Dose-Finding Study of Vadadustat in Japanese Subjects Wit... | NCT03054350 | Trialant
NCT03054350
Sponsor
Akebia Therapeutics
Status
Completed
Last Update Posted
Apr 8, 2021Actual
Enrollment
60Actual
Phase
Phase 2
Conditions
Anemia
Dialysis Dependent Chronic Kidney Disease
Interventions
Vadadustat
Placebo
Countries
Japan
Protocol Section
Identification Module
NCT ID
NCT03054350
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
AKB-6548-CI-0022
Secondary IDs
Not provided
Brief Title
Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
Official Title
Phase 2, Randomized, Double-Blind, Placebo Controlled, Dose-Finding Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
Acronym
Not provided
Organization
Akebia TherapeuticsINDUSTRY
Status Module
Record Verification Date
Mar 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
Dec 2016Actual
Primary Completion Date
Oct 24, 2017Actual
Completion Date
Jan 24, 2018Actual
First Submitted Date
Feb 13, 2017
First Submission Date that Met QC Criteria
Feb 13, 2017
First Posted Date
Feb 15, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Feb 2, 2021
Results First Submitted that Met QC Criteria
Mar 15, 2021
Results First Posted Date
Apr 8, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Nov 7, 2018
Certification/Extension First Submitted that Passed QC Review
Nov 7, 2018
Certification/Extension First Posted Date
Nov 9, 2018Actual
Last Update Submitted Date
Mar 15, 2021
Last Update Posted Date
Apr 8, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Akebia TherapeuticsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess the efficacy, safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of orally administered vadadustat in Japanese participants with anemia secondary to Dialysis-dependent Chronic Kidney Disease (DD-CKD).
Detailed Description
Not provided
Conditions Module
Conditions
Anemia
Dialysis Dependent Chronic Kidney Disease
Keywords
Anemia
kidney
dialysis dependent chronic kidney disease
CKD
DD
renal
vadadustat
AKB-6548
hypoxia-inducible factor
Akebia (AKB)
hypoxia-inducible factor (HIF)
HIF
prolyl-hydroxylase inhibitor (PHI)
PHI
Japan
Japanese
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
60Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Vadadustat, Dose 1
Experimental
Daily oral dose
Drug: Vadadustat
Vadadustat, Dose 2
Experimental
Daily oral dose
Drug: Vadadustat
Vadadustat, Dose 3
Experimental
Daily oral dose
Drug: Vadadustat
Placebo
Placebo Comparator
Daily oral dose
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Vadadustat
Drug
Daily oral dose
Vadadustat, Dose 1
Vadadustat, Dose 2
Vadadustat, Dose 3
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Mean Change in Hemoglobin (Hb) Levels From Pre-treatment to the End of the Primary Efficacy Period
The pre-treatment average value for Hb was defined as the average of 3 values obtained prior to treatment, i.e., the qualifying screening value and the Baseline value. Change from Pre-treatment was calculated as the Week 6 value minus the Pre-treatment value.
Pre-treatment; Week 6
Secondary Outcomes
Measure
Description
Time Frame
Time to Reach the Target Hb Level of 10.0 to 12.0 g/dL From Baseline up to Week 16
Time for this analysis was measured from Day 1 (Baseline) through the point in time during either the Primary Efficacy Period or the Dose Adjustment and Maintenance Period when a participant's Hb level achieved the target range of 10.0 to 12.0 g/dL.
from Baseline up to Week 16
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male and female Japanese participants ≥20 years of age
Receiving chronic maintenance hemodialysis for end-stage kidney disease
Hemoglobin (Hb) <10.0 grams per deciliter (g/dL)
Exclusion Criteria:
Anemia due to a cause other than chronic kidney disease (CKD) or presence of active bleeding or recent blood loss
Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia
Red blood cell transfusion within 4 weeks prior to or during screening
Anticipated to recover adequate kidney function to no longer require hemodialysis during study participation
Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Undecided
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Participants who had not recently received erythropoiesis-stimulating agent (ESA) therapy participated in 2 screening visits (SVs). Participants who had recently received ESA therapy and otherwise met the eligibility criteria were required to washout from ESA therapy prior to evaluation of screening hemoglobin levels and participate in 3 SVs.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Vadadustat 150 mg
Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target hemoglobin (Hb) of 10.0 to 12.0 grams/deciliter (g/dL) based on dose adjustment guidelines.
Periods
Title
Milestones
Reasons Not Completed
Primary Efficacy Period (6 Weeks)
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
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Feb 3, 2017
Jan 28, 2021
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
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderOutcomes Assessor
AKB-6548
Placebo
Drug
Daily oral dose
Placebo
Mean Hb Levels at the End of the Primary Efficacy Period
Data are reported as mean of the actual Week 6 values.
up to Week 6
Mean Hb Levels at the End of the Dose Adjustment and Maintenance Period
Data are reported as mean of the actual Week 16 values.
up to Week 16
Number of Participants Who Achieved the Target Hb Level of 10.0 to 12.0 g/dL at the End of the Dose Adjustment and Maintenance Period
up to Week 16
Mean Change in Hb Between Pre-treatment and the End of the Dose Adjustment and Maintenance Period
A pre-treatment average value for Hb was defined as the average of 3 values obtained prior to dosing, i.e., the 2 qualifying screening values and the Baseline value. Change from Pre-treatment was calculated as the Week 16 value minus the Pre-treatment value.
