticipantsOG00610
ParticipantsOG0072
ParticipantsOG0084
Title
Measurements
OG000-22.8± 39.39
OG001-18.3± 39.85
OG002-17.9± 53.89
OG003-0.7± 10.26
OG0045.2± 30.27
OG005-4.6± 30.31
OG006-13.9± 44.05
OG00719.5± 53.03
OG008-12.0± 24.06
Participants
OG004
13
ParticipantsOG0058
ParticipantsOG00612
ParticipantsOG0073
ParticipantsOG0083
Title
Measurements
OG000-14.2± 41.11
OG001-9.5± 27.87
OG002-16.6± 46.49
OG00328.7± 67.73
OG004-3.1± 32.43
OG00513.4± 16.03
OG006-8.4± 28.94
OG007-15.3± 43.19
OG008-10.3± 21.57
910.2
± 408.03
OG004745.2± 362.98
OG005739.5± 329.66
OG006723.6± 484.29
OG0071182.2± 508.67
OG008449.6± 423.44
Participants
OG004
20
ParticipantsOG00515
ParticipantsOG00613
ParticipantsOG0075
ParticipantsOG0084
Title
Measurements
OG000-30.1± 185.45
OG001-101.9± 204.51
OG002-23.7± 274.39
OG00341.4± 335.00
OG004152.9± 347.97
OG00545.5± 320.50
OG006-145.6± 211.10
OG00734.8± 470.43
OG008-61.5± 17.37
Participants
OG004
17
ParticipantsOG00512
ParticipantsOG00611
ParticipantsOG0074
ParticipantsOG0085
Title
Measurements
OG000-120.8± 273.28
OG001-185.4± 298.19
OG00224.9± 334.28
OG00329.4± 361.29
OG004-5.6± 255.10
OG005-87.8± 285.30
OG006-78.3± 254.98
OG007111.3± 609.61
OG008397.8± 453.76
Participants
OG004
14
ParticipantsOG00510
ParticipantsOG0069
ParticipantsOG0074
ParticipantsOG0085
Title
Measurements
OG000-118.5± 220.40
OG001-194.8± 288.47
OG002-42.4± 356.19
OG003-68.0± 275.11
OG004-23.8± 303.39
OG005-30.1± 386.24
OG006-195.3± 304.63
OG007-0.5± 237.99
OG008-35.0± 157.46
Participants
OG004
10
ParticipantsOG00510
ParticipantsOG00610
ParticipantsOG0072
ParticipantsOG0084
Title
Measurements
OG000-92.0± 309.88
OG001-70.9± 288.34
OG00299.5± 567.19
OG003-144.0± 358.78
OG00427.8± 244.67
OG005-97.2± 188.15
OG006-81.8± 447.01
OG00780.0± 243.24
OG00862.3± 186.15
Participants
OG004
13
ParticipantsOG0058
ParticipantsOG00612
ParticipantsOG0073
ParticipantsOG0083
Title
Measurements
OG000-113.6± 327.06
OG001-166.6± 298.67
OG00226.5± 497.52
OG003-199.4± 370.32
OG0044.8± 331.76
OG005-51.6± 253.07
OG006-104.8± 347.53
OG007249.0± 636.33
OG008607.0± 607.0
210.1
± 33.33
OG004235.7± 38.80
OG005223.6± 34.31
OG006218.2± 33.80
OG007211.0± 42.99
OG008225.6± 98.15
Participants
OG004
20
ParticipantsOG00515
ParticipantsOG00613
ParticipantsOG0075
ParticipantsOG0084
Title
Measurements
OG00035.9± 27.11
OG00127.7± 33.58
OG002-13.4± 26.02
OG00327.6± 28.49
OG00441.0± 26.22
OG00548.2± 37.78
OG006-0.5± 21.44
OG00744.2± 53.58
OG0087.8± 14.38
Participants
OG004
17
ParticipantsOG00512
ParticipantsOG00611
ParticipantsOG0074
ParticipantsOG0085
