Study of Roxadustat (FG-4592) in Participants With End-St... | NCT01147666 | Trialant
NCT01147666
Sponsor
Kyntra Bio
Status
Completed
Last Update Posted
Jan 11, 2022Actual
Enrollment
161Actual
Phase
Phase 2
Conditions
End Stage Renal Disease
Anemia
Interventions
Roxadustat
Epoetin Alfa
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT01147666
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
FGCL-4592-040
Secondary IDs
Not provided
Brief Title
Study of Roxadustat (FG-4592) in Participants With End-Stage Renal Disease Receiving Maintenance Hemodialysis
Official Title
A Phase 2, Randomized, Open-Label Active-Comparator (Epoetin Alfa) and Single-Blind Placebo-Controlled, Dose-Ranging Safety and Exploratory Efficacy Study of FG-4592 in Subjects With End-Stage Renal Disease Receiving Maintenance Hemodialysis
Acronym
Not provided
Organization
Kyntra BioINDUSTRY
Status Module
Record Verification Date
Dec 2021
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
May 17, 2010Actual
Primary Completion Date
Oct 15, 2012Actual
Completion Date
Oct 15, 2012Actual
First Submitted Date
May 20, 2010
First Submission Date that Met QC Criteria
Jun 18, 2010
First Posted Date
Jun 22, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 1, 2021
Results First Submitted that Met QC Criteria
Dec 14, 2021
Results First Posted Date
Jan 11, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 14, 2021
Last Update Posted Date
Jan 11, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Kyntra BioINDUSTRY
Collaborators
Name
Class
AstraZeneca
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
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
The primary objective of this study is to evaluate the efficacy and safety of roxadustat in participants with end-stage renal disease (ESRD) on maintenance hemodialysis (HD) therapy, previously treated with intravenous (IV) epoetin alfa.
Detailed Description
Dose ranging study with consecutive cohorts in two participant populations: participants normally responding to current anemia treatment (epoetin alfa) ("normoresponders": participants with baseline epoetin alfa dose at study entry 75 to 450 international units [IU]/kilograms [kg]/week) and participants not responding well to current treatment ("hyporesponders": participants with maintenance epoetin alfa dose above 450 IU/kg/week). Normoresponders are randomized to study drug roxadustat or epoetin alfa at a ratio of 3:1; hyporesponders are randomized to study drug roxadustat or epoetin alfa or placebo at a ratio of 2:1:1. The study objectives are to demonstrate that roxadustat is effective in maintaining hemoglobin (Hb) levels when converting from epoetin alfa and to establish optimum starting doses and dose adjustment regimens for Hb maintenance.
Conditions Module
Conditions
End Stage Renal Disease
Anemia
Keywords
Kidney
End Stage Renal Disease
ESRD
Chronic Kidney Disease
CKD
Renal
Anemia
Oral anemia treatment
Hemoglobin levels
Blood count
Erythropoietin
Hemodialysis
Normoresponder
Hyporesponder
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
161Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)
Experimental
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) will receive roxadustat capsules at a dose of 1.0 milligrams (mg)/kg, administered orally 3 times weekly (TIW) in the morning of the day after dialysis (interdialytic days) for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 grams [g]/deciliter [dL]) will be based upon regular monitoring of Hb.
Drug: Roxadustat
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)
Experimental
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) will receive roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb.
Drug: Roxadustat
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)
Experimental
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) will receive roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb.
Drug: Roxadustat
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
Experimental
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) will receive roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who have not completed 6-week treatment at the time of Amendment 2, will continue treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Roxadustat
Drug
Roxadustat will be administered per dose and schedule specified in the arms.
Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Normoresponder Participants Treated for 6 Weeks Only
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. Last observation carried forward (LOCF) method was used to impute missing values.
Week 7
Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Hyporesponsive Participants Treated for at Least 6 Weeks
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values.
Week 7
Number of Participants With a Mean Hb Above 11 g/dL When the Mean Hb Values at Weeks 17, 18, 19, and 20 Were Averaged, Among Participants Treated for 19 Weeks
The average of the mean Hb values that were above 11 g/dL at Weeks 17, 18, 19, and 20 are presented. LOCF method was used to impute missing values.
Weeks 17, 18, 19, and 20
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With a Mean of Hb Within 11-13 g/dL (Values Obtained at Weeks 17, 18, 19, and 20 for Participants Dosed for 19 Weeks)
The average of the mean Hb values that were within 11-13 g/dL at Weeks 17, 18, 19, and 20 are presented. LOCF method was used to impute missing values.
