Trial Outcomes & Findings for Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (NCT NCT03054350)

NCT ID: NCT03054350

Last Updated: 2021-04-08

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 60 participants
• Primary outcome timeframe: Pre-treatment; Week 6
• Results posted on: 2021-04-08

Participant Flow

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.

Participant milestones

Measure	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.	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.	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.	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.	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.	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.
Primary Efficacy Period (6 Weeks) STARTED	15	15	15	5	5	5
Primary Efficacy Period (6 Weeks) COMPLETED	11	13	13	3	1	2
Primary Efficacy Period (6 Weeks) NOT COMPLETED	4	2	2	2	4	3
Dose Adjustment and Maintenance Period STARTED	11	13	13	3	1	2
Dose Adjustment and Maintenance Period COMPLETED	10	13	12	2	1	2
Dose Adjustment and Maintenance Period NOT COMPLETED	1	0	1	1	0	0

Reasons for withdrawal

Measure	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.	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.	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.	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.	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.	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.
Primary Efficacy Period (6 Weeks) ESA Rescue/Blood Transfusion for Anemia	4	2	1	2	4	3
Primary Efficacy Period (6 Weeks) Withdrawal by Subject	0	0	1	0	0	0
Dose Adjustment and Maintenance Period ESA Rescue/Blood Transfusion for Anemia	1	0	0	1	0	0
Dose Adjustment and Maintenance Period Captured as Other	0	0	1	0	0	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Vadadustat 150 mg n=15 Participants 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.	Vadadustat 300 mg n=15 Participants 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.	Vadadustat 600 mg n=15 Participants 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.	Placebo to Vadadustat 150 mg n=5 Participants 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.	Placebo to Vadadustat 300 mg n=5 Participants 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.	Placebo to Vadadustat 600 mg n=5 Participants 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.	Total n=60 Participants Total of all reporting groups
Age, Continuous	61.5 years STANDARD_DEVIATION 11.01 • n=15 Participants	64.3 years STANDARD_DEVIATION 8.02 • n=15 Participants	65.1 years STANDARD_DEVIATION 9.05 • n=15 Participants	60.8 years STANDARD_DEVIATION 12.85 • n=5 Participants	61.0 years STANDARD_DEVIATION 15.60 • n=5 Participants	70.8 years STANDARD_DEVIATION 8.23 • n=5 Participants	63.8 years STANDARD_DEVIATION 10.16 • n=60 Participants
Sex: Female, Male Female	5 Participants n=15 Participants	2 Participants n=15 Participants	5 Participants n=15 Participants	2 Participants n=5 Participants	3 Participants n=5 Participants	2 Participants n=5 Participants	19 Participants n=60 Participants
Sex: Female, Male Male	10 Participants n=15 Participants	13 Participants n=15 Participants	10 Participants n=15 Participants	3 Participants n=5 Participants	2 Participants n=5 Participants	3 Participants n=5 Participants	41 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Hemoglobin Levels	8.996 grams per deciliter (g/dL) STANDARD_DEVIATION 0.5229 • n=15 Participants • 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.	8.793 grams per deciliter (g/dL) STANDARD_DEVIATION 0.5254 • n=15 Participants • 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.	9.317 grams per deciliter (g/dL) STANDARD_DEVIATION 0.6222 • n=14 Participants • 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.	8.827 grams per deciliter (g/dL) STANDARD_DEVIATION 0.6405 • n=5 Participants • 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.	8.950 grams per deciliter (g/dL) STANDARD_DEVIATION 0.7331 • n=4 Participants • 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.	9.133 grams per deciliter (g/dL) STANDARD_DEVIATION 0.6737 • n=5 Participants • 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.	9.015 grams per deciliter (g/dL) STANDARD_DEVIATION 0.5935 • n=58 Participants • 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.

PRIMARY outcome

Timeframe: Pre-treatment; Week 6

Population: 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.

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.

Outcome measures

Measure	Vadadustat 150 mg n=15 Participants Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.	Vadadustat 300 mg n=15 Participants Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.	Vadadustat 600 mg n=14 Participants Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.	Placebo n=14 Participants Participants were randomized to receive matching placebo for 6 weeks.	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.	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.
Mean Change in Hemoglobin (Hb) Levels From Pre-treatment to the End of the Primary Efficacy Period	-0.28 grams per deciliter (g/dL) Standard Error 0.218	0.08 grams per deciliter (g/dL) Standard Error 0.222	0.41 grams per deciliter (g/dL) Standard Error 0.233	-1.48 grams per deciliter (g/dL) Standard Error 0.226	—	—

SECONDARY outcome

Timeframe: from Baseline up to Week 16

Population: mITT Population. Only participants with Hb \< 10.0 g/dL at the Baseline visit were included in the analysis.

