Trial Outcomes & Findings for Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD) (NCT NCT03054337)

NCT ID: NCT03054337

Last Updated: 2021-04-08

Results Overview

The pre-treatment value for Hb was defined as the average of 2 values obtained prior to treatment, i.e., the qualifying screening value and the Baseline value. Change from Pre-treatment was calculated as the Week 6 value minus the Pre-treatment value.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 51 participants
• Primary outcome timeframe: Pre-treatment; Week 6
• Results posted on: 2021-04-08

Participant Flow

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

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.
Dose Adjustment and Maintenance Period Investigator discretion	1	2	1	0	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

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 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=12 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=13 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=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.	Total n=51 Participants Total of all reporting groups
Age, Continuous	71.9 years STANDARD_DEVIATION 10.33 • n=12 Participants	65.8 years STANDARD_DEVIATION 11.53 • n=12 Participants	71.5 years STANDARD_DEVIATION 12.84 • n=13 Participants	73.4 years STANDARD_DEVIATION 3.05 • n=5 Participants	68.0 years STANDARD_DEVIATION 21.21 • n=4 Participants	72.2 years STANDARD_DEVIATION 8.64 • n=5 Participants	70.2 years STANDARD_DEVIATION 11.55 • n=51 Participants
Sex: Female, Male Female	5 Participants n=12 Participants	5 Participants n=12 Participants	8 Participants n=13 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=5 Participants	22 Participants n=51 Participants
Sex: Female, Male Male	7 Participants n=12 Participants	7 Participants n=12 Participants	5 Participants n=13 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=5 Participants	29 Participants n=51 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Hemoglobin Levels	9.958 grams per deciliter (g/dL) STANDARD_DEVIATION 0.8051 • n=12 Participants	9.492 grams per deciliter (g/dL) STANDARD_DEVIATION 0.8867 • n=12 Participants	9.500 grams per deciliter (g/dL) STANDARD_DEVIATION 0.8446 • n=13 Participants	10.280 grams per deciliter (g/dL) STANDARD_DEVIATION 0.9365 • n=5 Participants	9.625 grams per deciliter (g/dL) STANDARD_DEVIATION 0.6551 • n=4 Participants	9.680 grams per deciliter (g/dL) STANDARD_DEVIATION 0.8198 • n=5 Participants	9.710 grams per deciliter (g/dL) STANDARD_DEVIATION 0.8410 • n=51 Participants

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 value for Hb was defined as the average of 2 values obtained prior to treatment, i.e., the qualifying screening value and the Baseline value. Change from Pre-treatment was calculated as the Week 6 value minus the Pre-treatment value.

Outcome measures

Measure	Vadadustat 150 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=12 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=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	0.43 grams per deciliter (g/dL) Standard Error 0.224	1.13 grams per deciliter (g/dL) Standard Error 0.223	1.62 grams per deciliter (g/dL) Standard Error 0.215	-0.47 grams per deciliter (g/dL) Standard Error 0.206	—	—

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 n=6 Participants Participants were randomized to receive vadadustat 150 milligrams (mg), administered as 1 tablet once daily (QD), for 6 weeks.	Vadadustat 300 mg n=7 Participants Participants were randomized to receive vadadustat 300 mg, administered as 2 tablets QD, for 6 weeks.	Vadadustat 600 mg n=8 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=3 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=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 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	56.8 days Standard Deviation 43.31	39.0 days Standard Deviation 38.52	25.6 days Standard Deviation 16.47	79.0 days Standard Deviation 11.31	71.0 days Standard Deviation 14.00	54.5 days Standard Deviation 33.67

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 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=12 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=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 Hb Levels at the End of the Primary Efficacy Period	10.392 g/dL Standard Deviation 0.7280	10.675 g/dL Standard Deviation 1.2693	11.162 g/dL Standard Deviation 1.1169	9.421 g/dL Standard Deviation 0.9242	—	—

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 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=10 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=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=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 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	10.973 g/dL Standard Deviation 0.5711	11.230 g/dL Standard Deviation 0.7514	11.342 g/dL Standard Deviation 0.6473	10.860 g/dL Standard Deviation 0.5857	11.425 g/dL Standard Deviation 0.9179	11.950 g/dL Standard Deviation 0.6608

SECONDARY outcome

Timeframe: up to Week 16

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

Outcome measures

Measure	Vadadustat 150 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=10 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=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=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 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	11 Participants	8 Participants	11 Participants	5 Participants	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Pre-treatment; Week 16

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

The pre-treatment value for Hb was defined as the average of 2 values obtained prior to treatment, i.e., the qualifying screening value and the Baseline value. Change from Pre-treatment was calculated as the Week 16 value minus the Pre-treatment value.