Weeks 17, 18, 19, and 20
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
ESRD and receiving maintenance HD TIW for ≥4 months prior to Day 1
Two most recent Hb values obtained during screening period must be within the ranges set below:
i) Group A. Normoresponder Criteria: Hb range in the 8 weeks prior to randomization within 9.0 to 13.5 g/dL ii) Group B. Hyporesponder Criteria: Hb range in the 8 weeks prior to randomization within 8.5 to 13.5 g/dL
Epoetin alfa, dose requirements:
i) Group A. Normoresponder Criteria - Cohorts A-1 to A-12: Stable IV epoetin alfa dose at baseline (that is, no more than a 30% fluctuation in the weekly dose) during the 4 weeks prior to study Day -3
Cohorts A-1 to A-4: Current and previous (past 4 weeks) epoetin alfa dose range 25 to 85 IU/kg/dose, TIW; weekly dose between 75 and 255 IU/kg/week
Cohort A-5: Current and previous (past 4 weeks) epoetin alfa dose range ≥85 to 115 IU/kg/dose, TIW; total weekly dose between 255 and 450 IU/kg/week
Cohort A-9: Current and previous (past 4 weeks) epoetin alfa dose range ≥85 to 150 IU/kg/dose, TIW; total weekly dose between 255 and 450 IU/kg/week
Cohorts A-6 to A-8: Current and previous (past 4 weeks) epoetin alfa dose range 25 to 115 IU/kg/dose, TIW, and two times a week (BIW); total weekly dose between 75 and 345 IU/kg/week
Cohorts A-10 to A-12: Optional cohorts to be decided (TBD), dosing frequency and dose range to be determined by sponsor ii) Group B. Hyporesponder Criteria:
Cohort B-1 (completed): Current and previous (past 4 weeks) epoetin alfa dose range 125 to 400 IU/kg/dose, TIW; weekly dose between 375 and 1200 IU/kg/week
Cohort B-2 to B-4: Current and previous (past 4 weeks) epoetin alfa dose range >115 IU/kg/dose, TIW; total weekly dose >345 IU/kg/week no requirement for stability of epoetin alfa doses
Complete Blood Count (CBC), Hematology, liver function blood tests, serum folate and vitamin B12 within acceptable limits
Absence of active or chronic gastrointestinal bleeding
High sensitivity C-reactive protein (hsCRP) <60 mg/liter for normoresponders Cohorts A-8 through A-12 enrolled under Amendment 3; no hsCRP criteria for hyporesponders
Body weight: 40 to 140 kg (dry weight)
Body mass index (BMI): 18 to 45 kg/meter square (m^2)
Dialysis vascular access via native arteriovenous fistula or synthetic graft, or permanent (tunneled) catheter (not via temporary catheter); permanent and temporary catheters, however, are still prohibited in Cohort A-5
Key Exclusion Criteria:
Anticipated change in HD prescription
Any clinically significant infection or evidence of an underlying infection
Positive for any of the following: Human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); or anti-hepatitis C virus antibody (anti-HCV Ab)
History of chronic liver disease
New York Heart Association Class III or IV congestive heart failure
Chronic inflammatory disease that could impact erythropoiesis (for example, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
History of myelodysplastic syndrome
History of hemosiderosis, hemochromatosis, polycystic kidney disease, or anephric
Active hemolysis or diagnosis of hemolytic syndrome
Known bone marrow fibrosis
Uncontrolled or symptomatic secondary hyperparathyroidism
Any prior organ transplantation
Drug-treated gastroparesis or short-bowel syndrome
History of alcohol or drug abuse; or a positive drug screen for a substance that has not been prescribed for the participant
Prior treatment with roxadustat
Diagnosis or suspicion of renal cell carcinoma
Red blood cell (RBC) transfusion within 12 weeks prior to Day 1, or anticipated need for RBC transfusion during the dosing period
IV iron supplement within 2 weeks prior to Day 1 and/or unwilling to withhold IV iron during the dosing/treatment period
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
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Normoresponder participants were enrolled sequentially in 10 cohorts (A-1 to A-10) with the exception of Cohort A-5 in parallel enrollment with A-6 to A-8. Hyporesponder participants were enrolled in 2 cohorts (B-1 and B-2). Normoresponder participants were those with stable baseline epoetin alfa doses between 75 and 450 international units (IU)/kilogram (kg)/week, while hyporeponders required maintenance epoetin alfa dose above 450 IU/kg/week.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.0 milligrams (mg)/kg, administered orally 3 times weekly (TIW) in the morning of the day after dialysis (interdialytic days) for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target hemoglobin (Hb) values (11.0-13.0 grams [g]/deciliter [dL]) was based upon regular monitoring of Hb.
Periods
Title
Milestones
Reasons Not Completed
Dosing Period 1: 6-Week Treatment
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: Roxadustat
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
Experimental
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) will receive roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb.
Drug: Roxadustat
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
Experimental
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) will receive roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) will receive tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants will receive roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) will receive tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants will receive roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb.
Drug: Roxadustat
Cohort A-9 (Roxadustat 2.0 mg/kg)
Experimental
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) will receive roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) will receive tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants will receive roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb.
Drug: Roxadustat
Cohorts A (Epoetin Alfa)
Active Comparator
Normoresponsive participants will receive IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing will occur on dialysis days in each Cohort A. Dose adjustment will be per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
Drug: Epoetin Alfa
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
Experimental
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) will receive roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb.
Drug: Roxadustat
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Experimental
Hyporesponsive participants (with baseline epoetin alfa dosage >115 IU/kg/dose at study entry) will receive roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who have not completed 6-week treatment at the time of Amendment 2, will continue treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) will be based upon regular monitoring of Hb.
Drug: Roxadustat
Cohort B (Epoetin Alfa)
Active Comparator
Hyporesponsive participants will receive IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing will occur on dialysis days in each Cohort B. Dose adjustment will be per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
Drug: Epoetin Alfa
Cohort B (Placebo)
Placebo Comparator
Hyporesponsive participants will receive placebo matched to roxadustat, administered orally TIW for 19 weeks.
Epoetin Alfa will be administered per dose and schedule specified in the arms.
Cohort B (Epoetin Alfa)
Cohorts A (Epoetin Alfa)
Placebo
Other
Placebo matching to roxadustat will be administered per schedule specified in the arm.
Cohort B (Placebo)
Number of Participants With a Mean of Hb Within 10-13 g/dL (Values Obtained at Weeks 17, 18, 19, and 20 for Participants Dosed for 19 Weeks)
The average of the mean Hb values that were within 10-13 g/dL at Weeks 17, 18, 19, and 20 are presented. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants. LOCF method was used to impute missing values.
Weeks 17, 18, 19, and 20
Change From Baseline in Hb at Week 7 for Participants Treated for at Least 6 Weeks
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values.
Baseline, Week 7
Change From Baseline in Hb at Weeks 8, 10, 12, 14, 17, 19, and 20 for Participants Treated for 7-19 Weeks
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values.
Baseline, Weeks 8, 10, 12, 14, 17, 19, and 20
Number of Participants Who Required Dose Adjustments During the Dosing Period for Participants Treated for 6 Weeks Only
Number of participants who required dose increase, dose reduce, dose interruption or dose resume were reported. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants.
Baseline up to Week 6
Number of Participants Who Required Dose Adjustments During the Dosing Period for Participants Treated for 19 Weeks
Number of participants who required dose increase, dose reduce, dose interruption or dose resume were reported. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants.