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.

Outcome measures

Measure	Vadadustat 150 mg n=8 Participants Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.	Vadadustat 300 mg n=12 Participants Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.	Vadadustat 600 mg n=11 Participants Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.	Placebo Participants were randomized to receive matching placebo for 6 weeks.	Placebo to Vadadustat 300 mg n=2 Participants 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.	Placebo to Vadadustat 600 mg n=1 Participants 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.
Time to Reach the Target Hb Level of 10.0 to 12.0 g/dL From Baseline up to Week 16	69.3 days Standard Deviation 25.31	79.2 days Standard Deviation 24.94	54.6 days Standard Deviation 27.90	—	57.0 days Standard Deviation 19.80	85.0 days Standard Deviation NA A standard deviation was not calculated for a single participant.

SECONDARY outcome

Timeframe: up to Week 6

Population: mITT Population. Only participants with available data were analyzed.

Data are reported as mean of the actual Week 6 values.

Outcome measures

Measure	Vadadustat 150 mg n=11 Participants Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.	Vadadustat 300 mg n=13 Participants Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.	Vadadustat 600 mg n=13 Participants Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.	Placebo n=6 Participants Participants were randomized to receive matching placebo for 6 weeks.	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.	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.
Mean Hb Levels at the End of the Primary Efficacy Period	9.064 g/dL Standard Deviation 1.0652	9.062 g/dL Standard Deviation 0.8412	9.969 g/dL Standard Deviation 0.7296	7.817 g/dL Standard Deviation 1.4662	—	—

SECONDARY outcome

Timeframe: up to Week 16

Population: mITT Population. Only participants with available data were analyzed.

Data are reported as mean of the actual Week 16 values.

Outcome measures

Measure	Vadadustat 150 mg n=10 Participants Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.	Vadadustat 300 mg n=13 Participants Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.	Vadadustat 600 mg n=12 Participants Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.	Placebo n=2 Participants Participants were randomized to receive matching placebo for 6 weeks.	Placebo to Vadadustat 300 mg n=1 Participants 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.	Placebo to Vadadustat 600 mg n=2 Participants 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.
Mean Hb Levels at the End of the Dose Adjustment and Maintenance Period	10.460 g/dL Standard Deviation 0.7501	11.285 g/dL Standard Deviation 1.7841	11.100 g/dL Standard Deviation 1.1402	8.600 g/dL Standard Deviation 0.9899	13.200 g/dL Standard Deviation NA A standard deviation was not calculated for a single participant.	12.100 g/dL Standard Deviation 1.5556

SECONDARY outcome

Timeframe: up to Week 16

Population: mITT Population. Only participants with available data were analyzed.

Outcome measures

Measure	Vadadustat 150 mg n=10 Participants Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.	Vadadustat 300 mg n=13 Participants Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.	Vadadustat 600 mg n=12 Participants Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.	Placebo n=2 Participants Participants were randomized to receive matching placebo for 6 weeks.	Placebo to Vadadustat 300 mg n=1 Participants 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.	Placebo to Vadadustat 600 mg n=2 Participants 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.
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	7 Participants	11 Participants	7 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Pre-treatment; Week 16

Population: mITT Population. Only participants with available data were analyzed.

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.

Outcome measures

Measure	Vadadustat 150 mg n=10 Participants Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.	Vadadustat 300 mg n=13 Participants Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.	Vadadustat 600 mg n=12 Participants Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.	Placebo n=2 Participants Participants were randomized to receive matching placebo for 6 weeks.	Placebo to Vadadustat 300 mg n=1 Participants 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.	Placebo to Vadadustat 600 mg n=2 Participants 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.
Mean Change in Hb Between Pre-treatment and the End of the Dose Adjustment and Maintenance Period	1.397 g/dL Standard Deviation 0.5755	2.444 g/dL Standard Deviation 1.7807	1.644 g/dL Standard Deviation 1.4973	-0.233 g/dL Standard Deviation 0.1414	3.800 g/dL Standard Deviation NA A standard deviation was not calculated for a single participant.	3.000 g/dL Standard Deviation 0.2828