Outcome measures

Measure	Vadadustat 150 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=10 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=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=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 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	0.982 g/dL Standard Deviation 0.3676	1.610 g/dL Standard Deviation 1.1692	1.779 g/dL Standard Deviation 0.8117	0.790 g/dL Standard Deviation 0.3070	1.538 g/dL Standard Deviation 0.5250	2.075 g/dL Standard Deviation 0.2784

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 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=12 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=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 Red Blood Cell (RBC) Count and Absolute Reticulocyte Count From Baseline to the End of the Primary Efficacy Period RBC Count	0.17 10^6 cells/microliter (μL) Standard Error 0.075	0.34 10^6 cells/microliter (μL) Standard Error 0.075	0.48 10^6 cells/microliter (μL) Standard Error 0.073	-0.17 10^6 cells/microliter (μL) Standard Error 0.070	—	—
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	0.01 10^6 cells/microliter (μL) Standard Error 0.004	0.01 10^6 cells/microliter (μL) Standard Error 0.003	0.01 10^6 cells/microliter (μL) Standard Error 0.003	0.01 10^6 cells/microliter (μL) Standard Error 0.003	—	—

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 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=10 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=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=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 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	0.305 10^6 cells/μL Standard Deviation 0.1870	0.476 10^6 cells/μL Standard Deviation 0.4406	0.593 10^6 cells/μL Standard Deviation 0.3186	0.186 10^6 cells/μL Standard Deviation 0.2165	0.438 10^6 cells/μL Standard Deviation 0.2175	0.608 10^6 cells/μL Standard Deviation 0.1771
Mean Change in RBC Count and Absolute Reticulocyte Count From Baseline to the End of the Dose Adjustment and Maintenance Period Absolute Reticulocyte Count	0.003078 10^6 cells/μL Standard Deviation 0.0094008	0.008001 10^6 cells/μL Standard Deviation 0.0156884	0.000196 10^6 cells/μL Standard Deviation 0.0085029	0.010716 10^6 cells/μL Standard Deviation 0.0279909	0.009703 10^6 cells/μL Standard Deviation 0.0103348	0.000595 10^6 cells/μL Standard Deviation 0.0171563

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 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=12 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=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 Hematocrit and Reticulocytes From Baseline to the End of the Primary Efficacy Period Hematocrit	2.13 percentage Standard Error 0.696	4.13 percentage Standard Error 0.696	6.07 percentage Standard Error 0.667	-1.17 percentage Standard Error 0.643	—	—
Mean Change in Hematocrit and Reticulocytes From Baseline to the End of the Primary Efficacy Period Reticulocytes	0.16 percentage Standard Error 0.111	0.28 percentage Standard Error 0.111	0.19 percentage Standard Error 0.107	0.25 percentage Standard Error 0.103	—	—

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 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=10 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=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=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 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	3.28 percentage Standard Deviation 1.947	5.17 percentage Standard Deviation 4.991	5.39 percentage Standard Deviation 2.844	2.32 percentage Standard Deviation 1.827	5.80 percentage Standard Deviation 1.566	6.05 percentage Standard Deviation 1.997
Mean Change in Hematocrit and Reticulocytes From Baseline to the End of the Dose Adjustment and Maintenance Period Reticulocytes	-0.02 percentage Standard Deviation 0.232	0.07 percentage Standard Deviation 0.442	-0.18 percentage Standard Deviation 0.279	0.28 percentage Standard Deviation 0.893	0.15 percentage Standard Deviation 0.238	-0.18 percentage Standard Deviation 0.377

SECONDARY outcome

Timeframe: Baseline; Week 6

Population: mITT Population

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

Outcome measures

Measure	Vadadustat 150 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=12 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=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 Iron and Total Iron Binding Capacity (TIBC) From Baseline to the End of the Primary Efficacy Period Iron	-1.8 micrograms per deciliter (μg/dL) Standard Deviation 19.58	-2.4 micrograms per deciliter (μg/dL) Standard Deviation 20.75	4.4 micrograms per deciliter (μg/dL) Standard Deviation 30.82	-7.4 micrograms per deciliter (μg/dL) Standard Deviation 19.92	—	—
Mean Change in Iron and Total Iron Binding Capacity (TIBC) From Baseline to the End of the Primary Efficacy Period TIBC	44.9 micrograms per deciliter (μg/dL) Standard Deviation 32.9	75.2 micrograms per deciliter (μg/dL) Standard Deviation 35.60	93.8 micrograms per deciliter (μg/dL) Standard Deviation 44.74	7.6 micrograms per deciliter (μg/dL) Standard Deviation 23.55	—	—