Baseline up to Week 19
Number of Participants Whose Hb Levels Were Maintained at Week 7 to Within ±1 g/dL of Their Mean 4-Week Screening Period Baseline Value for Participants Treated for At Least 6 Weeks
Week 7
Number of Participants Whose Hb Levels Were Maintained at Week 7 to Within ±1 g/dL of Their Mean 4-Week Screening Period Baseline Value for Participants Treated for 19 Weeks
Week 7
Number of Participants Treated for 6 Weeks Only Whose Hb Levels at Week 7 Were Greater Than Their Baseline Level
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants.
Week 7
Number of Participants Treated for 7-19 Weeks Whose Hb Levels at Weeks 8, 10, 12, 14, 17, 19, and 20 Were Greater Than Their Baseline Level
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants.
Weeks 8, 10, 12, 14, 17, 19, and 20
Number of Participants Who Required Rescue Anemia Treatment Due to Hb Levels, Among Participants Treated for at Least 6 Weeks
Rescue anemia treatment included any ESA dosing, RBC transfusion, or IV iron.
Baseline up to Week 6
Number of Participants Who Required Rescue Anemia Treatment Due to Hb Levels, Among Participants Treated for 19-Weeks
Rescue anemia treatment included any ESA dosing, RBC transfusion, or IV iron.
Baseline up to Week 19
Number of Participants Requiring Dose Reduction Secondary to Excessive Erythropoiesis During Dosing Period, Among Participants Treated for at Least 6-Weeks
Baseline up to Week 6
Number of Participants Requiring Dose Reduction Secondary to Excessive Erythropoiesis During Dosing Period, Among Participants Treated for 19-Weeks
Baseline up to Week 19
Rate of Change in Hb Levels, Measured by Regression Slopes of the Hb Values During Treatment up to Week 6
The rate of rise was computed as the slope of the regression line of change in Hb level (in g/dL) vs. time (in weeks) using Random Coefficient Model. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants.
Baseline up to Week 6
Trough Plasma Concentration of Roxadustat and Epoetin Alfa
Predose, 4, 8, 12, 24, 48, and 72 hours postdose at Weeks 1 and 6
Pine Bluff
Arkansas
United States
Azusa
California
United States
Los Angeles
California
United States
Northridge
California
United States
Ontario
California
United States
Paramount
California
United States
Yuba City
California
United States
Miami
Florida
United States
Pembroke Pines
Florida
United States
Honolulu
Hawaii
United States
Louisville
Kentucky
United States
Detroit
Michigan
United States
Kansas City
Missouri
United States
Paterson
New Jersey
United States
New York
New York
United States
Rosedale
New York
United States
Williamsville
New York
United States
Toledo
Ohio
United States
Orangeburg
South Carolina
United States
Arlington
Texas
United States
Fort Worth
Texas
United States
Houston
Texas
United States
San Antonio
Texas
United States
Fairfax
Virginia
United States
FG001
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
FG002
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
FG003
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
FG004
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
FG005
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
FG008
Cohort A-9 (Roxadustat 2.0 mg/kg)
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
FG010
Cohorts A (Epoetin Alfa)
Normoresponsive participants received intravenous (IV) epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
FG011
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
FG012
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage >115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
FG013
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
FG014
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
FG00012 subjects
FG00112 subjects
FG00212 subjects
FG00312 subjects
FG00412 subjects
FG00512 subjects
FG00612 subjects
FG00712 subjects
FG0082 subjects
FG00910 subjects
FG01036 subjects
FG0114 subjects
FG0125 subjects
FG0134 subjects
FG0144 subjects
Received at Least 1 Dose of Study Drug
FG00012 subjects
FG00112 subjects
FG00212 subjects
FG00312 subjects
FG00412 subjects
FG00512 subjects
FG00612 subjects
FG00712 subjects
FG0082 subjects
FG00910 subjects
FG01036 subjects
FG0114 subjects
FG0125 subjects
FG0134 subjects
FG0144 subjects
Efficacy Evaluable (EE) Population
Received study drug for at least 4 weeks with corresponding Hb measurements or permanently discontinued study medication during the dosing period due to lack of efficacy.
FG0009 subjects
FG00110 subjects
FG0029 subjects
FG00311 subjects
FG00411 subjects
FG00511 subjects
FG00611 subjects
FG00710 subjects
FG0082 subjects
FG00910 subjects
FG01031 subjects
FG0111 subjects
FG0123 subjects
FG0134 subjects
FG0143 subjects
COMPLETED
FG00010 subjects
FG00110 subjects
FG00211 subjects
FG00310 subjects
FG0047 subjects
FG0059 subjects
FG0069 subjects
FG0079 subjects
FG0082 subjects
FG0098 subjects
FG01033 subjects
FG0112 subjects
FG0121 subjects
FG0133 subjects
FG0140 subjects
NOT COMPLETED
FG0002 subjects
FG0012 subjects
FG0021 subjects
FG0032 subjects
FG0045 subjects
FG0053 subjects
FG0063 subjects
FG0073 subjects
FG0080 subjects
FG0092 subjects
FG0103 subjects
FG0112 subjects
FG0124 subjects
FG0131 subjects
FG0144 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
FG0140 subjects
Lack of Efficacy
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other than specified
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Non-compliance with study drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Dosing Period 2: 19-Week Treatment
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0037 subjects
FG00412 subjects
FG00512 subjects
FG00612 subjects
FG00712 subjects
FG0082 subjects
FG00910 subjects
FG01023 subjects
FG0110 subjects
FG0125 subjects
FG0133 subjects
FG0143 subjects
Received at Least 1 Dose of Study Drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0037 subjects
EE Population for 19-week Treatment
Participants randomized designated to receive 19 weeks of study medication and had received study drug for at least 4 weeks with corresponding Hb measurements or permanently discontinued study medication during the dosing period due to lack of efficacy.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0035 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Safety population included all participants who were randomized and received at least 1 dose of study medication.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.0 mg/kg, administered orally TIW in the morning of the day after dialysis (interdialytic days) for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
BG001
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
BG002
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
BG003
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
BG004
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
BG005
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
BG008
Cohort A-9 (Roxadustat 2.0 mg/kg)
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
BG010
Cohorts A (Epoetin Alfa)
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
BG011
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
BG012
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage >115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
BG013
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
BG014
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
BG015
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00012
BG00112
BG00212
BG00312
BG00412
BG00512
BG00612
BG00712
BG0082
BG00910
BG01036
BG0114
BG0125
BG0134
BG0144
BG015161
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00055.1± 12.1
BG00158.8± 13.6
BG00256.6± 10.8
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
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
Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Normoresponder Participants Treated for 6 Weeks Only
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. Last observation carried forward (LOCF) method was used to impute missing values.