Pre-treatment; Week 16
Mean Change in Red Blood Cell (RBC) Count and Absolute Reticulocyte Count From Baseline to the End of the Primary Efficacy Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline; Week 6
Mean Change in RBC Count and Absolute Reticulocyte Count From Baseline to the End of the Dose Adjustment and Maintenance Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline; Week 16
Mean Change in Hematocrit and Reticulocytes From Baseline to the End of the Primary Efficacy Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline; Week 6
Mean Change in Hematocrit and Reticulocytes From Baseline to the End of the Dose Adjustment and Maintenance Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline; Week 16
Mean Change in Iron and Total Iron Binding Capacity (TIBC) From Baseline to the End of the Primary Efficacy Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline; Week 6
Mean Change in Iron and TIBC From Baseline to the End of the Dose Adjustment and Maintenance Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline; Week 16
Mean Change in Transferrin Saturation (TSAT) From Baseline to the End of the Primary Efficacy Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline; Week 6
Mean Change in TSAT From Baseline to the End of the Dose Adjustment and Maintenance Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline; Week 16
Mean Change in Ferritin and Hepcidin From Baseline to the End of the Primary Efficacy Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline; Week 6
Mean Change in Ferritin and Hepcidin From Baseline to the End of the Dose Adjustment and Maintenance Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline; Week 16
Number of Participants Who Required Rescue With a RBC Transfusion From Baseline to the End of the Primary Efficacy Period
Participants who initiated rescue therapy (including RBC transfusion) were required to stop study drug treatment and were discontinued from the study.
Baseline; Week 6
Number of Participants Who Required Rescue With RBC Transfusion From Baseline to the End of the Dose Adjustment and Maintenance Period
Participants who initiated rescue therapy (including RBC transfusion) were required to stop study drug treatment and were discontinued from the study.
Baseline; Week 16
Number of Participants Who Required Rescue With Erythropoiesis-Stimulating Agents (ESAs) From Baseline to the End of the Primary Efficacy Period
ESA rescue is defined as participants with ESA administration and 1) the participant experienced a clinically significant worsening of their anemia or symptoms of anemia, 2) the participant's Hb level is <9.0 g/dL, and 3) reason for early study withdrawal of worsening of anemia requiring ESA rescue or blood transfusion. Participants who initiated rescue therapy (including ESAs) were required to stop study drug treatment and were discontinued from the study.
Baseline; Week 6
Number of Participants Who Required Rescue With ESAs From Baseline to the End of the Dose Adjustment and Maintenance Period
ESA rescue is defined as participants with ESA administration and 1) the participant experienced a clinically significant worsening of their anemia or symptoms of anemia, 2) the participant's Hb level is <9.0 g/dL, and 3) reason for early study withdrawal of worsening of anemia requiring ESA rescue or blood transfusion. Participants who initiated rescue therapy (including ESAs) were required to stop study drug treatment and were discontinued from the study.
Baseline; Week 16
Number of the Participants With the Indicated Number of Dose Adjustments From Baseline to the End of the Dose Adjustment and Maintenance Period
Increases in dose were not allowed during the 6-week Primary Efficacy Period.
up to Week 16
Plasma Concentration Profile of Vadadustat and Its Metabolites Using a Pre-dose Sample From Week 4
Blood samples were collected for analysis.
Week 4, pre-dose
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs) in the Primary Efficacy Period
An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. An AE that met one or more of the following criteria or outcomes was classified as serious: death; life-threatening; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; was considered a medically important event not meeting the above criteria, but which could jeopardize a participant, or could require medical or surgical intervention to prevent one of the criteria listed in this definition.
up to Week 6
Number of Participants With TEAEs and Treatment-emergent SAEs in the Dose Adjustment and Maintenance Period
An AE was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. An AE that met one or more of the following criteria or outcomes was classified as serious: death; life-threatening; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; was considered a medically important event not meeting the above criteria, but which could jeopardize a participant, or could require medical or surgical intervention to prevent one of the criteria listed in this definition.
up to Week 16
Ehime
Japan
Fukui
Japan
Hiroshima
Japan
Hokkaido
Japan
Hyōgo
Japan
Ibaraki
Japan
Kagoshima
Japan
Kochi
Japan
Miyagi
Japan
Nagano
Japan
Nagasaki
Japan
Niigata
Japan
Okinawa
Japan
Osaka
Japan
Ōita
Japan
Saitama
Japan
Shizuoka
Japan
FG001
Vadadustat 300 mg
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
FG002
Vadadustat 600 mg
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
FG003
Placebo to Vadadustat 150 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 150 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
FG004
Placebo to Vadadustat 300 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 300 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
FG005
Placebo to Vadadustat 600 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 600 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
FG00015 subjects
FG00115 subjects
FG00215 subjects
FG0035 subjects
FG0045 subjects
FG0055 subjects
COMPLETED
FG00011 subjects
FG00113 subjects
FG00213 subjects
FG0033 subjects
FG0041 subjects
FG0052 subjects
NOT COMPLETED
FG0004 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0044 subjects
FG0053 subjects
Type
Comment
Reasons
ESA Rescue/Blood Transfusion for Anemia
FG0004 subjects
FG0012 subjects
FG0021 subjects
FG0032 subjects
FG0044 subjects
FG0053 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Dose Adjustment and Maintenance Period
Type
Comment
Milestone Data
STARTED
FG00011 subjects
FG00113 subjects
FG00213 subjects
FG0033 subjects
FG0041 subjects
FG0052 subjects
COMPLETED
FG00010 subjects
FG00113 subjects
FG00212 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
ESA Rescue/Blood Transfusion for Anemia
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline data are reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of study medication. The Safety Population was based on the actual treatment that participants received.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Vadadustat 150 mg
Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target hemoglobin (Hb) of 10.0 to 12.0 grams/deciliter (g/dL) based on dose adjustment guidelines.
BG001
Vadadustat 300 mg
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
BG002
Vadadustat 600 mg
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
BG003
Placebo to Vadadustat 150 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 150 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
BG004
Placebo to Vadadustat 300 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 300 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
BG005
Placebo to Vadadustat 600 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 600 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00015
BG00115
BG00215
BG0035
BG0045
BG0055
BG00660
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
ParticipantsBG00015
ParticipantsBG00115
ParticipantsBG00215
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00015
ParticipantsBG00115
ParticipantsBG002
Race and Ethnicity Not Collected
Race and Ethnicity were not collected from any participant.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG002
Hemoglobin Levels
Data are reported for members of the Modified Intent-to-Treat (mITT) Population, comprised of all randomized participants who received at least 1 dose of study medication, had a pre-treatment Hb average, and at least one post-Baseline Hb measurement. The mITT Population was based on the treatment to which participants were randomized.