Title
Measurements
OG00030.3± 28.42
OG00137.0± 40.99
OG002-1.1± 18.38
OG00326.3± 23.98
OG00449.4± 27.34
OG00558.8± 24.54
OG006-7.4± 19.26
OG00756.0± 58.15
OG008-24.8± 58.79
Participants
OG004
14
ParticipantsOG00510
ParticipantsOG0069
ParticipantsOG0074
ParticipantsOG0085
Title
Measurements
OG00042.4± 27.10
OG00137.2± 43.09
OG002-9.9± 25.85
OG00325.1± 33.90
OG00441.0± 39.05
OG00554.5± 44.05
OG006-3.8± 25.42
OG00758.0± 14.45
OG008-0.6± 15.32
Participants
OG004
10
ParticipantsOG00510
ParticipantsOG00610
ParticipantsOG0072
ParticipantsOG0084
Title
Measurements
OG00035.0± 43.00
OG00127.8± 35.16
OG002-3.0± 25.44
OG00355.3± 28.63
OG00453.1± 58.33
OG00560.9± 70.50
OG006-13.7± 31.46
OG00742.5± 62.93
OG008-2.5± 18.52
Participants
OG004
13
ParticipantsOG0058
ParticipantsOG00612
ParticipantsOG0073
ParticipantsOG0083
Title
Measurements
OG00038.0± 28.15
OG00144.9± 30.71
OG002-9.5± 29.29
OG00351.7± 37.50
OG00468.4± 43.40
OG00567.9± 58.44
OG006-5.4± 29.78
OG00766.7± 35.22
OG008-6.0± 21.79
185.852
± 105.6611
OG004215.608± 130.7350
OG005160.760± 102.6261
OG006143.519± 124.6749
OG007239.958± 151.3859
OG00874.748± 40.2119
Participants
OG004
14
ParticipantsOG00510
ParticipantsOG0069
ParticipantsOG0073
ParticipantsOG0085
Title
Measurements
OG000-50.565± 57.6474
OG001-53.675± 92.1185
OG002-66.646± 152.3178
OG003-55.283± 77.1648
OG004-34.868± 89.7176
OG005-74.797± 126.1667
OG006-62.787± 96.1842
OG007-128.587± 262.6300
OG008-1.062± 30.4842
Participants
OG004
13
ParticipantsOG0058
ParticipantsOG00610
ParticipantsOG0073
ParticipantsOG0083
Title
Measurements
OG000-86.025± 100.4382
OG001-38.627± 75.0555
OG002-83.685± 95.7049
OG003-93.412± 115.2839
OG004-83.012± 98.7521
OG005-43.701± 80.8411
OG006-80.680± 125.2481
OG007-152.243± 218.9284
OG008-9.023± 80.4001
47.0
± 38.2
OG00456.5± 39.2
OG00544.2± 73.1
ParticipantsOG00413
ParticipantsOG0055
Title
Measurements
OG00020.1± 174.4
OG00137.6± 78.9
OG00223.8± 69.0
OG00344.2± 29.6
OG00460.1± 41.6
OG00531.6± 151.6
Participants
OG004
8
ParticipantsOG0050
Title
Measurements
OG00028.6± 49.3
OG00124.4± 350.6
OG00232.4± 26.9
OG00338.1± 99.0
OG00441.2± 77.7
Participants
OG004
2
ParticipantsOG0050
Title
Measurements
OG00130.6± 102.7
OG00211.5± NADispersion data are not available for a single participant
OG00460.2± 9.2
605
± 54.5
OG004786± 36.6
OG005464± 80.9
ParticipantsOG00413
ParticipantsOG0055
Title
Measurements
OG000289± 76.6
OG001465± 80.8
OG002310± 94.7
OG003566± 41.1
OG004847± 54.8
OG005388± 112.4
Participants
OG004
8
ParticipantsOG0050
Title
Measurements
OG000344± 53.5