EE population included participants who received treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (erythropoiesis-stimulating agent [ESA], IV Iron or red blood cell [RBC] transfusion) or who permanently discontinued study drug during dosing period due to lack of efficacy. Here, 'Overall number of participants analyzed' signifies normoresponder participants who were treated for 6 weeks only.
Posted
Count of Participants
Participants
Week 7
ID
Title
Description
OG000
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.0 mg/kg, administered orally TIW in the morning of the day after dialysis (interdialytic days) for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG001
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG002
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG003
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG004
Cohort A (Epoetin Alfa)
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
Units
Counts
Participants
OG0009
OG00110
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG0004
OG0018
OG0027
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Fisher Exact
1.0000
Threshold for significance at 0.05 level.
Other
OG001
OG004
Fisher Exact
0.0698
Primary
Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Hyporesponsive Participants Treated for at Least 6 Weeks
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values.
EE population included participants who received treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion) or who permanently discontinued study drug during dosing period due to lack of efficacy.
Posted
Count of Participants
Participants
Week 7
ID
Title
Description
OG000
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG001
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage >115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Primary
Number of Participants With a Mean Hb Above 11 g/dL When the Mean Hb Values at Weeks 17, 18, 19, and 20 Were Averaged, Among Participants Treated for 19 Weeks
The average of the mean Hb values that were above 11 g/dL at Weeks 17, 18, 19, and 20 are presented. LOCF method was used to impute missing values.
EE population for 19 weeks treatment included all participants randomized designated to receive 19 weeks of study medication and had received study treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion), or who permanently discontinued study medication during the dosing period due to lack of efficacy.
Posted
Count of Participants
Participants
Weeks 17, 18, 19, and 20
ID
Title
Description
OG000
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG001
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Secondary
Number of Participants With a Mean of Hb Within 11-13 g/dL (Values Obtained at Weeks 17, 18, 19, and 20 for Participants Dosed for 19 Weeks)
The average of the mean Hb values that were within 11-13 g/dL at Weeks 17, 18, 19, and 20 are presented. LOCF method was used to impute missing values.
EE population for 19 weeks treatment included all participants randomized designated to receive 19 weeks of study medication and had received study treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion), or who permanently discontinued study medication during the dosing period due to lack of efficacy.
Posted
Count of Participants
Participants
Weeks 17, 18, 19, and 20
ID
Title
Description
OG000
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG001
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Secondary
Number of Participants With a Mean of Hb Within 10-13 g/dL (Values Obtained at Weeks 17, 18, 19, and 20 for Participants Dosed for 19 Weeks)
The average of the mean Hb values that were within 10-13 g/dL at Weeks 17, 18, 19, and 20 are presented. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants. LOCF method was used to impute missing values.
EE population for 19 weeks treatment included all participants randomized designated to receive 19 weeks of study medication and had received study treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion), or who permanently discontinued study medication during the dosing period due to lack of efficacy.
Posted
Count of Participants
Participants
Weeks 17, 18, 19, and 20
ID
Title
Description
OG000
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG001
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
Secondary
Change From Baseline in Hb at Week 7 for Participants Treated for at Least 6 Weeks
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values.
EE population included participants who received treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion) or who permanently discontinued study drug during dosing period due to lack of efficacy.
Posted
Mean
Standard Deviation
g/dL
Baseline, Week 7
ID
Title
Description
OG000
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.0 mg/kg, administered orally TIW in the morning of the day after dialysis (interdialytic days) for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG001
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Secondary
Change From Baseline in Hb at Weeks 8, 10, 12, 14, 17, 19, and 20 for Participants Treated for 7-19 Weeks
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values.
EE population for 19 weeks treatment included all participants randomized designated to receive 19 weeks of study medication and had received study treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion), or who permanently discontinued study medication during the dosing period due to lack of efficacy.
Posted
Mean
Standard Deviation
g/dL
Baseline, Weeks 8, 10, 12, 14, 17, 19, and 20
ID
Title
Description
OG000
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG001
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Secondary
Number of Participants Who Required Dose Adjustments During the Dosing Period for Participants Treated for 6 Weeks Only
Number of participants who required dose increase, dose reduce, dose interruption or dose resume were reported. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants.
Safety population included all participants who were randomized and received at least one dose of study medication. Here, 'Overall number of participants analyzed' signifies participants who were treated for 6 weeks only.
Posted
Count of Participants
Participants
Baseline up to Week 6
ID
Title
Description
OG000
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.0 mg/kg, administered orally TIW in the morning of the day after dialysis (interdialytic days) for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG001
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Secondary
Number of Participants Who Required Dose Adjustments During the Dosing Period for Participants Treated for 19 Weeks
Number of participants who required dose increase, dose reduce, dose interruption or dose resume were reported. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants.
Safety population included all participants who were randomized and received at least one dose of study medication.
Posted
Count of Participants
Participants
Baseline up to Week 19
ID
Title
Description
OG000
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG001
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Secondary
Number of Participants Whose Hb Levels Were Maintained at Week 7 to Within ±1 g/dL of Their Mean 4-Week Screening Period Baseline Value for Participants Treated for At Least 6 Weeks
EE population included participants who received treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion) or who permanently discontinued study drug during dosing period due to lack of efficacy.