SECONDARY outcome

Timeframe: Baseline; Week 6

Population: mITT Population. Only participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Measure	Vadadustat 150 mg n=11 Participants Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.	Vadadustat 300 mg n=13 Participants Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.	Vadadustat 600 mg n=13 Participants Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.	Placebo n=6 Participants Participants were randomized to receive matching placebo for 6 weeks.	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.	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.
Mean Change in Red Blood Cell (RBC) Count and Absolute Reticulocyte Count From Baseline to the End of the Primary Efficacy Period RBC Count	-0.01 10^6 cells/microliter (µL) Standard Error 0.073	0.08 10^6 cells/microliter (µL) Standard Error 0.069	0.20 10^6 cells/microliter (µL) Standard Error 0.069	-0.30 10^6 cells/microliter (µL) Standard Error 0.099	—	—
Mean Change in Red Blood Cell (RBC) Count and Absolute Reticulocyte Count From Baseline to the End of the Primary Efficacy Period Absolute Reticulocyte Count	0.02 10^6 cells/microliter (µL) Standard Error 0.005	0.02 10^6 cells/microliter (µL) Standard Error 0.004	0.03 10^6 cells/microliter (µL) Standard Error 0.004	0.01 10^6 cells/microliter (µL) Standard Error 0.006	—	—

SECONDARY outcome

Timeframe: Baseline; Week 16

Population: mITT Population. Only participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Measure	Vadadustat 150 mg n=10 Participants Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.	Vadadustat 300 mg n=13 Participants Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.	Vadadustat 600 mg n=12 Participants Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.	Placebo n=2 Participants Participants were randomized to receive matching placebo for 6 weeks.	Placebo to Vadadustat 300 mg n=1 Participants 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.	Placebo to Vadadustat 600 mg n=2 Participants 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.
Mean Change in RBC Count and Absolute Reticulocyte Count From Baseline to the End of the Dose Adjustment and Maintenance Period RBC Count	0.454 10^6 cells/µL Standard Deviation 0.2225	0.819 10^6 cells/µL Standard Deviation 0.5127	0.503 10^6 cells/µL Standard Deviation 0.5056	0.065 10^6 cells/µL Standard Deviation 0.0212	1.160 10^6 cells/µL Standard Deviation NA A standard deviation was not calculated for a single participant.	1.035 10^6 cells/µL Standard Deviation 0.0778
Mean Change in RBC Count and Absolute Reticulocyte Count From Baseline to the End of the Dose Adjustment and Maintenance Period Absolute Reticulocyte Count	0.017 10^6 cells/µL Standard Deviation 0.0169	0.021 10^6 cells/µL Standard Deviation 0.0180	0.016 10^6 cells/µL Standard Deviation 0.0162	0.016 10^6 cells/µL Standard Deviation 0.0083	0.024 10^6 cells/µL Standard Deviation NA A standard deviation was not calculated for a single participant.	0.014 10^6 cells/µL Standard Deviation 0.0217

SECONDARY outcome

Timeframe: Baseline; Week 6

Population: mITT Population. Only participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Measure	Vadadustat 150 mg n=11 Participants Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.	Vadadustat 300 mg n=13 Participants Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.	Vadadustat 600 mg n=13 Participants Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.	Placebo n=6 Participants Participants were randomized to receive matching placebo for 6 weeks.	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.	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.
Mean Change in Hematocrit and Reticulocytes From Baseline to the End of the Primary Efficacy Period Hematocrit	0.67 percentage Standard Error 0.770	1.98 percentage Standard Error 0.737	3.30 percentage Standard Error 0.737	-2.63 percentage Standard Error 1.045	—	—
Mean Change in Hematocrit and Reticulocytes From Baseline to the End of the Primary Efficacy Period Reticulocytes	0.64 percentage Standard Error 0.158	0.57 percentage Standard Error 0.141	0.71 percentage Standard Error 0.140	0.39 percentage Standard Error 0.212	—	—

SECONDARY outcome

Timeframe: Baseline; Week 16

Population: mITT Population. Only participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Measure	Vadadustat 150 mg n=10 Participants Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.	Vadadustat 300 mg n=13 Participants Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.	Vadadustat 600 mg n=12 Participants Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.	Placebo n=2 Participants Participants were randomized to receive matching placebo for 6 weeks.	Placebo to Vadadustat 300 mg n=1 Participants 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.	Placebo to Vadadustat 600 mg n=2 Participants 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.
Mean Change in Hematocrit and Reticulocytes From Baseline to the End of the Dose Adjustment and Maintenance Period Hematocrit	5.12 percentage Standard Deviation 2.105	8.92 percentage Standard Deviation 5.100	5.63 percentage Standard Deviation 4.921	1.20 percentage Standard Deviation 0.000	12.90 percentage Standard Deviation NA A standard deviation was not calculated for a single participant.	10.70 percentage Standard Deviation 1.697
Mean Change in Hematocrit and Reticulocytes From Baseline to the End of the Dose Adjustment and Maintenance Period Reticulocytes	0.32 percentage Standard Deviation 0.636	0.33 percentage Standard Deviation 0.686	0.24 percentage Standard Deviation 0.547	0.55 percentage Standard Deviation 0.212	0.40 percentage Standard Deviation NA A standard deviation was not calculated for a single participant.	0.15 percentage Standard Deviation 0.636

