Dose-Finding Study of Vadadustat in Japanese Subjects Wit... | NCT03054337 | Trialant
NCT03054337
Sponsor
Akebia Therapeutics
Status
Completed
Last Update Posted
Apr 8, 2021Actual
Enrollment
51Actual
Phase
Phase 2
Conditions
Anemia
Non-dialysis Dependent Chronic Kidney Disease
Interventions
Vadadustat
Placebo
Countries
Japan
Protocol Section
Identification Module
NCT ID
NCT03054337
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
AKB-6548-CI-0021
Secondary IDs
Not provided
Brief Title
Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Non-Dialysis Dependent Chronic Kidney Disease (NDD-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 Non-Dialysis Dependent Chronic Kidney Disease (NDD-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
Oct 2016Actual
Primary Completion Date
Jul 4, 2017Actual
Completion Date
Aug 28, 2017Actual
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
No
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 Non-dialysis Dependent Chronic Kidney Disease (NDD-CKD).
Detailed Description
Not provided
Conditions Module
Conditions
Anemia
Non-dialysis Dependent Chronic Kidney Disease
Keywords
Anemia
kidney
non-dialysis dependent chronic kidney disease
CKD
NDD-CKD
renal
vadadustat
AKB-6548
hypoxia-inducible factor
hypoxia-inducible factor (HIF)
HIF
prolyl-hydroxylase inhibitor (PHI)
PHI
Japan
Japanese
Akebia (AKB)
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
51Actual
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
Vadadustat, Dose 1
Vadadustat, Dose 2
Vadadustat, Dose 3
AKB-6548
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 value for Hb was defined as the average of 2 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
Diagnosis of chronic kidney disease (CKD) based on an estimated glomerular filtration rate ≤60 milliliters per minute per 1.73 meters squared (mL/min/1.73 m^2)
Hemoglobin (Hb) ≤10.5 grams per deciliter (g/dL)
Not currently being treated with dialysis and not expected to start dialysis within 3 months of screening
Exclusion Criteria:
Anemia due to a cause other than 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
Intravenous iron within 4 weeks prior to or during screening
Any use of erythropoiesis-stimulating agents within 6 weeks prior to or during screening
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
Not provided
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.
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
The pre-treatment value for Hb was defined as the average of 2 values obtained prior to treatment, i.e., the qualifying screening value 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 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 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 a 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 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.
Baseline to Week 16
Number of Participants Who Maintained Iron Sufficiency From Baseline to Week 6
Iron sufficiency was defined as ferritin ≥50 ng/mL and TSAT ≥20%.
Baseline to Week 6
Number of Participants Who Maintained Iron Sufficiency From Baseline to Week 16
Iron sufficiency was defined as ferritin ≥50 ng/mL and TSAT ≥20%.
Baseline 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
Chiba
Japan
Ehime
Japan
Gunma
Japan
Hiroshima
Japan
Hokkaido
Japan
Hyōgo
Japan
Ibaraki
Japan
Kanagawa
Japan
Nagano
Japan
Nara
Japan
Niigata
Japan
Okayama
Japan
Okinawa
Japan
Osaka
Japan
Ōita
Japan
Shiga
Japan
Tokushima
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.
FG00012 subjects
FG00112 subjects
FG00213 subjects
FG0035 subjects
FG0044 subjects
FG0055 subjects
COMPLETED
FG00012 subjects
FG00112 subjects
FG00213 subjects
FG0035 subjects
FG0044 subjects
FG0055 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Dose Adjustment and Maintenance Period
Type
Comment
Milestone Data
STARTED
FG00012 subjects
FG00112 subjects
FG00213 subjects
FG0035 subjects
FG0044 subjects
FG0055 subjects
COMPLETED
FG00011 subjects
FG00110 subjects
FG00212 subjects
FG0035 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Investigator discretion
FG0001 subjects
FG0012 subjects
FG0021 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
BG00012
BG00112
BG00213
BG0035
BG0044
BG0055
BG00651
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
ParticipantsBG00012
ParticipantsBG00112
ParticipantsBG00213
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00012
ParticipantsBG00112
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
Mean
Standard Deviation
grams per deciliter (g/dL)
Title
Denominators
Categories
ParticipantsBG00012
ParticipantsBG00112
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 value for Hb was defined as the average of 2 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
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
OG00012
OG00112
OG00213
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.43± 0.224
OG0011.13± 0.223
OG0021.62± 0.215
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 included treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.