Posted
Count of Participants
Participants
Week 7
ID
Title
Description
OG000
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.0 mg/kg, administered orally TIW in the morning of the day after dialysis (interdialytic days) for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG001
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG002
Secondary
Number of Participants Whose Hb Levels Were Maintained at Week 7 to Within ±1 g/dL of Their Mean 4-Week Screening Period Baseline Value for Participants Treated for 19 Weeks
EE population for 19 weeks treatment included all participants randomized designated to receive 19 weeks of study medication and had received study treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion), or who permanently discontinued study medication during the dosing period due to lack of efficacy.
Posted
Count of Participants
Participants
Week 7
ID
Title
Description
OG000
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG001
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Secondary
Number of Participants Treated for 6 Weeks Only Whose Hb Levels at Week 7 Were Greater Than Their Baseline Level
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants.
EE population included participants who received treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion) or who permanently discontinued study drug during dosing period due to lack of efficacy. Here, 'Overall number of participants analyzed' signifies participants who were treated for 6 weeks only.
Posted
Count of Participants
Participants
Week 7
ID
Title
Description
OG000
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.0 mg/kg, administered orally TIW in the morning of the day after dialysis (interdialytic days) for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG001
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)
Secondary
Number of Participants Treated for 7-19 Weeks Whose Hb Levels at Weeks 8, 10, 12, 14, 17, 19, and 20 Were Greater Than Their Baseline Level
Baseline was defined as the mean of the last 3 Hb values obtained prior to the first dose of study treatment, including Day 1 predose. LOCF method was used to impute missing values. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants.
EE population for 19 weeks treatment included all participants randomized designated to receive 19 weeks of study medication and had received study treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion), or who permanently discontinued study medication during the dosing period due to lack of efficacy.
Posted
Count of Participants
Participants
Weeks 8, 10, 12, 14, 17, 19, and 20
ID
Title
Description
OG000
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG001
Secondary
Number of Participants Who Required Rescue Anemia Treatment Due to Hb Levels, Among Participants Treated for at Least 6 Weeks
Rescue anemia treatment included any ESA dosing, RBC transfusion, or IV iron.
Safety population included all participants who were randomized and received at least one dose of study medication.
Posted
Count of Participants
Participants
Baseline up to Week 6
ID
Title
Description
OG000
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.0 mg/kg, administered orally TIW in the morning of the day after dialysis (interdialytic days) for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG001
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG002
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)
Secondary
Number of Participants Who Required Rescue Anemia Treatment Due to Hb Levels, Among Participants Treated for 19-Weeks
Rescue anemia treatment included any ESA dosing, RBC transfusion, or IV iron.
Safety population included all participants who were randomized and received at least one dose of study medication.
Posted
Count of Participants
Participants
Baseline up to Week 19
ID
Title
Description
OG000
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG001
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG002
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
Secondary
Number of Participants Requiring Dose Reduction Secondary to Excessive Erythropoiesis During Dosing Period, Among Participants Treated for at Least 6-Weeks
Safety population included all participants who were randomized and received at least one dose of study medication.
Posted
Count of Participants
Participants
Baseline up to Week 6
ID
Title
Description
OG000
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.0 mg/kg, administered orally TIW in the morning of the day after dialysis (interdialytic days) for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG001
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG002
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Secondary
Number of Participants Requiring Dose Reduction Secondary to Excessive Erythropoiesis During Dosing Period, Among Participants Treated for 19-Weeks
Safety population included all participants who were randomized and received at least one dose of study medication.
Posted
Count of Participants
Participants
Baseline up to Week 19
ID
Title
Description
OG000
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG001
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG002
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
Secondary
Rate of Change in Hb Levels, Measured by Regression Slopes of the Hb Values During Treatment up to Week 6
The rate of rise was computed as the slope of the regression line of change in Hb level (in g/dL) vs. time (in weeks) using Random Coefficient Model. Because of the small number of hyporesponders enrolled into this study, data for this secondary efficacy analysis as planned per protocol was not collected and summarized for hyporesponder participants.
EE included participants who received treatment for at least 4 weeks with corresponding Hb measurements not resulted from any rescue therapies including inadvertent use of rescue medication (ESA, IV Iron or RBC transfusion) or who permanently discontinued study drug during dosing period due to lack of efficacy. Here, 'Overall number of participants analyzed' signifies participants who were treated for 6 weeks only.
Posted
Number
g/dL/week
Baseline up to Week 6
ID
Title
Description
OG000
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.0 mg/kg, administered orally TIW in the morning of the day after dialysis (interdialytic days) for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG001
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Secondary
Trough Plasma Concentration of Roxadustat and Epoetin Alfa
Data for trough plasma concentration of roxadustat and epoetin alfa were not collected for this study.
Posted
Predose, 4, 8, 12, 24, 48, and 72 hours postdose at Weeks 1 and 6
ID
Title
Description
OG000
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.0 mg/kg, administered orally TIW in the morning of the day after dialysis (interdialytic days) for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG001
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG002
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Time Frame
Baseline up to Week 23
Description
Safety population included all participants who were randomized and received at least one dose of study medication.