SECONDARY outcome

Timeframe: Baseline; Week 6

Population: mITT Population. Only participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Measure	Vadadustat 150 mg n=11 Participants Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.	Vadadustat 300 mg n=13 Participants Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.	Vadadustat 600 mg n=13 Participants Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.	Placebo n=6 Participants Participants were randomized to receive matching placebo for 6 weeks.	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.	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.
Mean Change in Iron and Total Iron Binding Capacity (TIBC) From Baseline to the End of the Primary Efficacy Period Iron	-3.3 micrograms per deciliter (μg/dL) Standard Deviation 26.60	-1.5 micrograms per deciliter (μg/dL) Standard Deviation 19.50	-8.1 micrograms per deciliter (μg/dL) Standard Deviation 21.95	-1.5 micrograms per deciliter (μg/dL) Standard Deviation 26.64	—	—
Mean Change in Iron and Total Iron Binding Capacity (TIBC) From Baseline to the End of the Primary Efficacy Period TIBC	35.4 micrograms per deciliter (μg/dL) Standard Deviation 28.72	67.5 micrograms per deciliter (μg/dL) Standard Deviation 25.72	80.7 micrograms per deciliter (μg/dL) Standard Deviation 39.04	15.8 micrograms per deciliter (μg/dL) Standard Deviation 8.08	—	—

SECONDARY outcome

Timeframe: Baseline; Week 16

Population: mITT Population. Only participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Measure	Vadadustat 150 mg n=10 Participants Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.	Vadadustat 300 mg n=13 Participants Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.	Vadadustat 600 mg n=12 Participants Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.	Placebo n=2 Participants Participants were randomized to receive matching placebo for 6 weeks.	Placebo to Vadadustat 300 mg n=1 Participants 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.	Placebo to Vadadustat 600 mg n=2 Participants 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.
Mean Change in Iron and TIBC From Baseline to the End of the Dose Adjustment and Maintenance Period TIBC	58.5 μg/dL Standard Deviation 44.12	80.9 μg/dL Standard Deviation 29.42	85.4 μg/dL Standard Deviation 39.91	33.0 μg/dL Standard Deviation 2.83	108.0 μg/dL Standard Deviation NA A standard deviation was not calculated for a single participant.	78.0 μg/dL Standard Deviation 62.23
Mean Change in Iron and TIBC From Baseline to the End of the Dose Adjustment and Maintenance Period Iron	-18.5 μg/dL Standard Deviation 24.01	-8.7 μg/dL Standard Deviation 24.29	0.9 μg/dL Standard Deviation 48.22	-9.5 μg/dL Standard Deviation 30.41	-7.0 μg/dL Standard Deviation NA A standard deviation was not calculated for a single participant.	15.0 μg/dL Standard Deviation 43.84

SECONDARY outcome

Timeframe: Baseline; Week 6

Population: mITT Population. Only participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Measure	Vadadustat 150 mg n=11 Participants Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.	Vadadustat 300 mg n=13 Participants Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.	Vadadustat 600 mg n=13 Participants Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.	Placebo n=6 Participants Participants were randomized to receive matching placebo for 6 weeks.	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.	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.
Mean Change in Transferrin Saturation (TSAT) From Baseline to the End of the Primary Efficacy Period	-6.51 percentage Standard Deviation 11.621	-10.14 percentage Standard Deviation 11.294	-12.46 percentage Standard Deviation 9.544	-2.78 percentage Standard Deviation 12.822	—	—

SECONDARY outcome

Timeframe: Baseline; Week 16

Population: mITT Population. Only participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Measure	Vadadustat 150 mg n=10 Participants Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.	Vadadustat 300 mg n=13 Participants Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.	Vadadustat 600 mg n=12 Participants Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.	Placebo n=2 Participants Participants were randomized to receive matching placebo for 6 weeks.	Placebo to Vadadustat 300 mg n=1 Participants 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.	Placebo to Vadadustat 600 mg n=2 Participants 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.
Mean Change in TSAT From Baseline to the End of the Dose Adjustment and Maintenance Period	-14.25 percentage Standard Deviation 12.069	-13.79 percentage Standard Deviation 13.549	-10.93 percentage Standard Deviation 12.627	-12.50 percentage Standard Deviation 18.526	-17.10 percentage Standard Deviation NA A standard deviation was not calculated for a single participant.	-4.70 percentage Standard Deviation 12.021