Mean
Standard Deviation
grams per deciliter (g/dL)
Title
Denominators
Categories
ParticipantsBG00015
ParticipantsBG00115
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Mean Change in Hemoglobin (Hb) Levels From Pre-treatment to the End of the Primary Efficacy Period
The pre-treatment average value for Hb was defined as the average of 3 values obtained prior to treatment, i.e., the qualifying screening value and the Baseline value. Change from Pre-treatment was calculated as the Week 6 value minus the Pre-treatment value.
Modified Intent-to-Treat Population (mITT): all randomized participants who received at least 1 dose of study medication, had a pre-treatment Hb average, and at least one post-Baseline Hb measurement. The mITT Population was based on the treatment to which participants were randomized.
Posted
Least Squares Mean
Standard Error
grams per deciliter (g/dL)
Pre-treatment; Week 6
ID
Title
Description
OG000
Vadadustat 150 mg
Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.
OG001
Vadadustat 300 mg
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.
OG002
Vadadustat 600 mg
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.
OG003
Placebo
Participants were randomized to receive matching placebo for 6 weeks.
Units
Counts
Participants
OG00015
OG00115
OG00214
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.28± 0.218
OG0010.08± 0.222
OG0020.41± 0.233
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
OG003
ANCOVA
The analysis of covariance (ANCOVA) model includes treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.
0.0004
Least squares mean difference
1.19
Standard Error of the Mean
0.314
2-Sided
95
0.56
1.82
Superiority
OG001
OG003
Secondary
Time to Reach the Target Hb Level of 10.0 to 12.0 g/dL From Baseline up to Week 16
Time for this analysis was measured from Day 1 (Baseline) through the point in time during either the Primary Efficacy Period or the Dose Adjustment and Maintenance Period when a participant's Hb level achieved the target range of 10.0 to 12.0 g/dL.
mITT Population. Only participants with Hb < 10.0 g/dL at the Baseline visit were included in the analysis.
Posted
Mean
Standard Deviation
days
from Baseline up to Week 16
ID
Title
Description
OG000
Vadadustat 150 mg
Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target hemoglobin (Hb) of 10.0 to 12.0 grams/deciliter (g/dL) based on dose adjustment guidelines.
OG001
Vadadustat 300 mg
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG002
Vadadustat 600 mg
Secondary
Mean Hb Levels at the End of the Primary Efficacy Period
Data are reported as mean of the actual Week 6 values.
mITT Population. Only participants with available data were analyzed.
Posted
Mean
Standard Deviation
g/dL
up to Week 6
ID
Title
Description
OG000
Vadadustat 150 mg
Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet once daily QD, for 6 weeks.
OG001
Vadadustat 300 mg
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.
OG002
Vadadustat 600 mg
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.
OG003
Placebo
Participants were randomized to receive matching placebo for 6 weeks.
Secondary
Mean Hb Levels at the End of the Dose Adjustment and Maintenance Period
Data are reported as mean of the actual Week 16 values.
mITT Population. Only participants with available data were analyzed.
Posted
Mean
Standard Deviation
g/dL
up to Week 16
ID
Title
Description
OG000
Vadadustat 150 mg
Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet OD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG001
Vadadustat 300 mg
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets OD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG002
Vadadustat 600 mg
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets OD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
Secondary
Number of Participants Who Achieved the Target Hb Level of 10.0 to 12.0 g/dL at the End of the Dose Adjustment and Maintenance Period
mITT Population. Only participants with available data were analyzed.
Posted
Count of Participants
Participants
up to Week 16
ID
Title
Description
OG000
Vadadustat 150 mg
Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG001
Vadadustat 300 mg
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG002
Vadadustat 600 mg
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
Secondary
Mean Change in Hb Between Pre-treatment and the End of the Dose Adjustment and Maintenance Period
A pre-treatment average value for Hb was defined as the average of 3 values obtained prior to dosing, i.e., the 2 qualifying screening values and the Baseline value. Change from Pre-treatment was calculated as the Week 16 value minus the Pre-treatment value.
mITT Population. Only participants with available data were analyzed.
Posted
Mean
Standard Deviation
g/dL
Pre-treatment; Week 16
ID
Title
Description
OG000
Vadadustat 150 mg
Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG001
Vadadustat 300 mg
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG002
Vadadustat 600 mg
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
Secondary
Mean Change in Red Blood Cell (RBC) Count and Absolute Reticulocyte Count From Baseline to the End of the Primary Efficacy Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
mITT Population. Only participants with available data were analyzed.
Posted
Least Squares Mean
Standard Error
10^6 cells/microliter (µL)
Baseline; Week 6
ID
Title
Description
OG000
Vadadustat 150 mg
Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks.
OG001
Vadadustat 300 mg
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.
OG002
Vadadustat 600 mg
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.
OG003
Placebo
Participants were randomized to receive matching placebo for 6 weeks.
Secondary
Mean Change in RBC Count and Absolute Reticulocyte Count From Baseline to the End of the Dose Adjustment and Maintenance Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
mITT Population. Only participants with available data were analyzed.
Posted
Mean
Standard Deviation
10^6 cells/µL
Baseline; Week 16
ID
Title
Description
OG000
Vadadustat 150 mg
Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG001
Vadadustat 300 mg
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG002
Vadadustat 600 mg
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
Secondary
Mean Change in Hematocrit and Reticulocytes From Baseline to the End of the Primary Efficacy Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
mITT Population. Only participants with available data were analyzed.