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 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=10 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=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=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 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 Iron	11.7 μg/dL Standard Deviation 38.25	3.5 μg/dL Standard Deviation 31.17	11.5 μg/dL Standard Deviation 28.56	-1.4 μg/dL Standard Deviation 21.82	5.5 μg/dL Standard Deviation 24.66	5.8 μg/dL Standard Deviation 25.59
Mean Change in Iron and TIBC From Baseline to the End of the Dose Adjustment and Maintenance Period TIBC	51.8 μg/dL Standard Deviation 48.41	43.4 μg/dL Standard Deviation 42.77	42.8 μg/dL Standard Deviation 28.28	47.6 μg/dL Standard Deviation 21.71	73.5 μg/dL Standard Deviation 39.95	44.5 μg/dL Standard Deviation 43.19

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 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=12 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=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 Transferrin Saturation (TSAT) From Baseline to the End of the Primary Efficacy Period	-4.96 percentage Standard Deviation 7.343	-7.31 percentage Standard Deviation 8.380	-6.78 percentage Standard Deviation 10.609	-4.72 percentage Standard Deviation 8.931	—	—

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 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=10 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=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=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 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	-1.47 percentage Standard Deviation 10.365	-2.68 percentage Standard Deviation 13.201	-0.19 percentage Standard Deviation 9.857	-7.00 percentage Standard Deviation 12.247	-5.03 percentage Standard Deviation 11.342	-2.68 percentage Standard Deviation 10.608

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 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=12 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=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 Ferritin and Hepcidin From Baseline to the End of the Primary Efficacy Period Ferritin	-38.48 nanograms per milliliter (ng/mL) Standard Deviation 34.227	-69.36 nanograms per milliliter (ng/mL) Standard Deviation 49.965	-101.54 nanograms per milliliter (ng/mL) Standard Deviation 57.697	-11.44 nanograms per milliliter (ng/mL) Standard Deviation 31.408	—	—
Mean Change in Ferritin and Hepcidin From Baseline to the End of the Primary Efficacy Period Hepcidin	-24.622 nanograms per milliliter (ng/mL) Standard Deviation 20.0165	-40.819 nanograms per milliliter (ng/mL) Standard Deviation 27.2486	-37.964 nanograms per milliliter (ng/mL) Standard Deviation 21.0819	-3.824 nanograms per milliliter (ng/mL) Standard Deviation 18.4986	—	—

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 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=10 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=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=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 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 Ferritin	-79.45 ng/mL Standard Deviation 39.655	-62.35 ng/mL Standard Deviation 36.808	-59.68 ng/mL Standard Deviation 59.843	-69.26 ng/mL Standard Deviation 46.519	-146.63 ng/mL Standard Deviation 34.261	-59.43 ng/mL Standard Deviation 13.618
Mean Change in Ferritin and Hepcidin From Baseline to the End of the Dose Adjustment and Maintenance Period Hepcidin	-29.522 ng/mL Standard Deviation 22.7101	-23.061 ng/mL Standard Deviation 53.0161	-2.502 ng/mL Standard Deviation 21.2660	-9.464 ng/mL Standard Deviation 19.1361	-38.920 ng/mL Standard Deviation 23.4788	-9.745 ng/mL Standard Deviation 9.2100

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 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=12 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=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	0 Participants	0 Participants	0 Participants	0 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 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=12 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=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	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline; Week 6

Population: mITT Population. Only participant 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 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=12 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=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	0 Participants	0 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 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=12 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=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 a RBC Transfusion From Baseline to the End of the Dose Adjustment and Maintenance Period	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline to Week 16

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

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

Outcome measures

Measure	Vadadustat 150 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=12 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=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	3 Participants	1 Participants	2 Participants	0 Participants	0 Participants	1 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	5 Participants	7 Participants	1 Participants	3 Participants	1 Participants	1 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	3 Participants	4 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	1 Participants	0 Participants	7 Participants	1 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline to Week 6

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

Iron sufficiency was defined as ferritin ≥50 ng/mL and TSAT ≥20%.