SECONDARY outcome

Timeframe: Baseline; Week 6

Population: mITT Population. Only participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Measure	Vadadustat 150 mg n=11 Participants Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.	Vadadustat 300 mg n=13 Participants Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.	Vadadustat 600 mg n=13 Participants Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.	Placebo n=6 Participants Participants were randomized to receive matching placebo for 6 weeks.	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.	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.
Mean Change in Ferritin and Hepcidin From Baseline to the End of the Primary Efficacy Period Ferritin	-51.20 nanograms per milliliter (ng/mL) Standard Deviation 58.855	-68.67 nanograms per milliliter (ng/mL) Standard Deviation 54.707	-104.49 nanograms per milliliter (ng/mL) Standard Deviation 49.558	12.63 nanograms per milliliter (ng/mL) Standard Deviation 32.424	—	—
Mean Change in Ferritin and Hepcidin From Baseline to the End of the Primary Efficacy Period Hepcidin	-53.465 nanograms per milliliter (ng/mL) Standard Deviation 43.5531	-73.587 nanograms per milliliter (ng/mL) Standard Deviation 32.3547	-104.301 nanograms per milliliter (ng/mL) Standard Deviation 36.7636	-11.802 nanograms per milliliter (ng/mL) Standard Deviation 13.6518	—	—

SECONDARY outcome

Timeframe: Baseline; Week 16

Population: mITT Population. Only participants with available data were analyzed.

Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Outcome measures

Measure	Vadadustat 150 mg n=10 Participants Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.	Vadadustat 300 mg n=13 Participants Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.	Vadadustat 600 mg n=12 Participants Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.	Placebo n=2 Participants Participants were randomized to receive matching placebo for 6 weeks.	Placebo to Vadadustat 300 mg n=1 Participants 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.	Placebo to Vadadustat 600 mg n=2 Participants 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.
Mean Change in Ferritin and Hepcidin From Baseline to the End of the Dose Adjustment and Maintenance Period Hepcidin	-73.826 ng/mL Standard Deviation 50.9042	-99.367 ng/mL Standard Deviation 51.3174	-106.838 ng/mL Standard Deviation 40.1472	-95.940 ng/mL Standard Deviation 98.7262	-122.300 ng/mL Standard Deviation NA A standard deviation was not calculated for a single participant.	-35.140 ng/mL Standard Deviation 62.9184
Mean Change in Ferritin and Hepcidin From Baseline to the End of the Dose Adjustment and Maintenance Period Ferritin	-105.09 ng/mL Standard Deviation 55.837	-119.28 ng/mL Standard Deviation 84.000	-113.52 ng/mL Standard Deviation 54.559	-43.05 ng/mL Standard Deviation 81.954	-150.70 ng/mL Standard Deviation NA A standard deviation was not calculated for a single participant.	-76.95 ng/mL Standard Deviation 42.356

SECONDARY outcome

Timeframe: Baseline; Week 6

Population: mITT Population. Only participants with available data were analyzed.

Participants who initiated rescue therapy (including RBC transfusion) were required to stop study drug treatment and were discontinued from the study.

Outcome measures

Measure	Vadadustat 150 mg n=15 Participants Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.	Vadadustat 300 mg n=15 Participants Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.	Vadadustat 600 mg n=14 Participants Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.	Placebo n=14 Participants Participants were randomized to receive matching placebo for 6 weeks.	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.	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.
Number of Participants Who Required Rescue With a RBC Transfusion From Baseline to the End of the Primary Efficacy Period	0 Participants	0 Participants	1 Participants	3 Participants	—	—

SECONDARY outcome

Timeframe: Baseline; Week 16

Population: mITT Population. Only participants with available data were analyzed.

Participants who initiated rescue therapy (including RBC transfusion) were required to stop study drug treatment and were discontinued from the study.

Outcome measures

Measure	Vadadustat 150 mg n=15 Participants Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.	Vadadustat 300 mg n=15 Participants Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.	Vadadustat 600 mg n=14 Participants Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.	Placebo n=5 Participants Participants were randomized to receive matching placebo for 6 weeks.	Placebo to Vadadustat 300 mg n=4 Participants 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.	Placebo to Vadadustat 600 mg n=5 Participants 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.
Number of Participants Who Required Rescue With RBC Transfusion From Baseline to the End of the Dose Adjustment and Maintenance Period	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline; Week 6

Population: mITT Population. Only participants with available data were analyzed.

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.