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
Cohort A-1 (Roxadustat 1.0 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.0 mg/kg, administered orally TIW in the morning of the day after dialysis (interdialytic days) for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
0
12
3
12
EG001
Cohort A-2 (Roxadustat 1.5 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
3
12
1
12
EG002
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
0
12
1
12
EG003
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
4
12
4
12
EG004
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
5
12
2
12
EG005
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
3
12
2
12
EG008
Cohort A-9 (Roxadustat 2.0 mg/kg)
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
3
10
3
10
EG010
Cohorts A (Epoetin Alfa)
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
6
36
2
36
EG011
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
2
4
3
4
EG012
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage >115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
2
5
2
5
EG013
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
1
4
0
4
EG014
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
0
4
1
4
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cellulitis
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG0040 affected12 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
EG0080 affected2 at risk
EG0090 affected10 at risk
EG0100 affected36 at risk
EG0111 affected4 at risk
EG0120 affected5 at risk
EG0130 affected4 at risk
EG0140 affected4 at risk
Gangrene
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Diabetic gangrene
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Endocarditis bacterial
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Infection
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Sepsis
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0012 affected12 at risk
EG0020 affected12 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Diverticular perforation
Gastrointestinal disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG003
Retroperitoneal haemorrhage
Gastrointestinal disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Arteriovenous fistula site haemorrhage
Injury, poisoning and procedural complications
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Vascular graft complication
Injury, poisoning and procedural complications
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Vascular pseudoaneurysm ruptured
Injury, poisoning and procedural complications
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Complex partial seizures
Nervous system disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Haemorrhagic stroke
Nervous system disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Chronic obstructive pulmonary
Respiratory, thoracic and mediastinal disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Sudden cardiac death
General disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Thyroid neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Major depression
Psychiatric disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Subcutaneous emphysema
Skin and subcutaneous tissue disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Peripheral vascular disorder
Vascular disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 10.1
Systematic Assessment
EG0001 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG0032 affected12 at risk
EG0042 affected12 at risk
EG0052 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
EG0080 affected2 at risk
EG0090 affected10 at risk
EG0102 affected36 at risk
EG0110 affected4 at risk
EG0120 affected5 at risk
EG0130 affected4 at risk
EG0140 affected4 at risk
Vomiting
Gastrointestinal disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 10.1
Systematic Assessment
EG0003 affected12 at risk
EG0010 affected12 at risk
EG0021 affected12 at risk
EG003
Fatigue
General disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Arteriovenous fistula site complication
Injury, poisoning and procedural complications
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Headache
Nervous system disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Syncope
Nervous system disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Catheter site pain
General disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Post procedural swelling
Injury, poisoning and procedural complications
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Otitis Externa
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Clinical Trial Information Desk
FibroGen, Inc.
415-978-1441
ID
Term
D007676
Kidney Failure, Chronic
D000740
Anemia
D051436
Renal Insufficiency, Chronic
Ancestor Terms
ID
Term
D051437
Renal Insufficiency
D007674
Kidney Diseases
D014570
Urologic Diseases
D052776
Female Urogenital Diseases
D005261
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
D006402
Hematologic Diseases
D006425
Hemic and Lymphatic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C584543
roxadustat
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
3 subjects
FG0051 subjects
FG0062 subjects
FG0072 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
FG0143 subjects
1 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
FG0140 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
1 subjects
FG0051 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
FG0131 subjects
FG0140 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0102 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0121 subjects
FG0130 subjects
FG0141 subjects
FG004
12 subjects
FG00512 subjects
FG00612 subjects
FG00712 subjects
FG0082 subjects
FG00910 subjects
FG01023 subjects
FG0110 subjects
FG0125 subjects
FG0133 subjects
FG0143 subjects
6 subjects
FG00411 subjects
FG00511 subjects
FG00611 subjects
FG00710 subjects
FG0082 subjects
FG00910 subjects
FG01022 subjects
FG0110 subjects
FG0123 subjects
FG0133 subjects
FG0142 subjects
7 subjects
FG0059 subjects
FG0069 subjects
FG0079 subjects
FG0082 subjects
FG0098 subjects
FG01021 subjects
FG0110 subjects
FG0121 subjects
FG0132 subjects
FG0140 subjects
5 subjects
FG0053 subjects
FG0063 subjects
FG0073 subjects
FG0080 subjects
FG0092 subjects
FG0102 subjects
FG0110 subjects
FG0124 subjects
FG0131 subjects
FG0143 subjects
0 subjects
FG0041 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
FG0140 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0043 subjects
FG0051 subjects
FG0062 subjects
FG0072 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
FG0142 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0131 subjects
FG0140 subjects
Other than specified
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0102 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
FG0140 subjects
Non-compliance with study drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
FG0141 subjects
50.8
± 19.4
BG00455.2± 10.6
BG00558.7± 10.1
BG00661.9± 11.9
BG00755.7± 14.5
BG00857.0± 17.0
BG00955.8± 6.8
BG01057.9± 11.0
BG01155.0± 8.8
BG01260.2± 5.9
BG01347.0± 12.5
BG01458.8± 8.6
BG01556.3± 3.680644
7
BG0035
BG0044
BG0052
BG0065
BG0074
BG0081
BG0093
BG01013
BG0113
BG0125
BG0132
BG0142
BG01561
Male
BG0008
BG00111
BG0025
BG0037
BG0048
BG00510
BG0067
BG0078
BG0081
BG0097
BG01023
BG0111
BG0120
BG0132
BG0142
BG015100
5
OG0049
4
OG0043
Threshold for significance at 0.05 level.
Other
OG002
OG004
Fisher Exact
0.1534
Threshold for significance at 0.05 level.
Other
OG003
OG004
Fisher Exact
0.2657
Threshold for significance at 0.05 level.
Other
OG002
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
OG003
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 6 weeks.
Units
Counts
Participants
OG0001
OG0013
OG0024
OG0033
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0022
OG0030
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG003
Fisher Exact
1.0000
Threshold for significance at 0.05 level.