0.0045
Least squares mean difference
0.90
Standard Error of the Mean
0.301
2-Sided
95
0.29
1.51
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 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 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 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
The pre-treatment value for Hb was defined as the average of 2 values obtained prior to treatment, i.e., the qualifying screening value 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
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 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 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 participant 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 a 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 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. Only participants with available data were analyzed.
Posted
Count of Participants
Participants
Baseline 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
Number of Participants Who Maintained Iron Sufficiency From Baseline to Week 6
Iron sufficiency was defined as ferritin ≥50 ng/mL and TSAT ≥20%.
mITT Population. Only participants with available data were analyzed.
Posted
Count of Participants
Participants
Baseline 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
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 Maintained Iron Sufficiency From Baseline to Week 16
Iron sufficiency was defined as ferritin ≥50 ng/mL and TSAT ≥20%.
mITT Population. Only participants with available data were analyzed.
Posted
Count of Participants
Participants
Baseline 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
Mean
Standard Deviation
micrograms per milliliter (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.
0
12
0
12
4
12
EG001
Primary Efficacy Period: 300 mg Vadadustat
Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.
0
12
0
12
7
12
EG002
Primary Efficacy Period: 600 mg Vadadustat
Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.
0
13
0
13
7
13
EG003
Primary Efficacy Period: Placebo Matched to 150 mg Vadadustat
Participants were randomized to receive matching placebo for 6 weeks.
0
5
0
5
0
5
EG004
Primary Efficacy Period: Placebo Matched to 300 mg Vadadustat
Participants were randomized to receive matching placebo for 6 weeks.
0
4
0
4
2
4
EG005
Primary Efficacy Period: Placebo Matched to 600 mg Vadadustat
Participants were randomized to receive matching placebo for 6 weeks.
0
5
0
5
3
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 per deciliter (g/dL) based on dose adjustment guidelines.
0
12
0
12
9
12
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.
0
12
5
12
10
12
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.
0
13
2
13
6
13
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.
0
5
1
5
2
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.
0
4
1
4
2
4
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.
The ANCOVA model included treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.
<0.0001
Least squares mean difference
1.59
Standard Error of the Mean
0.306
2-Sided
95
0.98
2.21
Superiority
OG002
OG003
ANCOVA
The ANCOVA model included treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.
<0.0001
Least squares mean difference
2.09
Standard Error of the Mean
0.300
2-Sided
95
1.49
2.70
Superiority
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 hemoglobin 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
OG0006
OG0017
OG0028
OG0032
OG0043
OG0054
Title
Denominators
Categories
Title
Measurements
OG00056.8± 43.31
OG00139.0± 38.52
OG00225.6± 16.47
OG00379.0± 11.31
OG00471.0± 14.00
OG00554.5± 33.67
Units
Counts
Participants
OG00012
OG00112
OG00213
OG00314
Title
Denominators
Categories
Title
Measurements
OG00010.392± 0.7280
OG00110.675± 1.2693
OG00211.162± 1.1169
OG0039.421± 0.9242
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
OG00011
OG00110
OG00212
OG0035
OG0044
OG0054
Title
Denominators
Categories
Title
Measurements
OG00010.973± 0.5711
OG00111.230± 0.7514
OG00211.342± 0.6473
OG00310.860± 0.5857
OG00411.425± 0.9179
OG00511.950± 0.6608
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
OG00011
OG00110
OG00212
OG0035
OG0044
OG0054
Title
Denominators
Categories
Title
Measurements
OG00011
OG0018
OG00211
OG0035
OG0043
OG0052
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
OG00011
OG00110
OG00212
OG0035
OG0044
OG0054
Title
Denominators
Categories
Title
Measurements
OG0000.982± 0.3676
OG0011.610± 1.1692
OG0021.779± 0.8117
OG0030.790± 0.3070
OG0041.538± 0.5250
OG0052.075± 0.2784
Units
Counts
Participants
OG00012
OG00112
OG00213
OG00314
Title
Denominators
Categories
RBC Count
Title
Measurements
OG0000.17± 0.075
OG0010.34± 0.075
OG0020.48± 0.073
OG003-0.17± 0.070
Absolute Reticulocyte Count
Title
Measurements
OG0000.01± 0.004
OG0010.01± 0.003
OG0020.01± 0.003
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.
0.0018
Least squares mean difference
0.34
Standard Error of the Mean
0.103
2-Sided
95
0.13
0.55
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.