Outcome measures

Measure	Vadadustat 150 mg n=15 Participants Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.	Vadadustat 300 mg n=15 Participants Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.	Vadadustat 600 mg n=14 Participants Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.	Placebo n=14 Participants Participants were randomized to receive matching placebo for 6 weeks.	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.	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.
Number of Participants Who Required Rescue With Erythropoiesis-Stimulating Agents (ESAs) From Baseline to the End of the Primary Efficacy Period	4 Participants	2 Participants	1 Participants	8 Participants	—	—

SECONDARY outcome

Timeframe: Baseline; Week 16

Population: mITT Population. Only participants with available data were analyzed.

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.

Outcome measures

Measure	Vadadustat 150 mg n=15 Participants Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.	Vadadustat 300 mg n=15 Participants Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.	Vadadustat 600 mg n=14 Participants Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.	Placebo n=5 Participants Participants were randomized to receive matching placebo for 6 weeks.	Placebo to Vadadustat 300 mg n=4 Participants 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.	Placebo to Vadadustat 600 mg n=5 Participants 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.
Number of Participants Who Required Rescue With ESAs From Baseline to the End of the Dose Adjustment and Maintenance Period	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: up to Week 16

Population: mITT Population

Increases in dose were not allowed during the 6-week Primary Efficacy Period.

Outcome measures

Measure	Vadadustat 150 mg n=15 Participants Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.	Vadadustat 300 mg n=15 Participants Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.	Vadadustat 600 mg n=14 Participants Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.	Placebo n=5 Participants Participants were randomized to receive matching placebo for 6 weeks.	Placebo to Vadadustat 300 mg n=4 Participants 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.	Placebo to Vadadustat 600 mg n=5 Participants 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.
Number of the Participants With the Indicated Number of Dose Adjustments From Baseline to the End of the Dose Adjustment and Maintenance Period 0 dose adjustments	5 Participants	3 Participants	9 Participants	2 Participants	3 Participants	3 Participants
Number of the Participants With the Indicated Number of Dose Adjustments From Baseline to the End of the Dose Adjustment and Maintenance Period 1 dose adjustment	2 Participants	2 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Number of the Participants With the Indicated Number of Dose Adjustments From Baseline to the End of the Dose Adjustment and Maintenance Period 2 dose adjustments	5 Participants	8 Participants	3 Participants	1 Participants	1 Participants	2 Participants
Number of the Participants With the Indicated Number of Dose Adjustments From Baseline to the End of the Dose Adjustment and Maintenance Period 3 or more dose adjustments	3 Participants	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 4, pre-dose

Population: 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

Blood samples were collected for analysis.

Outcome measures

Measure	Vadadustat 150 mg n=12 Participants Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.	Vadadustat 300 mg n=13 Participants Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.	Vadadustat 600 mg n=13 Participants Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.	Placebo Participants were randomized to receive matching placebo for 6 weeks.	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.	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.
Plasma Concentration Profile of Vadadustat and Its Metabolites Using a Pre-dose Sample From Week 4 Vadadustat	4343.54 μg/mL Geometric Coefficient of Variation 175.17	7561.36 μg/mL Geometric Coefficient of Variation 134.77	15083.03 μg/mL Geometric Coefficient of Variation 46.77	—	—	—
Plasma Concentration Profile of Vadadustat and Its Metabolites Using a Pre-dose Sample From Week 4 O-glucuronide	8667.97 μg/mL Geometric Coefficient of Variation 73.79	14623.89 μg/mL Geometric Coefficient of Variation 67.44	36476.33 μg/mL Geometric Coefficient of Variation 57.18	—	—	—
Plasma Concentration Profile of Vadadustat and Its Metabolites Using a Pre-dose Sample From Week 4 Acyl-glucuronide	12.019 μg/mL Geometric Coefficient of Variation 16.55	12.174 μg/mL Geometric Coefficient of Variation 8.10	22.765 μg/mL Geometric Coefficient of Variation 70.53	—	—	—

SECONDARY outcome

Timeframe: up to Week 6

Population: 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

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.

Outcome measures

Measure	Vadadustat 150 mg n=15 Participants Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.	Vadadustat 300 mg n=15 Participants Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.	Vadadustat 600 mg n=15 Participants Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.	Placebo n=15 Participants Participants were randomized to receive matching placebo for 6 weeks.	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.	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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs) in the Primary Efficacy Period TEAEs	8 Participants	11 Participants	6 Participants	6 Participants	—	—
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs) in the Primary Efficacy Period Treatment-emergent SAEs	0 Participants	0 Participants	3 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: up to Week 16

Population: Safety Population

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.