Posted
Least Squares Mean
Standard Error
percentage
Baseline; Week 6
ID
Title
Description
OG000
Vadadustat 150 mg
Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks.
OG001
Vadadustat 300 mg
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.
OG002
Vadadustat 600 mg
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.
OG003
Placebo
Participants were randomized to receive matching placebo for 6 weeks.
Secondary
Mean Change in Hematocrit and Reticulocytes From Baseline to the End of the Dose Adjustment and Maintenance Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
mITT Population. Only participants with available data were analyzed.
Posted
Mean
Standard Deviation
percentage
Baseline; Week 16
ID
Title
Description
OG000
Vadadustat 150 mg
Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG001
Vadadustat 300 mg
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG002
Vadadustat 600 mg
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
Secondary
Mean Change in Iron and Total Iron Binding Capacity (TIBC) From Baseline to the End of the Primary Efficacy Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
mITT Population. Only participants with available data were analyzed.
Posted
Mean
Standard Deviation
micrograms per deciliter (μg/dL)
Baseline; Week 6
ID
Title
Description
OG000
Vadadustat 150 mg
Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks.
OG001
Vadadustat 300 mg
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.
OG002
Vadadustat 600 mg
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.
OG003
Placebo
Participants were randomized to receive matching placebo for 6 weeks.
Secondary
Mean Change in Iron and TIBC From Baseline to the End of the Dose Adjustment and Maintenance Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
mITT Population. Only participants with available data were analyzed.
Posted
Mean
Standard Deviation
μg/dL
Baseline; Week 16
ID
Title
Description
OG000
Vadadustat 150 mg
Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG001
Vadadustat 300 mg
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG002
Vadadustat 600 mg
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
Secondary
Mean Change in Transferrin Saturation (TSAT) From Baseline to the End of the Primary Efficacy Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
mITT Population. Only participants with available data were analyzed.
Posted
Mean
Standard Deviation
percentage
Baseline; Week 6
ID
Title
Description
OG000
Vadadustat 150 mg
Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks.
OG001
Vadadustat 300 mg
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.
OG002
Vadadustat 600 mg
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.
OG003
Placebo
Participants were randomized to receive matching placebo for 6 weeks.
Secondary
Mean Change in TSAT From Baseline to the End of the Dose Adjustment and Maintenance Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
mITT Population. Only participants with available data were analyzed.
Posted
Mean
Standard Deviation
percentage
Baseline; Week 16
ID
Title
Description
OG000
Vadadustat 150 mg
Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG001
Vadadustat 300 mg
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG002
Vadadustat 600 mg
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
Secondary
Mean Change in Ferritin and Hepcidin From Baseline to the End of the Primary Efficacy Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
mITT Population. Only participants with available data were analyzed.
Posted
Mean
Standard Deviation
nanograms per milliliter (ng/mL)
Baseline; Week 6
ID
Title
Description
OG000
Vadadustat 150 mg
Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks.
OG001
Vadadustat 300 mg
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.
OG002
Vadadustat 600 mg
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.
OG003
Placebo
Participants were randomized to receive matching placebo for 6 weeks.
Secondary
Mean Change in Ferritin and Hepcidin From Baseline to the End of the Dose Adjustment and Maintenance Period
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
mITT Population. Only participants with available data were analyzed.
Posted
Mean
Standard Deviation
ng/mL
Baseline; Week 16
ID
Title
Description
OG000
Vadadustat 150 mg
Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG001
Vadadustat 300 mg
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG002
Vadadustat 600 mg
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
Secondary
Number of Participants Who Required Rescue With a RBC Transfusion From Baseline to the End of the Primary Efficacy Period
Participants who initiated rescue therapy (including RBC transfusion) were required to stop study drug treatment and were discontinued from the study.
mITT Population. Only participants with available data were analyzed.
Posted
Count of Participants
Participants
Baseline; Week 6
ID
Title
Description
OG000
Vadadustat 150 mg
Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks.
OG001
Vadadustat 300 mg
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.
OG002
Vadadustat 600 mg
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.
OG003
Placebo
Participants were randomized to receive matching placebo for 6 weeks.
Secondary
Number of Participants Who Required Rescue With RBC Transfusion From Baseline to the End of the Dose Adjustment and Maintenance Period
Participants who initiated rescue therapy (including RBC transfusion) were required to stop study drug treatment and were discontinued from the study.
mITT Population. Only participants with available data were analyzed.
Posted
Count of Participants
Participants
Baseline; Week 16
ID
Title
Description
OG000
Vadadustat 150 mg
Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG001
Vadadustat 300 mg
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG002
Vadadustat 600 mg
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
Secondary
Number of Participants Who Required Rescue With Erythropoiesis-Stimulating Agents (ESAs) From Baseline to the End of the Primary Efficacy Period
ESA rescue is defined as participants with ESA administration and 1) the participant experienced a clinically significant worsening of their anemia or symptoms of anemia, 2) the participant's Hb level is <9.0 g/dL, and 3) reason for early study withdrawal of worsening of anemia requiring ESA rescue or blood transfusion. Participants who initiated rescue therapy (including ESAs) were required to stop study drug treatment and were discontinued from the study.
mITT Population. Only participants with available data were analyzed.
Posted
Count of Participants
Participants
Baseline; Week 6
ID
Title
Description
OG000
Vadadustat 150 mg
Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks.
OG001
Vadadustat 300 mg
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.
OG002
Vadadustat 600 mg
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.
Secondary
Number of Participants Who Required Rescue With ESAs From Baseline to the End of the Dose Adjustment and Maintenance Period
ESA rescue is defined as participants with ESA administration and 1) the participant experienced a clinically significant worsening of their anemia or symptoms of anemia, 2) the participant's Hb level is <9.0 g/dL, and 3) reason for early study withdrawal of worsening of anemia requiring ESA rescue or blood transfusion. Participants who initiated rescue therapy (including ESAs) were required to stop study drug treatment and were discontinued from the study.
mITT Population. Only participants with available data were analyzed.