<0.0001
Least squares mean difference
0.51
Standard Error of the Mean
0.103
2-Sided
95
0.30
0.72
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.
<0.0001
Least squares mean difference
0.66
Standard Error of the Mean
0.102
2-Sided
95
0.45
0.86
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.
0.7804
Least squares mean difference
0.00
Standard Error of the Mean
0.005
2-Sided
95
-0.01
0.01
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.
0.0986
Least squares mean difference
0.01
Standard Error of the Mean
0.005
2-Sided
95
-0.00
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.
0.1661
Least squares mean difference
0.01
Standard Error of the Mean
0.005
2-Sided
95
-0.00
0.02
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
OG00011
OG00110
OG00212
OG0035
OG0044
OG0054
Title
Denominators
Categories
RBC Count
Title
Measurements
OG0000.305± 0.1870
OG0010.476± 0.4406
OG0020.593± 0.3186
OG0030.186± 0.2165
OG0040.438± 0.2175
OG0050.608± 0.1771
Absolute Reticulocyte Count
Title
Measurements
OG0000.003078± 0.0094008
OG0010.008001± 0.0156884
OG0020.000196± 0.0085029
OG003
Units
Counts
Participants
OG00012
OG00112
OG00213
OG00314
Title
Denominators
Categories
Hematocrit
Title
Measurements
OG0002.13± 0.696
OG0014.13± 0.696
OG0026.07± 0.667
OG003-1.17± 0.643
Reticulocytes
Title
Measurements
OG0000.16± 0.111
OG0010.28± 0.111
OG0020.19± 0.107
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.
0.0010
Least squares mean difference
3.30
Standard Error of the Mean
0.942
2-Sided
95
1.40
5.20
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.
<0.0001
Least squares mean difference
5.30
Standard Error of the Mean
0.953
2-Sided
95
3.38
7.22
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
7.24
Standard Error of the Mean
0.930
2-Sided
95
5.37
9.11
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.
0.5889
Least squares mean difference
-0.08
Standard Error of the Mean
0.152
2-Sided
95
-0.39
0.22
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.
0.8074
Least squares mean difference
0.04
Standard Error of the Mean
0.151
2-Sided
95
-0.27
0.34
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.
0.6952
Least squares mean difference
-0.06
Standard Error of the Mean
0.148
2-Sided
95
-0.36
0.24
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
OG00011
OG00110
OG00212
OG0035
OG0044
OG0054
Title
Denominators
Categories
Hematocrit
Title
Measurements
OG0003.28± 1.947
OG0015.17± 4.991
OG0025.39± 2.844
OG0032.32± 1.827
OG0045.80± 1.566
OG0056.05± 1.997
Reticulocytes
Title
Measurements
OG000-0.02± 0.232
OG0010.07± 0.442
OG002-0.18± 0.279
OG003
Units
Counts
Participants
OG00012
OG00112
OG00213
OG00314
Title
Denominators
Categories
Iron
Title
Measurements
OG000-1.8± 19.58
OG001-2.4± 20.75
OG0024.4± 30.82
OG003-7.4± 19.92
TIBC
Title
Measurements
OG00044.9± 32.9
OG00175.2± 35.60
OG00293.8± 44.74
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
0.3702
Superiority
OG001
OG003
Iron
ANCOVA
test of treatment group difference based on ANCOVA model
0.5524
Superiority
OG002
OG003
Iron
ANCOVA
test of treatment group difference based on ANCOVA model
0.1589
Superiority
OG000
OG003
TIBC
ANCOVA
test of treatment group difference based on ANCOVA model
0.0092
Superiority
OG001
OG003
TIBC
ANCOVA
test of treatment group difference based on ANCOVA model
<0.0001
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
OG00011
OG00110
OG00212
OG0035
OG0044
OG0054
Title
Denominators
Categories
Iron
Title
Measurements
OG00011.7± 38.25
OG0013.5± 31.17
OG00211.5± 28.56
OG003-1.4± 21.82
OG0045.5± 24.66
OG0055.8± 25.59
TIBC
Title
Measurements
OG00051.8± 48.41
OG00143.4± 42.77
OG00242.8± 28.28
OG003
Units
Counts
Participants
OG00012
OG00112
OG00213
OG00314
Title
Denominators
Categories
Title
Measurements
OG000-4.96± 7.343
OG001-7.31± 8.380
OG002-6.78± 10.609
OG003-4.72± 8.931
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
0.9092