Outcome measures

Measure	Vadadustat 150 mg n=15 Participants Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.	Vadadustat 300 mg n=15 Participants Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.	Vadadustat 600 mg n=15 Participants Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.	Placebo n=5 Participants Participants were randomized to receive matching placebo for 6 weeks.	Placebo to Vadadustat 300 mg n=5 Participants 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.	Placebo to Vadadustat 600 mg n=5 Participants 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.
Number of Participants With TEAEs and Treatment-emergent SAEs in the Dose Adjustment and Maintenance Period TEAEs	9 Participants	9 Participants	9 Participants	1 Participants	1 Participants	2 Participants
Number of Participants With TEAEs and Treatment-emergent SAEs in the Dose Adjustment and Maintenance Period Treatment-emergent SAEs	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Dose Adjustment and Maintenance: 300 mg Vadadustat

Serious events: 1 serious events

Other events: 9 other events

Deaths: 9 deaths

Dose Adjustment and Maintenance: 600 mg Vadadustat

Serious events: 1 serious events

Other events: 9 other events

Deaths: 9 deaths

Primary Efficacy Period: 150 mg Vadadustat

Serious events: 0 serious events

Other events: 8 other events

Deaths: 8 deaths

Primary Efficacy Period: 300 mg Vadadustat

Serious events: 0 serious events

Other events: 11 other events

Deaths: 11 deaths

Primary Efficacy Period: 600 mg Vadadustat

Serious events: 3 serious events

Other events: 5 other events

Deaths: 6 deaths

Primary Efficacy Period: Placebo Matched to 150 mg Vadadustat

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

Primary Efficacy Period: Placebo Matched to 300 mg Vadadustat

Serious events: 1 serious events

Other events: 2 other events

Deaths: 2 deaths

Primary Efficacy Period: Placebo Matched to 600 mg Vadadustat

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

Dose Adjustment and Maintenance: 150 mg Vadadustat

Serious events: 1 serious events

Other events: 9 other events

Deaths: 9 deaths

Dose Adjustment and Maintenance: Placebo to 150 mg Vadadustat

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Dose Adjustment and Maintenance: Placebo to 300 mg Vadadustat

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Dose Adjustment and Maintenance: Placebo to 600 mg Vadadustat

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

Serious adverse events

Measure	Dose Adjustment and Maintenance: 300 mg Vadadustat n=15 participants at risk 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.	Dose Adjustment and Maintenance: 600 mg Vadadustat n=15 participants at risk 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.	Primary Efficacy Period: 150 mg Vadadustat n=15 participants at risk Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.	Primary Efficacy Period: 300 mg Vadadustat n=15 participants at risk Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.	Primary Efficacy Period: 600 mg Vadadustat n=15 participants at risk Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.	Primary Efficacy Period: Placebo Matched to 150 mg Vadadustat n=5 participants at risk Participants were randomized to receive matching placebo for 6 weeks.	Primary Efficacy Period: Placebo Matched to 300 mg Vadadustat n=5 participants at risk Participants were randomized to receive matching placebo for 6 weeks.	Primary Efficacy Period: Placebo Matched to 600 mg Vadadustat n=5 participants at risk Participants were randomized to receive matching placebo for 6 weeks.	Dose Adjustment and Maintenance: 150 mg Vadadustat n=15 participants at risk 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.	Dose Adjustment and Maintenance: Placebo to 150 mg Vadadustat n=5 participants at risk 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.	Dose Adjustment and Maintenance: Placebo to 300 mg Vadadustat n=5 participants at risk 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.	Dose Adjustment and Maintenance: Placebo to 600 mg Vadadustat n=5 participants at risk 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.
Cardiac disorders Pericarditis	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Hepatobiliary disorders Cholecystitis acute	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Infections and infestations Enteritis infectious	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Injury, poisoning and procedural complications Arteriovenous fistula site complication	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	20.0% 1/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Injury, poisoning and procedural complications Shunt stenosis	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Nervous system disorders Cerebral haemorrhage	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Nervous system disorders Toxic encephalopathy	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Psychiatric disorders Anxiety	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18