Other
OG002
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG005
Cohort A-9 (Roxadustat 2.0 mg/kg)
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG007
Cohorts A (Epoetin Alfa)
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
OG008
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage >115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG009
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
OG010
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
Units
Counts
Participants
OG0006
OG00111
OG00211
OG00311
OG00410
OG0052
OG00610
OG00722
OG0083
OG0093
OG0102
Title
Denominators
Categories
Title
Measurements
OG0004
OG0014
OG0026
OG0035
OG0046
OG0052
OG0064
OG0078
OG0080
OG0090
OG0100
OG002
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG005
Cohort A-9 (Roxadustat 2.0 mg/kg)
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG007
Cohorts A (Epoetin Alfa)
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
OG008
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage >115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG009
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
OG010
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
Units
Counts
Participants
OG0006
OG00111
OG00211
OG00311
OG00410
OG0052
OG00610
OG00722
OG0083
OG0093
OG0102
Title
Denominators
Categories
Title
Measurements
OG0004
OG0011
OG0026
OG0035
OG0046
OG0052
OG0063
OG0078
OG0080
OG0090
OG0100
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG002
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG005
Cohort A-9 (Roxadustat 2.0 mg/kg)
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG007
Cohorts A (Epoetin Alfa)
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
Units
Counts
Participants
OG0006
OG00111
OG00211
OG00311
OG00410
OG0052
OG00610
OG00722
Title
Denominators
Categories
Title
Measurements
OG0005
OG0012
OG00210
OG00310
OG0047
OG0052
OG0066
OG00719
OG002
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG003
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG004
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG005
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG008
Cohort A-9 (Roxadustat 2.0 mg/kg)
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG010
Cohorts A (Epoetin Alfa)
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
OG011
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG012
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage >115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG013
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
OG014
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 6 weeks.
Units
Counts
Participants
OG0009
OG00110
OG0029
OG00311
OG00411
OG00511
OG00611
OG00710
OG0082
OG00910
OG01031
OG0111
OG0123
OG0134
OG0143
Title
Denominators
Categories
Title
Measurements
OG000-0.40± 1.56
OG0010.91± 1.59
OG0020.71± 1.61
OG0030.25± 1.86
OG004-0.15± 1.36
OG005-0.18± 1.55
OG006-0.32± 1.39
OG007-0.47± 0.94
OG008-0.00± 2.12
OG0090.24± 1.82
OG010-0.51± 1.31
OG011-2.63
OG012-0.89± 0.74
OG013-0.28± 0.81
OG014-2.50± 0.23
OG002
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG005
Cohort A-9 (Roxadustat 2.0 mg/kg)
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG007
Cohorts A (Epoetin Alfa)
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
OG008
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage >115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG009
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
OG010
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
Units
Counts
Participants
OG0006
OG00111
OG00211
OG00311
OG00410
OG0052
OG00610
OG00722
OG0083
OG0093
OG0102
Title
Denominators
Categories
Change at Week 8
Title
Measurements
OG0000.49± 1.31
OG0010.08± 1.56
OG0020.01± 1.51
OG003-0.49± 1.49
OG004-0.29± 1.09
OG0050.05± 2.05
OG0060.20± 1.85
OG007-0.21± 1.02
OG008-0.89± 0.99
OG009-0.41± 1.52
OG010-2.37± 0.00
Change at Week 10
Title
Measurements
OG0000.56± 1.49
OG0010.17± 1.65
OG002-0.17± 1.32
OG003
Change at Week 12
Title
Measurements
OG0000.26± 1.49
OG0010.04± 1.57
OG002-0.10± 1.42
OG003
Change at Week 14
Title
Measurements
OG0000.53± 1.55
OG001-0.03± 1.73
OG002-0.27± 1.29
OG003
Change at Week 17
Title
Measurements
OG000-0.09± 0.88
OG001-0.09± 1.96
OG002-0.27± 1.07
OG003
Change at Week 19
Title
Measurements
OG000-0.11± 1.18
OG001-0.32± 1.84
OG002-0.28± 1.07
OG003
Change at Week 20
Title
Measurements
OG000-0.39± 1.16
OG001-0.55± 1.88
OG002-0.55± 1.24
OG003
OG002
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG003
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG004
Cohort A (Epoetin Alfa)
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG0035
OG00413
Title
Denominators
Categories
Dose Increased
Title
Measurements
OG0000
OG0013
OG0020
OG0030
OG0049
Dose Reduced
Title
Measurements
OG0000
OG0010
OG0020
OG003
Dose Interrupted
Title
Measurements
OG0004
OG0017
OG0024
OG003
Dose Resume
Title
Measurements
OG0000
OG0016
OG0024
OG003
OG002
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG005
Cohort A-9 (Roxadustat 2.0 mg/kg)
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG007
Cohorts A (Epoetin Alfa)
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
Units
Counts
Participants
OG0007
OG00112
OG00212
OG00312
OG00412
OG0052
OG00610
OG00723
Title
Denominators
Categories
Dose Increased
Title
Measurements
OG0002
OG0015
OG0025
OG0034
OG0047
OG0051
OG0068
OG00712
Dose Reduced
Title
Measurements
OG0003
OG0013
OG0025
OG003
Dose Interrupted
Title
Measurements
OG0001
OG0015
OG0022
OG003
Dose Resume
Title
Measurements
OG0000
OG0013
OG0021
OG003
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG003
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG004
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG005
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG008
Cohort A-9 (Roxadustat 2.0 mg/kg)
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG010
Cohort A (Epoetin Alfa)
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
OG011
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG012
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage >115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG013
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
OG014
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 6 weeks.