Posted
Count of Participants
Participants
Baseline; Week 16
ID
Title
Description
OG000
Vadadustat 150 mg
Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks during the Primary efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG001
Vadadustat 300 mg
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
Secondary
Number of the Participants With the Indicated Number of Dose Adjustments From Baseline to the End of the Dose Adjustment and Maintenance Period
Increases in dose were not allowed during the 6-week Primary Efficacy Period.
mITT Population
Posted
Count of Participants
Participants
up to Week 16
ID
Title
Description
OG000
Vadadustat 150 mg
Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG001
Vadadustat 300 mg
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG002
Vadadustat 600 mg
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
Secondary
Plasma Concentration Profile of Vadadustat and Its Metabolites Using a Pre-dose Sample From Week 4
Blood samples were collected for analysis.
Pharmacokinetic (PK) Population: all participants in the Safety Population (all enrolled participants who received at least 1 dose of study medication) who had a pre-dose PK sample at Week 4
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Week 4, pre-dose
ID
Title
Description
OG000
Vadadustat 150 mg
Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks.
OG001
Vadadustat 300 mg
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.
OG002
Vadadustat 600 mg
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.
OG003
Placebo
Participants were randomized to receive matching placebo for 6 weeks.
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs) in the Primary Efficacy Period
An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. An AE that met one or more of the following criteria or outcomes was classified as serious: death; life-threatening; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; was considered a medically important event not meeting the above criteria, but which could jeopardize a participant, or could require medical or surgical intervention to prevent one of the criteria listed in this definition.
Safety Population: all enrolled participants who received at least 1 dose of study medication. The Safety Population was based on the actual treatment that participants received
Posted
Count of Participants
Participants
up to Week 6
ID
Title
Description
OG000
Vadadustat 150 mg
Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks.
OG001
Vadadustat 300 mg
Secondary
Number of Participants With TEAEs and Treatment-emergent SAEs in the Dose Adjustment and Maintenance Period
An AE was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. An AE that met one or more of the following criteria or outcomes was classified as serious: death; life-threatening; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; was considered a medically important event not meeting the above criteria, but which could jeopardize a participant, or could require medical or surgical intervention to prevent one of the criteria listed in this definition.
Safety Population
Posted
Count of Participants
Participants
up to Week 16
ID
Title
Description
OG000
Vadadustat 150 mg
Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG001
Vadadustat 300 mg
Time Frame
up to Week 18
Description
Not provided
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
Primary Efficacy Period: 150 mg Vadadustat
Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.
8
15
0
15
8
15
EG001
Primary Efficacy Period: 300 mg Vadadustat
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.
11
15
0
15
11
15
EG002
Primary Efficacy Period: 600 mg Vadadustat
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.
6
15
3
15
5
15
EG003
Primary Efficacy Period: Placebo Matched to 150 mg Vadadustat
Participants were randomized to receive matching placebo for 6 weeks.
2
5
0
5
2
5
EG004
Primary Efficacy Period: Placebo Matched to 300 mg Vadadustat
Participants were randomized to receive matching placebo for 6 weeks.
2
5
1
5
2
5
EG005
Primary Efficacy Period: Placebo Matched to 600 mg Vadadustat
Participants were randomized to receive matching placebo for 6 weeks.
2
5
0
5
2
5
EG006
Dose Adjustment and Maintenance: 150 mg Vadadustat
Participants were randomized to receive vadadustat 150 mg, administered as 1 tablet QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target hemoglobin (Hb) of 10.0 to 12.0 grams/deciliter (g/dL) based on dose adjustment guidelines.
9
15
1
15
9
15
EG007
Dose Adjustment and Maintenance: 300 mg Vadadustat
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
9
15
1
15
9
15
EG008
Dose Adjustment and Maintenance: 600 mg Vadadustat
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
9
15
1
15
9
15
EG009
Dose Adjustment and Maintenance: Placebo to 150 mg Vadadustat
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period.
During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 150 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
1
5
0
5
1
5
EG010
Dose Adjustment and Maintenance: Placebo to 300 mg Vadadustat
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period.
During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 300 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
1
5
0
5
1
5
EG011
Dose Adjustment and Maintenance: Placebo to 600 mg Vadadustat
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period.
During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 600 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
2
5
0
5
2
5
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pericarditis
Cardiac disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0021 affected15 at risk
EG0030 affected5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
Gastric ulcer haemorrhage
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected15 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0021 affected15 at risk
EG003
Enteritis infectious
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0021 affected15 at risk
EG003
Arteriovenous fistula site complication
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected15 at risk
EG003
Shunt stenosis
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0021 affected15 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected15 at risk
EG003
Toxic encephalopathy
Nervous system disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0021 affected15 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected15 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0021 affected15 at risk
EG0030 affected5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
Constipation
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected15 at risk
EG0011 affected15 at risk
EG0020 affected15 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected15 at risk
EG0012 affected15 at risk
EG0022 affected15 at risk
EG003
Faeces soft
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected15 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected15 at risk
EG003
Pancreatic cyst
Gastrointestinal disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected15 at risk
EG003
Chest discomfort
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected15 at risk
EG003
Pyrexia
General disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected15 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected15 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0021 affected15 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0001 affected15 at risk
EG0015 affected15 at risk
EG0021 affected15 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected15 at risk
EG003
Tracheobronchitis
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected15 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected15 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0021 affected15 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected15 at risk
EG003
Foreign body
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0021 affected15 at risk
EG003
Shunt stenosis
Injury, poisoning and procedural complications
MedDRA 20.0
Non-systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0021 affected15 at risk
EG003
Blood parathyroid hormone increased
Investigations
MedDRA 20.0
Non-systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected15 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected15 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0001 affected15 at risk
EG0010 affected15 at risk
EG0020 affected15 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected15 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected15 at risk
EG0010 affected15 at risk
EG0020 affected15 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Non-systematic Assessment
EG0000 affected15 at risk
EG0011 affected15 at risk
EG0020 affected15 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The ANCOVA model includes treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.
<0.0001
Least squares mean difference
1.56
Standard Error of the Mean
0.315
2-Sided
95
0.93
2.19
Superiority
OG002
OG003
ANCOVA
The ANCOVA model includes treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.
<0.0001
Least squares mean difference
1.89
Standard Error of the Mean
0.326
2-Sided
95
1.23
2.54
Superiority
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG003
Placebo to Vadadustat 150 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 150 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG004
Placebo to Vadadustat 300 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 300 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG005
Placebo to Vadadustat 600 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 600 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
Units
Counts
Participants
OG0008
OG00112
OG00211
OG0030
OG0042
OG0051
Title
Denominators
Categories
Title
Measurements
OG00069.3± 25.31
OG00179.2± 24.94
OG00254.6± 27.90
OG00457.0± 19.80
OG00585.0± NAA standard deviation was not calculated for a single participant.
Units
Counts
Participants
OG00011
OG00113
OG00213
OG0036
Title
Denominators
Categories
Title
Measurements
OG0009.064± 1.0652
OG0019.062± 0.8412
OG0029.969± 0.7296
OG0037.817± 1.4662
OG003
Placebo to Vadadustat 150 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 150 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG004
Placebo to Vadadustat 300 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 300 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG005
Placebo to Vadadustat 600 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 600 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
Units
Counts
Participants
OG00010
OG00113
OG00212
OG0032
OG0041
OG0052
Title
Denominators
Categories
Title
Measurements
OG00010.460± 0.7501
OG00111.285± 1.7841
OG00211.100± 1.1402
OG0038.600± 0.9899
OG00413.200± NAA standard deviation was not calculated for a single participant.
OG00512.100± 1.5556
OG003
Placebo to Vadadustat 150 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 150 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG004
Placebo to Vadadustat 300 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 300 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG005
Placebo to Vadadustat 600 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 600 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
Units
Counts
Participants
OG00010
OG00113
OG00212
OG0032
OG0041
OG0052
Title
Denominators
Categories
Title
Measurements
OG0007
OG00111
OG0027
OG0030
OG0040
OG0051
OG003
Placebo to Vadadustat 150 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 150 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG004
Placebo to Vadadustat 300 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 300 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG005
Placebo to Vadadustat 600 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 600 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
Units
Counts
Participants
OG00010
OG00113
OG00212
OG0032
OG0041
OG0052
Title
Denominators
Categories
Title
Measurements
OG0001.397± 0.5755
OG0012.444± 1.7807
OG0021.644± 1.4973
OG003-0.233± 0.1414
OG0043.800± NAA standard deviation was not calculated for a single participant.
OG0053.000± 0.2828
Units
Counts
Participants
OG00011
OG00113
OG00213
OG0036
Title
Denominators
Categories
RBC Count
Title
Measurements
OG000-0.01± 0.073
OG0010.08± 0.069
OG0020.20± 0.069
OG003-0.30± 0.099
Absolute Reticulocyte Count
Title
Measurements
OG0000.02± 0.005
OG0010.02± 0.004
OG0020.03± 0.004
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
OG003
RBC Count
ANCOVA
The ANCOVA model will include treatment assignment (3 dosed groups;1 placebo group) and pre-treatment Hb value as a covariate.
0.0232
Least squares mean difference
0.29
Standard Error of the Mean
0.122
2-Sided
95
0.04
0.54
Superiority
OG001
OG003
RBC Count
ANCOVA
The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.
0.0033
Least squares mean difference
0.38
Standard Error of the Mean
0.121
2-Sided
95
0.13
0.62
Superiority
OG002
OG003
RBC Count
ANCOVA
The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.
0.0002
Least squares mean difference
0.50
Standard Error of the Mean
0.120
2-Sided
95
0.26
0.74
Superiority
OG000
OG003
Absolute Reticulocyte Count
ANCOVA
The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.
0.3289
Least squares mean difference
0.01
Standard Error of the Mean
0.008
2-Sided
94
-0.01
0.02
Superiority
OG001
OG003
Absolute Reticulocyte Count
ANCOVA
The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.
0.2607
Least squares mean difference
0.01
Standard Error of the Mean
0.007
2-Sided
95
-0.01
0.02
Superiority
OG002
OG003
Absolute Reticulocyte Count
ANCOVA
The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.
0.0252
Least squares mean difference
0.02
Standard Error of the Mean
0.007
2-Sided
95
0.00
0.03
Superiority
OG003
Placebo to Vadadustat 150 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 150 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG004
Placebo to Vadadustat 300 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 300 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG005
Placebo to Vadadustat 600 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 600 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
Units
Counts
Participants
OG00010
OG00113
OG00212
OG0032
OG0041
OG0052
Title
Denominators
Categories
RBC Count
Title
Measurements
OG0000.454± 0.2225
OG0010.819± 0.5127
OG0020.503± 0.5056
OG0030.065± 0.0212
OG0041.160± NAA standard deviation was not calculated for a single participant.
OG0051.035± 0.0778
Absolute Reticulocyte Count
Title
Measurements
OG0000.017± 0.0169
OG0010.021± 0.0180
OG0020.016± 0.0162
OG003
Units
Counts
Participants
OG00011
OG00113
OG00213
OG0036
Title
Denominators
Categories
Hematocrit
Title
Measurements
OG0000.67± 0.770
OG0011.98± 0.737
OG0023.30± 0.737
OG003-2.63± 1.045
Reticulocytes
Title
Measurements
OG0000.64± 0.158
OG0010.57± 0.141
OG0020.71± 0.140
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
OG003
Hematocrit
ANCOVA
The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.
0.0154
Least squares mean difference
3.31
Standard Error of the Mean
1.303
2-Sided
95
0.67
5.94
Superiority
OG001
OG003
Hematocrit
ANCOVA
The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.
0.0008
Least squares mean difference
4.61
Standard Error of the Mean
1.261
2-Sided
95
2.06
7.16
Superiority
OG002
OG003
Hematocrit
ANCOVA
The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.
<0.0001
Least squares mean difference
5.93
Standard Error of the Mean
1.296
2-Sided
95
3.31
8.56
Superiority
OG000
OG003
Reticulocytes
ANCOVA
The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.
0.3572
Least squares mean difference
0.25
Standard Error of the Mean
0.273
2-Sided
95
-0.30
0.81
Superiority
OG001
OG003
Reticulocytes
ANCOVA
The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.
0.4758
Least squares mean difference
0.18
Standard Error of the Mean
0.252
2-Sided
95
-0.33
0.69
Superiority
OG002
OG003
Reticulocytes
ANCOVA
The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.
0.2048
Least squares mean difference
0.33
Standard Error of the Mean
0.254
2-Sided
95
-0.19
0.84
Superiority
OG003
Placebo to Vadadustat 150 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 150 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG004
Placebo to Vadadustat 300 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 300 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG005
Placebo to Vadadustat 600 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 600 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
Units
Counts
Participants
OG00010
OG00113
OG00212
OG0032
OG0041
OG0052
Title
Denominators
Categories
Hematocrit
Title
Measurements
OG0005.12± 2.105
OG0018.92± 5.100
OG0025.63± 4.921
OG0031.20± 0.000
OG00412.90± NAA standard deviation was not calculated for a single participant.
OG00510.70± 1.697
Reticulocytes
Title
Measurements
OG0000.32± 0.636
OG0010.33± 0.686
OG0020.24± 0.547
OG003
Units
Counts
Participants
OG00011
OG00113
OG00213
OG0036
Title
Denominators
Categories
Iron
Title
Measurements
OG000-3.3± 26.60
OG001-1.5± 19.50
OG002-8.1± 21.95
OG003-1.5± 26.64
TIBC
Title
Measurements
OG00035.4± 28.72
OG00167.5± 25.72
OG00280.7± 39.04
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
OG003
Iron
ANCOVA
test of treatment group difference based on ANCOVA model
0.9373
Superiority
OG001
OG003
Iron
ANCOVA
test of treatment group difference based on ANCOVA model
0.6623
Superiority
OG002
OG003
Iron
ANCOVA
test of treatment group difference based on ANCOVA model
0.9374
Superiority
OG000
OG003
TIBC
ANCOVA
test of treatment group difference based on ANCOVA model
0.2085
Superiority
OG001
OG003
TIBC
ANCOVA
test of treatment group difference based on ANCOVA model
0.0016
Superiority
OG002
OG003
TIBC
ANCOVA
test of treatment group difference based on ANCOVA model
0.0001
Superiority
OG003
Placebo to Vadadustat 150 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 150 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG004
Placebo to Vadadustat 300 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 300 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG005
Placebo to Vadadustat 600 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 600 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
Units
Counts
Participants
OG00010
OG00113
OG00212
OG0032
OG0041
OG0052
Title
Denominators
Categories
Iron
Title
Measurements
OG000-18.5± 24.01
OG001-8.7± 24.29
OG0020.9± 48.22
OG003-9.5± 30.41
OG004-7.0± NAA standard deviation was not calculated for a single participant.
OG00515.0± 43.84
TIBC
Title
Measurements
OG00058.5± 44.12
OG00180.9± 29.42
OG00285.4± 39.91
OG003
Units
Counts
Participants
OG00011
OG00113
OG00213
OG0036
Title
Denominators
Categories
Title
Measurements
OG000-6.51± 11.621
OG001-10.14± 11.294
OG002-12.46± 9.544
OG003-2.78± 12.822
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
OG003
ANCOVA
test of treatment group difference based on ANCOVA model
0.2708
Superiority
OG001
OG003
ANCOVA
test of treatment group difference based on ANCOVA model
0.0966
Superiority
OG002
OG003
ANCOVA
test of treatment group difference based on ANCOVA model
0.0424
Superiority
OG003
Placebo to Vadadustat 150 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 150 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG004
Placebo to Vadadustat 300 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 300 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG005
Placebo to Vadadustat 600 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 600 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
Units
Counts
Participants
OG00010
OG00113
OG00212
OG0032
OG0041
OG0052
Title
Denominators
Categories
Title
Measurements
OG000-14.25± 12.069
OG001-13.79± 13.549
OG002-10.93± 12.627
OG003-12.50± 18.526
OG004-17.10± NAA standard deviation was not calculated for a single participant.
OG005-4.70± 12.021
Units
Counts
Participants
OG00011
OG00113
OG00213
OG0036
Title
Denominators
Categories
Ferritin
Title
Measurements
OG000-51.20± 58.855
OG001-68.67± 54.707
OG002-104.49± 49.558
OG00312.63± 32.424
Hepcidin
Title
Measurements
OG000-53.465± 43.5531
OG001-73.587± 32.3547
OG002-104.301± 36.7636
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
OG003
Ferritin
ANCOVA
test of treatment group difference based on ANCOVA model
0.0207
Superiority
OG001
OG003
Ferritin
ANCOVA
test of treatment group difference based on ANCOVA model
0.0022
Superiority
OG002
OG003
Ferritin
ANCOVA
test of treatment group difference based on ANCOVA model
<0.0001
Superiority
OG000
OG003
Hepcidin
ANCOVA
test of treatment group difference based on ANCOVA model
0.0062
Superiority
OG001
OG003
Hepcidin
ANCOVA
test of treatment group difference based on ANCOVA model
0.0002
Superiority
OG002
OG003
Hepcidin
ANCOVA
<0.0001
test of treatment group difference based on ANCOVA model
Superiority
OG003
Placebo to Vadadustat 150 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 150 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG004
Placebo to Vadadustat 300 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 300 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG005
Placebo to Vadadustat 600 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 600 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
Units
Counts
Participants
OG00010
OG00113
OG00212
OG0032
OG0041
OG0052
Title
Denominators
Categories
Ferritin
Title
Measurements
OG000-105.09± 55.837
OG001-119.28± 84.000
OG002-113.52± 54.559
OG003-43.05± 81.954
OG004-150.70± NAA standard deviation was not calculated for a single participant.
OG005-76.95± 42.356
Hepcidin
Title
Measurements
OG000-73.826± 50.9042
OG001-99.367± 51.3174
OG002-106.838± 40.1472
OG003
Units
Counts
Participants
OG00015
OG00115
OG00214
OG00314
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG0033
OG003
Placebo to Vadadustat 150 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 150 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG004
Placebo to Vadadustat 300 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 300 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG005
Placebo to Vadadustat 600 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 600 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
Units
Counts
Participants
OG00015
OG00115
OG00214
OG0035
OG0044
OG0055
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG003
Placebo
Participants were randomized to receive matching placebo for 6 weeks.
Units
Counts
Participants
OG00015
OG00115
OG00214
OG00314
Title
Denominators
Categories
Title
Measurements
OG0004
OG0012
OG0021
OG0038
OG002
Vadadustat 600 mg
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG003
Placebo to Vadadustat 150 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 150 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG004
Placebo to Vadadustat 300 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 300 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG005
Placebo to Vadadustat 600 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 600 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
Units
Counts
Participants
OG00015
OG00115
OG00214
OG0035
OG0044
OG0055
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG003
Placebo to Vadadustat 150 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 150 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG004
Placebo to Vadadustat 300 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 300 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG005
Placebo to Vadadustat 600 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 600 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
Units
Counts
Participants
OG00015
OG00115
OG00214
OG0035
OG0044
OG0055
Title
Denominators
Categories
0 dose adjustments
Title
Measurements
OG0005
OG0013
OG0029
OG0032
OG0043
OG0053
1 dose adjustment
Title
Measurements
OG0002
OG0012
OG0022
OG003
2 dose adjustments
Title
Measurements
OG0005
OG0018
OG0023
OG003
3 or more dose adjustments
Title
Measurements
OG0003
OG0012
OG0020
OG003
Units
Counts
Participants
OG00012
OG00113
OG00213
OG0030
Title
Denominators
Categories
Vadadustat
Title
Measurements
OG0004343.54± 175.17
OG0017561.36± 134.77
OG00215083.03± 46.77
O-glucuronide
Title
Measurements
OG0008667.97± 73.79
OG00114623.89± 67.44
OG00236476.33± 57.18
Acyl-glucuronide
Title
Measurements
OG00012.019± 16.55
OG00112.174± 8.10
OG00222.765± 70.53
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.
OG002
Vadadustat 600 mg
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.
OG003
Placebo
Participants were randomized to receive matching placebo for 6 weeks.
Units
Counts
Participants
OG00015
OG00115
OG00215
OG00315
Title
Denominators
Categories
TEAEs
Title
Measurements
OG0008
OG00111
OG0026
OG0036
Treatment-emergent SAEs
Title
Measurements
OG0000
OG0010
OG0023
OG003
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG002
Vadadustat 600 mg
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG003
Placebo to Vadadustat 150 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 150 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG004
Placebo to Vadadustat 300 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 300 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
OG005
Placebo to Vadadustat 600 mg
Participants were randomized to receive matching placebo for 6 weeks during the Primary Efficacy Period. During the 10-week Dose Adjustment and Maintenance Period, participants randomized to receive placebo in the 6-week Efficacy Period were switched to vadadustat 600 mg, and the dose was adjusted to achieve a target Hb of 10.0 to 12.0 g/dL based on dose adjustment guidelines.
Units
Counts
Participants
OG00015
OG00115
OG00215
OG0035
OG0045
OG0055
Title
Denominators
Categories
TEAEs
Title
Measurements
OG0009
OG0019
OG0029
OG0031
OG0041
OG0052
Treatment-emergent SAEs
Title
Measurements
OG0001
OG0011
OG0021
OG003
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0041 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
1 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected15 at risk
EG0091 affected5 at risk
EG0100 affected5 at risk
EG0111 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0051 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0041 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0111 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0064 affected15 at risk
EG0072 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0101 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0091 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0041 affected5 at risk
EG0050 affected5 at risk
EG0062 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0051 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
1 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0041 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
1 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0062 affected15 at risk
EG0070 affected15 at risk
EG0081 affected15 at risk
EG0091 affected5 at risk
EG0100 affected5 at risk
EG0111 affected5 at risk
0 affected
5 at risk
EG0041 affected5 at risk
EG0050 affected5 at risk
EG0061 affected15 at risk
EG0071 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0061 affected15 at risk
EG0071 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0051 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0111 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0111 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0111 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0101 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0081 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0111 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0111 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
0 affected
5 at risk
EG0040 affected5 at risk
EG0050 affected5 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected15 at risk
EG0090 affected5 at risk
EG0100 affected5 at risk
EG0110 affected5 at risk
2
BG0053
BG00641
0.01
± 0.006
0.016
± 0.0083
OG0040.024± NAA standard deviation was not calculated for a single participant.
OG0050.014± 0.0217
0.39
± 0.212
0.55
± 0.212
OG0040.40± NAA standard deviation was not calculated for a single participant.
OG0050.15± 0.636
15.8
± 8.08
33.0
± 2.83
OG004108.0± NAA standard deviation was not calculated for a single participant.
OG00578.0± 62.23
-11.802
± 13.6518
-95.940
± 98.7262
OG004-122.300± NAA standard deviation was not calculated for a single participant.