Superiority
OG001
OG003
ANCOVA
test of treatment group difference based on ANCOVA model
0.1484
Superiority
OG002
OG003
ANCOVA
test of treatment group difference based on ANCOVA model
0.1313
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
OG00011
OG00110
OG00212
OG0035
OG0044
OG0054
Title
Denominators
Categories
Title
Measurements
OG000-1.47± 10.365
OG001-2.68± 13.201
OG002-0.19± 9.857
OG003-7.00± 12.247
OG004-5.03± 11.342
OG005-2.68± 10.608
Units
Counts
Participants
OG00012
OG00112
OG00213
OG00314
Title
Denominators
Categories
Ferritin
Title
Measurements
OG000-38.48± 34.227
OG001-69.36± 49.965
OG002-101.54± 57.697
OG003-11.44± 31.408
Hepcidin
Title
Measurements
OG000-24.622± 20.0165
OG001-40.819± 27.2486
OG002-37.964± 21.0819
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
0.1080
Superiority
OG001
OG003
Ferritin
ANCOVA
test of treatment group difference based on ANCOVA model
0.0002
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
0.0672
Superiority
OG001
OG003
Hepcidin
ANCOVA
test of treatment group difference based on ANCOVA model
0.0004
Superiority
OG002
OG003
Hepcidin
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
OG00011
OG00110
OG00212
OG0035
OG0044
OG0054
Title
Denominators
Categories
Ferritin
Title
Measurements
OG000-79.45± 39.655
OG001-62.35± 36.808
OG002-59.68± 59.843
OG003-69.26± 46.519
OG004-146.63± 34.261
OG005-59.43± 13.618
Hepcidin
Title
Measurements
OG000-29.522± 22.7101
OG001-23.061± 53.0161
OG002-2.502± 21.2660
OG003
OG003
Placebo
Participants were randomized to receive matching placebo for 6 weeks.
Units
Counts
Participants
OG00012
OG00112
OG00213
OG00314
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
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
OG00012
OG00112
OG00213
OG0035
OG0044
OG0055
Title
Denominators
Categories
Title
Measurements
OG0000
OG0012
OG0021
OG0030
OG0040
OG0050
Units
Counts
Participants
OG00012
OG00112
OG00213
OG00314
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
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
OG00012
OG00112
OG00213
OG0035
OG0044
OG0055
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0021
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
OG00012
OG00112
OG00213
OG0035
OG0044
OG0055
Title
Denominators
Categories
0 dose adjustments
Title
Measurements
OG0003
OG0011
OG0022
OG0030
OG0040
OG0051
1 dose adjustment
Title
Measurements
OG0005
OG0017
OG0021
OG003
2 dose adjustments
Title
Measurements
OG0003
OG0014
OG0023
OG003
3 or more dose adjustments
Title
Measurements
OG0001
OG0010
OG0027
OG003
Units
Counts
Participants
OG00012
OG00112
OG00213
OG00314
Title
Denominators
Categories
Iron sufficiency maintained
Title
Measurements
OG0007
OG0014
OG0024
OG0039
Iron sufficiency not maintained
Title
Measurements
OG0005
OG0018
OG0029
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
Fisher Exact
0.0895
Superiority
OG001
Fisher Exact
1.000
Superiority
OG002
Fisher Exact
0.3845
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
OG00012
OG00112
OG00213
OG0035
OG0044
OG0055
Title
Denominators
Categories
Iron sufficiency maintained
Title
Measurements
OG0006
OG0012
OG0024
OG0031
OG0041
OG0050
Iron sufficiency not maintained
Title
Measurements
OG0006
OG00110
OG0029
OG003
Units
Counts
Participants
OG00012
OG00112
OG00213
OG0030
Title
Denominators
Categories
Vadadustat
Title
Measurements
OG0005530.9± 4168.86
OG00112955.8± 9771.65
OG00219291.5± 9325.30
O-glucuronide
Title
Measurements
OG0003914.7± 5772.39
OG00112358.6± 7586.73
OG00216586.2± 12363.44
Acyl-glucuronide
Title
Measurements
OG0000.00± 0.000
OG0011.95± 6.755
OG0028.99± 16.430
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
OG00012
OG00112
OG00213
OG00314
Title
Denominators
Categories
TEAEs
Title
Measurements
OG0004
OG0017
OG0027
OG0035
Treatment-emergent SAEs
Title
Measurements
OG0000
OG0010
OG0020
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.