Units
Counts
Participants
OG0009
OG00110
OG0029
OG00311
OG00411
OG00511
OG00611
OG00710
OG0082
OG00910
OG01031
OG0111
OG0123
OG0134
OG0143
Title
Denominators
Categories
Title
Measurements
OG0003
OG0013
OG0025
OG0035
OG0044
OG0053
OG0066
OG0076
OG0080
OG0091
OG01019
OG0110
OG0122
OG0133
OG0140
OG002
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG005
Cohort A-9 (Roxadustat 2.0 mg/kg)
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG007
Cohorts A (Epoetin Alfa)
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
OG008
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage >115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG009
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
OG010
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
Units
Counts
Participants
OG0006
OG00111
OG00211
OG00311
OG00410
OG0052
OG00610
OG00722
OG0083
OG0093
OG0102
Title
Denominators
Categories
Title
Measurements
OG0003
OG0014
OG0023
OG0036
OG0046
OG0050
OG0061
OG00713
OG0082
OG0093
OG0100
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG002
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG003
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG004
Cohort A (Epoetin Alfa)
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
Units
Counts
Participants
OG0009
OG00110
OG0029
OG0035
OG0049
Title
Denominators
Categories
Title
Measurements
OG0003
OG0017
OG0026
OG0033
OG0042
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG002
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-125 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-125 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-125 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG005
Cohort A-9 (Roxadustat 2.0 mg/kg)
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG007
Cohorts A (Epoetin Alfa)
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
Units
Counts
Participants
OG0006
OG00111
OG00211
OG00311
OG00410
OG0052
OG00610
OG00722
Title
Denominators
Categories
Week 8
Title
Measurements
OG0003
OG0016
OG0024
OG0034
OG0044
OG0051
OG0066
OG0079
Week 10
Title
Measurements
OG0003
OG0016
OG0024
OG003
Week 12
Title
Measurements
OG0003
OG0016
OG0026
OG003
Week 14
Title
Measurements
OG0003
OG0016
OG0026
OG003
Week 17
Title
Measurements
OG0002
OG0015
OG0025
OG003
Week 19
Title
Measurements
OG0002
OG0014
OG0025
OG003
Week 20
Title
Measurements
OG0003
OG0013
OG0025
OG003
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG003
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG004
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG005
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG008
Cohort A-9 (Roxadustat 2.0 mg/kg)
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG010
Cohort A (Epoetin Alfa)
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
OG011
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG012
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage >115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG013
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
OG014
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 6 weeks.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG00412
OG00512
OG00612
OG00712
OG0082
OG00910
OG01036
OG0114
OG0125
OG0134
OG0144
Title
Denominators
Categories
Title
Measurements
OG0002
OG0012
OG0023
OG0034
OG0042
OG0053
OG0062
OG0073
OG0080
OG0094
OG0106
OG0111
OG0123
OG0130
OG0141
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG005
Cohort A-9 (Roxadustat 2.0 mg/kg)
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG007
Cohorts A (Epoetin Alfa)
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
OG008
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage >115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG009
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
OG010
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
Units
Counts
Participants
OG0007
OG00112
OG00212
OG00312
OG00412
OG0052
OG00610
OG00723
OG0085
OG0093
OG0103
Title
Denominators
Categories
Title
Measurements
OG0004
OG0012
OG0023
OG0032
OG0043
OG0050
OG0064
OG0074
OG0083
OG0090
OG0101
OG003
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG004
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG005
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring o
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG008
Cohort A-9 (Roxadustat 2.0 mg/kg)
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG010
Cohort A (Epoetin Alfa)
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
OG011
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG012
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage >115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG013
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
OG014
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 6 weeks.
Units
Counts
Participants
OG00012
OG00112
OG00212
OG00312
OG00412
OG00512
OG00612
OG00712
OG0082
OG00910
OG01036
OG0114
OG0125
OG0134
OG0144
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0052
OG0061
OG0072
OG0081
OG0094
OG0106
OG0110
OG0120
OG0131
OG0140
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG005
Cohort A-9 (Roxadustat 2.0 mg/kg)
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG007
Cohorts A (Epoetin Alfa)
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
OG008
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage >115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG009
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
OG010
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.
Units
Counts
Participants
OG0007
OG00112
OG00212
OG00312
OG00412
OG0052
OG00610
OG00723
OG0085
OG0093
OG0103
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0022
OG0031
OG0042
OG0051
OG0064
OG0076
OG0080
OG0091
OG0100
OG002
Cohort A-3 (Roxadustat 2.0 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG003
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG004
Cohort A (Epoetin Alfa)
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
Units
Counts
Participants
OG0009
OG00110
OG0029
OG0035
OG0049
Title
Denominators
Categories
Title
Measurements
OG000-0.0135
OG0010.1926
OG0020.1682
OG003-0.0220
OG004-0.1267
OG003
Cohort A-4 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-85 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG004
Cohort A-5 (Roxadustat 1.8 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 85-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.8 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG005
Cohort A-6 (Roxadustat 1.3 mg/kg TIW)
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.3 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.3 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 100 mg, and 150 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG008
Cohort A-9 (Roxadustat 2.0 mg/kg)
Normoresponsive participants (with baseline epoetin alfa dosage 85-150 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
Normoresponsive participants (with baseline epoetin alfa dosage 25-115 IU/kg/dose at study entry) received tiered, weight-based initial doses of roxadustat (approximately 1.5 mg/kg/dose TIW). Low weight (40 to 60 kg), medium weight (>60 to 90 kg), and heavy weight (>90 to 140 kg) participants received roxadustat 70 mg, 120 mg, and 200 mg, respectively, administered as oral capsules for 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG010
Cohorts A (Epoetin Alfa)
Normoresponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort A. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
OG011
Cohort B-1 (Roxadustat 1.5 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage 125-400 IU/kg/dose at study entry) received roxadustat capsules at a dose of 1.5 mg/kg, administered orally TIW for 6 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG012
Cohort B-2 (Roxadustat 2.0 mg/kg TIW)
Hyporesponsive participants (with baseline epoetin alfa dosage >115 IU/kg/dose at study entry) received roxadustat capsules at a dose of 2.0 mg/kg, administered orally TIW for 6 weeks. Participants who had not completed 6-week treatment at the time of Amendment 2, continued treatment for up to 19 weeks. Dose adjustment to achieve correction and subsequent maintenance of target Hb values (11.0-13.0 g/dL) was based upon regular monitoring of Hb.
OG013
Cohort B (Epoetin Alfa)
Hyporesponsive participants received IV epoetin alfa treatments on Day 1, at their prestudy dose and according to their prestudy dosing schedule (TIW). Epoetin alfa dosing occurred on dialysis days in each Cohort B. Dose adjustment was per local standard of care (exclusive of IV iron) for routine maintenance of stable Hb levels on dialysis participants.
OG014
Cohort B (Placebo)
Hyporesponsive participants received placebo matched to roxadustat, administered orally TIW for 19 weeks.