Other adverse events

Measure	Dose Adjustment and Maintenance: 300 mg Vadadustat n=15 participants at risk 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.	Dose Adjustment and Maintenance: 600 mg Vadadustat n=15 participants at risk 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.	Primary Efficacy Period: 150 mg Vadadustat n=15 participants at risk Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.	Primary Efficacy Period: 300 mg Vadadustat n=15 participants at risk Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.	Primary Efficacy Period: 600 mg Vadadustat n=15 participants at risk Participants were randomized to receive vadadustat 600 mg, administered as 4 tablets QD, for 6 weeks.	Primary Efficacy Period: Placebo Matched to 150 mg Vadadustat n=5 participants at risk Participants were randomized to receive matching placebo for 6 weeks.	Primary Efficacy Period: Placebo Matched to 300 mg Vadadustat n=5 participants at risk Participants were randomized to receive matching placebo for 6 weeks.	Primary Efficacy Period: Placebo Matched to 600 mg Vadadustat n=5 participants at risk Participants were randomized to receive matching placebo for 6 weeks.	Dose Adjustment and Maintenance: 150 mg Vadadustat n=15 participants at risk 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.	Dose Adjustment and Maintenance: Placebo to 150 mg Vadadustat n=5 participants at risk 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.	Dose Adjustment and Maintenance: Placebo to 300 mg Vadadustat n=5 participants at risk 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.	Dose Adjustment and Maintenance: Placebo to 600 mg Vadadustat n=5 participants at risk 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.
Investigations Blood pressure increased	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Investigations Blood uric acid decreased	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	20.0% 1/5 • up to Week 18	0.00% 0/5 • up to Week 18
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Injury, poisoning and procedural complications Thermal burn	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Injury, poisoning and procedural complications Vascular graft stenosis	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Gastrointestinal disorders Abdominal pain	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Gastrointestinal disorders Constipation	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Gastrointestinal disorders Diarrhoea	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	13.3% 2/15 • up to Week 18	13.3% 2/15 • up to Week 18	20.0% 1/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	20.0% 1/5 • up to Week 18	0.00% 0/5 • up to Week 18	20.0% 1/5 • up to Week 18
Gastrointestinal disorders Faeces soft	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Gastrointestinal disorders Nausea	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Gastrointestinal disorders Pancreatic cyst	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	20.0% 1/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
General disorders Chest discomfort	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	20.0% 1/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
General disorders Pyrexia	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Infections and infestations Bronchitis	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Infections and infestations Herpes zoster	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	20.0% 1/5 • up to Week 18
Infections and infestations Nasopharyngitis	13.3% 2/15 • up to Week 18	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	33.3% 5/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	26.7% 4/15 • up to Week 18	0.00% 0/5 • up to Week 18	20.0% 1/5 • up to Week 18	0.00% 0/5 • up to Week 18
Infections and infestations Pneumonia	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	20.0% 1/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Infections and infestations Tracheobronchitis	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Infections and infestations Upper respiratory tract infection	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Injury, poisoning and procedural complications Contusion	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/5 • up to Week 18	20.0% 1/5 • up to Week 18	0.00% 0/5 • up to Week 18	13.3% 2/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Injury, poisoning and procedural complications Excoriation	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	20.0% 1/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Injury, poisoning and procedural complications Foreign body	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Injury, poisoning and procedural complications Shunt stenosis	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Investigations Blood parathyroid hormone increased	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	20.0% 1/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	20.0% 1/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	20.0% 1/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Nervous system disorders Headache	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	13.3% 2/15 • up to Week 18	20.0% 1/5 • up to Week 18	0.00% 0/5 • up to Week 18	20.0% 1/5 • up to Week 18
Psychiatric disorders Insomnia	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	20.0% 1/5 • up to Week 18	0.00% 0/5 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Respiratory, thoracic and mediastinal disorders Cough	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Skin and subcutaneous tissue disorders Neurodermatitis	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	20.0% 1/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Blood and lymphatic system disorders Anaemia macrocytic	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Gastrointestinal disorders Enterocolitis	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Gastrointestinal disorders Stomatitis	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Gastrointestinal disorders Vomiting	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
General disorders Catheter site erosion	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	20.0% 1/5 • up to Week 18
General disorders Vessel puncture site pruritus	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	20.0% 1/5 • up to Week 18
Hepatobiliary disorders Cholelithiasis	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Infections and infestations Conjunctivitis	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	20.0% 1/5 • up to Week 18
Infections and infestations Gingivitis	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Infections and infestations Periodontitis	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Injury, poisoning and procedural complications Arteriovenous fistula site complication	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Nervous system disorders Diabetic neuropathy	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Nervous system disorders Post herpetic neuralgia	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Nervous system disorders Restless legs syndrome	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Respiratory, thoracic and mediastinal disorders Asthma	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Skin and subcutaneous tissue disorders Eczema	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	20.0% 1/5 • up to Week 18
Skin and subcutaneous tissue disorders Ingrowing nail	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Skin and subcutaneous tissue disorders Rash pruritic	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Vascular disorders Haemorrhage	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	20.0% 1/5 • up to Week 18
Cardiac disorders Cardiac failure chronic	0.00% 0/15 • up to Week 18	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18
Eye disorders Diabetic retinopathy	6.7% 1/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/15 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/5 • up to Week 18

Additional Information

Akebia Therapeutics

Akebia Therapeutics

Phone: (617) 844-6128

Email: trials@akebia.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER