Trial Outcomes & Findings for Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of GSK1278863 in Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease Who Are Switched From a Stable Dose of an Erythropoiesis-stimulating Agent (NCT NCT02689206)

Results Overview

Blood samples were collected from participants for measurement of Hgb values. Baseline is the average of Hgb measured at Week -2 and Day 1 visits. Change from Baseline at Day 29 was defined as post dose value at Day 29 minus Baseline value. The analysis was performed on intent-to-treat (ITT) Population which comprised of all randomized participants who received at least one dose of study treatment, had a Baseline and at least one corresponding on treatment assessment, including Hgb.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

103 participants

Primary outcome timeframe

Baseline and Day 29

Results posted on

2020-02-25

Participant Flow

Participants on Hemodialysis (HD) with anemia associated with chronic kidney disease (CKD) switching from Erythropoiesis-Stimulating Agent (ESA) treatment were recruited in this randomized, dose-ranging study. Participants with hemoglobin (Hgb) values between 9.0- 11.5 grams per deciliter (g/dL) were considered as eligible for recruitment.

A total of 211 participants were screened; of which 108 were screen failures and 103 were randomized to receive at least one dose of either placebo or 10, 15, 25 or 30 milligrams (mg) of daprodustat (dapro). One participant who was randomized to the placebo group, erroneously received 25 mg dapro treatment throughout the 29-day treatment period

Participant milestones

Participant milestones
Measure	Placebo Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Overall Study STARTED	20	20	20	21	22
Overall Study COMPLETED	17	19	16	17	14
Overall Study NOT COMPLETED	3	1	4	4	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Overall Study Adverse Event	0	0	1	0	2
Overall Study Protocol Violation	1	0	0	1	2
Overall Study Other: Reached stopping criteria	0	1	2	3	4
Overall Study Physician Decision	1	0	0	0	0
Overall Study Withdrawal by Subject	1	0	1	0	0

Baseline Characteristics

Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of GSK1278863 in Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease Who Are Switched From a Stable Dose of an Erythropoiesis-stimulating Agent

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=20 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=21 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days	Total n=103 Participants Total of all reporting groups
Age, Continuous	61.0 Years STANDARD_DEVIATION 13.06 • n=5 Participants	63.6 Years STANDARD_DEVIATION 16.98 • n=7 Participants	59.5 Years STANDARD_DEVIATION 12.26 • n=5 Participants	67.2 Years STANDARD_DEVIATION 15.22 • n=4 Participants	65.4 Years STANDARD_DEVIATION 13.97 • n=21 Participants	63.4 Years STANDARD_DEVIATION 14.39 • n=8 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	9 Participants n=4 Participants	8 Participants n=21 Participants	42 Participants n=8 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	12 Participants n=7 Participants	14 Participants n=5 Participants	12 Participants n=4 Participants	14 Participants n=21 Participants	61 Participants n=8 Participants
Race/Ethnicity, Customized Race customized · African American/African Heritage	6 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	5 Participants n=4 Participants	6 Participants n=21 Participants	30 Participants n=8 Participants
Race/Ethnicity, Customized Race customized · American Indian Or Alaskan Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants
Race/Ethnicity, Customized Race customized · Asian - Central/South Asian Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants
Race/Ethnicity, Customized Race customized · Native Hawaiian Or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Race customized · White- Arabic/North African Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Race customized · White-White/Caucasian/European Heritage	14 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	14 Participants n=4 Participants	15 Participants n=21 Participants	67 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline and Day 29

Population: ITT Population

Blood samples were collected from participants for measurement of Hgb values. Baseline is the average of Hgb measured at Week -2 and Day 1 visits. Change from Baseline at Day 29 was defined as post dose value at Day 29 minus Baseline value. The analysis was performed on intent-to-treat (ITT) Population which comprised of all randomized participants who received at least one dose of study treatment, had a Baseline and at least one corresponding on treatment assessment, including Hgb.

Outcome measures

Outcome measures
Measure	Placebo n=17 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=19 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=16 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=17 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=15 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Change From Baseline in Hgb Levels at Day 29	-0.61 g/dL Standard Deviation 0.646	-0.19 g/dL Standard Deviation 1.750	-0.13 g/dL Standard Deviation 1.088	0.64 g/dL Standard Deviation 1.453	0.55 g/dL Standard Deviation 1.167

SECONDARY outcome

Timeframe: Baseline and up to Day 29

Population: ITT Population

Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect of dapro three times weekly dose regimens on EPO. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. The change from Baseline at each given post-Baseline time point was calculated and the maximum change from Baseline was determined.