Outcome measures

Measure	Vadadustat 150 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=12 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=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 Maintained Iron Sufficiency From Baseline to Week 6 Iron sufficiency maintained	7 Participants	4 Participants	4 Participants	9 Participants	—	—
Number of Participants Who Maintained Iron Sufficiency From Baseline to Week 6 Iron sufficiency not maintained	5 Participants	8 Participants	9 Participants	5 Participants	—	—

SECONDARY outcome

Timeframe: Baseline to Week 16

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

Iron sufficiency was defined as ferritin ≥50 ng/mL and TSAT ≥20%.

Outcome measures

Measure	Vadadustat 150 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=12 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=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 Maintained Iron Sufficiency From Baseline to Week 16 Iron sufficiency maintained	6 Participants	2 Participants	4 Participants	1 Participants	1 Participants	0 Participants
Number of Participants Who Maintained Iron Sufficiency From Baseline to Week 16 Iron sufficiency not maintained	6 Participants	10 Participants	9 Participants	4 Participants	3 Participants	5 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 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=12 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	5530.9 micrograms per milliliter (µg/mL) Standard Deviation 4168.86	12955.8 micrograms per milliliter (µg/mL) Standard Deviation 9771.65	19291.5 micrograms per milliliter (µg/mL) Standard Deviation 9325.30	—	—	—
Plasma Concentration Profile of Vadadustat and Its Metabolites Using a Pre-dose Sample From Week 4 O-glucuronide	3914.7 micrograms per milliliter (µg/mL) Standard Deviation 5772.39	12358.6 micrograms per milliliter (µg/mL) Standard Deviation 7586.73	16586.2 micrograms per milliliter (µg/mL) Standard Deviation 12363.44	—	—	—
Plasma Concentration Profile of Vadadustat and Its Metabolites Using a Pre-dose Sample From Week 4 Acyl-glucuronide	0.00 micrograms per milliliter (µg/mL) Standard Deviation 0.000	1.95 micrograms per milliliter (µg/mL) Standard Deviation 6.755	8.99 micrograms per milliliter (µg/mL) Standard Deviation 16.430	—	—	—

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 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=12 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=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 With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs) in the Primary Efficacy Period TEAEs	4 Participants	7 Participants	7 Participants	5 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	0 Participants	0 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 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=12 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=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 With TEAEs and Treatment-emergent SAEs in the Dose Adjustment and Maintenance Period TEAEs	9 Participants	10 Participants	6 Participants	3 Participants	3 Participants	3 Participants
Number of Participants With TEAEs and Treatment-emergent SAEs in the Dose Adjustment and Maintenance Period Treatment-emergent SAEs	0 Participants	5 Participants	2 Participants	1 Participants	1 Participants	2 Participants

Adverse Events

Primary Efficacy Period: 150 mg Vadadustat

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Primary Efficacy Period: 300 mg Vadadustat

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Primary Efficacy Period: 600 mg Vadadustat

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Primary Efficacy Period: Placebo Matched to 150 mg Vadadustat

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Primary Efficacy Period: Placebo Matched to 300 mg Vadadustat

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Primary Efficacy Period: Placebo Matched to 600 mg Vadadustat

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Dose Adjustment and Maintenance: 150 mg Vadadustat

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Dose Adjustment and Maintenance: 300 mg Vadadustat

Serious events: 5 serious events

Other events: 10 other events

Deaths: 0 deaths

Dose Adjustment and Maintenance: 600 mg Vadadustat

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Dose Adjustment and Maintenance: Placebo to 150 mg Vadadustat

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Dose Adjustment and Maintenance: Placebo to 300 mg Vadadustat

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Dose Adjustment and Maintenance: Placebo to 600 mg Vadadustat

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Primary Efficacy Period: 150 mg Vadadustat n=12 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=12 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=13 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=4 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=12 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 per deciliter (g/dL) based on dose adjustment guidelines.	Dose Adjustment and Maintenance: 300 mg Vadadustat n=12 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=13 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.	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=4 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.
Gastrointestinal disorders Duodenal ulcer hemorrhage	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	20.0% 1/5 • up to Week 18
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Infections and infestations Influenza	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	25.0% 1/4 • up to Week 18	0.00% 0/5 • up to Week 18
Infections and infestations Lung infection	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	7.7% 1/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	20.0% 1/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Renal and urinary disorders Acute kidney injury	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	7.7% 1/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Renal and urinary disorders End-stage renal disease	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Renal and urinary disorders Renal impairment	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	20.0% 1/5 • up to Week 18
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	20.0% 1/5 • up to Week 18
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	7.7% 1/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Surgical and medical procedures Arteriovenous shunt procedure	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	25.0% 3/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18

Other adverse events

Measure	Primary Efficacy Period: 150 mg Vadadustat n=12 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=12 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=13 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=4 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=12 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 per deciliter (g/dL) based on dose adjustment guidelines.	Dose Adjustment and Maintenance: 300 mg Vadadustat n=12 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=13 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.	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=4 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.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	25.0% 1/4 • up to Week 18	0.00% 0/5 • up to Week 18	8.3% 1/12 • up to Week 18	8.3% 1/12 • up to Week 18	7.7% 1/13 • up to Week 18	20.0% 1/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Vascular disorders Hypertension	0.00% 0/12 • up to Week 18	25.0% 3/12 • up to Week 18	15.4% 2/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Gastrointestinal disorders Constipation	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	16.7% 2/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	20.0% 1/5 • up to Week 18
Gastrointestinal disorders Diarrhoea	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	7.7% 1/13 • up to Week 18	20.0% 1/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Gastrointestinal disorders Nausea	0.00% 0/12 • up to Week 18	16.7% 2/12 • up to Week 18	7.7% 1/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
General disorders Oedema due to renal disease	8.3% 1/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	20.0% 1/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	20.0% 1/5 • up to Week 18
Infections and infestations Influenza	8.3% 1/12 • up to Week 18	0.00% 0/12 • up to Week 18	7.7% 1/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Injury, poisoning and procedural complications Contusion	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	20.0% 1/5 • up to Week 18	16.7% 2/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	7.7% 1/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	7.7% 1/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	8.3% 1/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Gastrointestinal disorders Abdominal distension	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	8.3% 1/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Gastrointestinal disorders Dental caries	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	20.0% 1/5 • up to Week 18
Injury, poisoning and procedural complications Fall	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	20.0% 1/5 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Metabolism and nutrition disorders Dehydration	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	20.0% 1/5 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Psychiatric disorders Delirium	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/12 • up to Week 18	7.7% 1/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Gastrointestinal disorders Stomatitis	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	25.0% 1/4 • up to Week 18	0.00% 0/5 • up to Week 18
Infections and infestations Cystitis	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	25.0% 1/4 • up to Week 18	0.00% 0/5 • up to Week 18
Infections and infestations Herpes simplex	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	20.0% 1/5 • up to Week 18
Nervous system disorders Dizziness	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	25.0% 1/4 • up to Week 18	0.00% 0/5 • up to Week 18
Nervous system disorders Loss of consciousness	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	25.0% 1/4 • up to Week 18	0.00% 0/5 • up to Week 18
Reproductive system and breast disorders Uterine prolapse	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	25.0% 1/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Eye disorders Conjunctival haemorrhage	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	7.7% 1/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Gastrointestinal disorders Periodontal disease	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Gastrointestinal disorders Vomiting	8.3% 1/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
General disorders Oedema peripheral	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Infections and infestations Angular cheilitis	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Infections and infestations Urinary tract infection	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	7.7% 1/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Investigations Aspartate aminotransferase increased	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	7.7% 1/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Renal and urinary disorders Renal impairment	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Vascular disorders Orthostatic hypotension	8.3% 1/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Endocrine disorders Hypothyroidism	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Endocrine disorders Parathyroid gland enlargement	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Gastrointestinal disorders Enterocolitis	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Gastrointestinal disorders Tooth loss	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Gastrointestinal disorders Abdominal pain	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Infections and infestations Herpes zoster	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Infections and infestations Otitis externa	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Infections and infestations Paronychia	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Infections and infestations Upper respiratory tract infection bacterial	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Injury, poisoning and procedural complications Face injury	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Injury, poisoning and procedural complications Injury	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Injury, poisoning and procedural complications Laceration	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	7.7% 1/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Injury, poisoning and procedural complications Wound	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	7.7% 1/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Nervous system disorders Headache	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Renal and urinary disorders Chronic kidney disease	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Renal and urinary disorders Diabetic nephropathy	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Renal and urinary disorders Hypertensive nephropathy	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Renal and urinary disorders Pollakiuria	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	7.7% 1/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Respiratory, thoracic and mediastinal disorders Reflux laryngitis	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Skin and subcutaneous tissue disorders Eczema	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Skin and subcutaneous tissue disorders Eczema asteatotic	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	8.3% 1/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18
Infections and infestations Upper respiratory tract infection	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/12 • up to Week 18	0.00% 0/12 • up to Week 18	7.7% 1/13 • up to Week 18	0.00% 0/5 • up to Week 18	0.00% 0/4 • 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