OG001338± 282.0
OG002402± 70.8
OG003450± 68.2
OG004588± 52.5
10.3
(6.33 to 18.3)
OG00411.0(6.51 to 18.0)
OG0059.01(8.45 to 9.58)
ParticipantsOG0046
ParticipantsOG0052
Title
Measurements
OG0008.82(5.80 to 22.9)
OG0018.83(4.98 to 70.0)
OG00210.1(4.79 to 17.9)
OG00312.4(5.73 to 47.8)
OG00414.6(5.61 to 31.3)
OG00511.7(11.3 to 12.0)
Participants
OG004
3
ParticipantsOG0050
Title
Measurements
OG0006.73(3.55 to 22.1)
OG00110.4(6.46 to 13.8)
OG0026.49(3.22 to 9.75)
OG0033.95(3.95 to 3.95)
OG0045.65(5.26 to 7.12)
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG00111.0(11.0 to 11.0)
OG0045.01(5.01 to 5.01)
3.50
(1.58 to 9.00)
OG0042.00(1.75 to 5.03)
OG0053.28(1.83 to 4.50)
ParticipantsOG00413
ParticipantsOG0055
Title
Measurements
OG0003.28(1.75 to 6.75)
OG0012.11(0.00 to 5.23)
OG0023.33(1.80 to 5.00)
OG0033.30(0.00 to 5.00)
OG0042.17(1.75 to 5.05)
OG0053.42(1.80 to 4.50)
Participants
OG004
8
ParticipantsOG0050
Title
Measurements
OG0003.23(0.00 to 4.50)
OG0013.50(1.75 to 10.83)
OG0023.50(2.00 to 4.67)
OG0032.03(1.75 to 3.63)
OG0042.11(1.80 to 5.00)
Participants
OG004
2
ParticipantsOG0050
Title
Measurements
OG0011.98(1.75 to 5.00)
OG0024.25(4.25 to 4.25)
OG0042.04(1.97 to 2.12)
0.0681
± 32.7
OG0040.0608± 46.9
OG0050.0771± 8.9
ParticipantsOG0046
ParticipantsOG0052
Title
Measurements
OG0000.0720± 44.2
OG0010.0615± 70.0
OG0020.0714± 53.9
OG0030.0469± 72.2
OG0040.0469± 74.4
OG0050.0594± 4.5
Participants
OG004
3
ParticipantsOG0050
Title
Measurements
OG0000.0925± 65.5
OG0010.0687± 26.5
OG0020.124± 92.0
OG0030.175± NADispersion data are not available for a single participant
OG0040.116± 15.9
Participants
OG004
1
ParticipantsOG0050
Title
Measurements
OG0010.0632± NADispersion data are not available for a single participant
OG0040.138± NADispersion data are not available for a single participant
0.744
± 54.5
OG0040.763± 36.6
OG0051.29± 80.9
ParticipantsOG00413
ParticipantsOG0055
Title
Measurements
OG0001.04± 76.6
OG0010.967± 80.8
OG0020.968± 94.7
OG0030.795± 41.1
OG0040.708± 54.8
OG0051.55± 112.4
Participants
OG004
8
ParticipantsOG0050
Title
Measurements
OG0000.872± 53.5
OG0011.33± 282.0
OG0020.747± 70.8
OG0031.00± 68.2
OG0041.02± 52.5
12.1
± 38.6
OG00413.8± 16.7
OG00515.8± 56.9
ParticipantsOG0046
ParticipantsOG0052
Title
Measurements
OG00012.5± 36.6
OG00113.7± 41.0
OG00217.4± 50.4
OG00315.3± 67.4
OG00415.6± 27.2
OG00512.4± 35.8
Participants
OG004
3
ParticipantsOG0050
Title
Measurements
OG00010.2± 28.7
OG00110.7± 37.6
OG00210.1± 10.3
OG0038.24± NADispersion data are not available for a single participant