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=18 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=21 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=20 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Maximum Observed Change From Baseline in Plasma Erythropoietin (EPO)	53.761 International unit per liter (IU/L) Standard Deviation 132.6875	2.255 International unit per liter (IU/L) Standard Deviation 84.8921	73.369 International unit per liter (IU/L) Standard Deviation 95.9772	302.529 International unit per liter (IU/L) Standard Deviation 469.8312	477.644 International unit per liter (IU/L) Standard Deviation 388.9757

SECONDARY outcome

Timeframe: Baseline and up to Day 29

Population: ITT Population

Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect of dapro three times weekly dose regimens on VEGF. Day 1 values were considered as Baseline values. The percent change from Baseline at each given post-Baseline time point was calculated (expressed as geometric mean) and the maximum percent change from Baseline was determined.

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=18 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=21 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=20 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)	20.35 Nanograms per liter (ng/L) Interval -0.48 to 45.55	43.75 Nanograms per liter (ng/L) Interval 16.44 to 77.45	32.16 Nanograms per liter (ng/L) Interval -4.77 to 83.41	53.34 Nanograms per liter (ng/L) Interval 17.17 to 100.68	76.09 Nanograms per liter (ng/L) Interval 34.89 to 129.88

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: ITT Population

Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect of dapro three times weekly dose regimens on hepcidin. Day 1 values were considered as Baseline values. The Percent change from Baseline at Day 29 post-Baseline time point was calculated and expressed as geometric mean and the maximum change from Baseline was determined.

Outcome measures

Outcome measures
Measure	Placebo n=17 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=19 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=15 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=17 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=15 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Percent Change From Baseline in Hepcidin at Day 29	27.81 Micrograms per liter (µg/L) Interval -12.68 to 87.08	35.37 Micrograms per liter (µg/L) Interval -1.13 to 85.34	3.83 Micrograms per liter (µg/L) Interval -17.85 to 31.24	-36.74 Micrograms per liter (µg/L) Interval -49.91 to -20.12	-36.09 Micrograms per liter (µg/L) Interval -57.24 to -4.48

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: ITT Population

Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect Dapro three times weekly dose regimens on hematocrit. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-dose visit values minus Baseline value. The change from Baseline at Day 29 post-Baseline time point was calculated.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=19 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=14 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=16 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=15 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Change From Baseline in Hematocrit Levels	-0.0218 Proportion of red blood cells in blood Standard Deviation 0.02469	-0.0127 Proportion of red blood cells in blood Standard Deviation 0.05396	-0.0149 Proportion of red blood cells in blood Standard Deviation 0.05379	0.0150 Proportion of red blood cells in blood Standard Deviation 0.04511	0.0215 Proportion of red blood cells in blood Standard Deviation 0.03852

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: ITT Population

Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect Dapro three times weekly dose regimens on RBC count. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-dose visit values minus Baseline value. The change from Baseline at Day 29 post-Baseline time point was calculated.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=19 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=14 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=16 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=15 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Change From Baseline in Red Blood Cell (RBC) Count	-0.19 10^12 cells/L Standard Deviation 0.263	-0.12 10^12 cells/L Standard Deviation 0.494	-0.13 10^12 cells/L Standard Deviation 0.500	0.12 10^12 cells/L Standard Deviation 0.420	0.15 10^12 cells/L Standard Deviation 0.342

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: ITT Population

Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect Dapro three times weekly dose regimens on reticulocyte count. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. The change from Baseline at Day 29 post-Baseline time point was calculated.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=18 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=14 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=16 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=15 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Change From Baseline in Reticulocyte Count	-0.08 Percentage of reticulocyte Standard Deviation 0.848	-0.11 Percentage of reticulocyte Standard Deviation 0.803	-0.04 Percentage of reticulocyte Standard Deviation 0.581	0.43 Percentage of reticulocyte Standard Deviation 0.547	0.09 Percentage of reticulocyte Standard Deviation 0.695

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: ITT Population

Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect Dapro three times weekly dose regimens on CHr. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. The change from Baseline at Day 29 post-Baseline time point was calculated.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=19 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=14 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=16 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=15 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Change From Baseline in Reticulocyte Hemoglobin (CHr)	-0.15 Picograms (pg) Standard Deviation 1.375	0.23 Picograms (pg) Standard Deviation 1.335	0.26 Picograms (pg) Standard Deviation 1.103	0.23 Picograms (pg) Standard Deviation 1.040	0.59 Picograms (pg) Standard Deviation 1.436

SECONDARY outcome

Timeframe: Pre-dose on Day 1; 6-10 hours, 7-11 hours, 8-12 hours, 9-13 hours post dose on Day 15; pre-dose and 1, 2, 3 hours post-dose on Day 29

Population: PK Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of dapro. The data from each PK sampling day was combined to generate a single profile, and normalized to a 24-hour period to create a "Day 1" profile for non-compartmental analysis (NCA). Metabolite plasma concentrations were analyzed but PK parameters could not be calculated as the metabolites were partially eliminated through dialysis and the dialysis start and end times were not consistent on both PK days. Therefore, a representative metabolite PK profile could not be generated. The analysis was performed on PK Population, which comprised of all participants from whom a PK sample has been obtained and analyzed. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=22 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Area Under the Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) and AUC From Time Zero to Infinity (AUC[0-inf]) of Dapro AUC (0-t); n= 19, 15, 16, 14	311.7 hour into nanograms/milliliter (h*ng/mL) Geometric Coefficient of Variation 91.4	416.7 hour into nanograms/milliliter (h*ng/mL) Geometric Coefficient of Variation 168.6	513.9 hour into nanograms/milliliter (h*ng/mL) Geometric Coefficient of Variation 396.1	1010 hour into nanograms/milliliter (h*ng/mL) Geometric Coefficient of Variation 92.3	—
Area Under the Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) and AUC From Time Zero to Infinity (AUC[0-inf]) of Dapro AUC (0-inf); n= 12, 9, 8, 11	348.2 hour into nanograms/milliliter (h*ng/mL) Geometric Coefficient of Variation 78.2	383.5 hour into nanograms/milliliter (h*ng/mL) Geometric Coefficient of Variation 142.7	1214 hour into nanograms/milliliter (h*ng/mL) Geometric Coefficient of Variation 41.6	1369 hour into nanograms/milliliter (h*ng/mL) Geometric Coefficient of Variation 59.3	—

SECONDARY outcome

Timeframe: Pre-dose on Day 1; 6-10 hours, 7-11 hours, 8-12 hours, 9-13 hours post dose on Day 15; pre-dose and 1, 2, 3 hours post-dose on Day 29

Population: PK Population

Blood samples were collected at indicated time points for PK analysis of dapro. The data from each PK sampling day was combined to generate a single profile, and normalized to a 24-hour period to create a "Day 1" profile for NCA. Metabolite plasma concentrations were analyzed but PK parameters could not be calculated as the metabolites were partially eliminated through dialysis and the dialysis start and end times were not consistent on both PK days. Therefore, a representative metabolite PK profile could not be generated.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=15 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=16 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=14 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Maximum Observed Concentration of Dapro in Plasma (Cmax)	140.0 ng/mL Geometric Coefficient of Variation 104.0	141.4 ng/mL Geometric Coefficient of Variation 248.8	246.9 ng/mL Geometric Coefficient of Variation 311.5	387.3 ng/mL Geometric Coefficient of Variation 99.4	—

SECONDARY outcome

Timeframe: Pre-dose on Day 1; 6-10 hours, 7-11 hours, 8-12 hours, 9-13 hours post dose on Day 15; pre-dose and 1, 2, 3 hours post-dose on Day 29

Population: PK Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Blood samples were collected at indicated time points for PK analysis of dapro. The data from each PK sampling day was combined to generate a single profile, and normalized to a 24-hour period to create a "Day 1" profile for NCA. Metabolite plasma concentrations were analyzed but PK parameters could not be calculated as the metabolites were partially eliminated through dialysis and the dialysis start and end times were not consistent on both PK days. Therefore, a representative metabolite PK profile could not be generated. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=22 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Time to Reach Cmax (Tmax) and Apparent Terminal Half-life (t1/2) of Dapro Tmax; n= 19, 15, 16, 14	2.456 Hour Geometric Coefficient of Variation 78.9	2.106 Hour Geometric Coefficient of Variation 82.1	2.297 Hour Geometric Coefficient of Variation 96.5	1.718 Hour Geometric Coefficient of Variation 58.0	—
Time to Reach Cmax (Tmax) and Apparent Terminal Half-life (t1/2) of Dapro T1/2; n= 12, 9, 8, 11	2.086 Hour Geometric Coefficient of Variation 50.0	1.886 Hour Geometric Coefficient of Variation 62.3	1.418 Hour Geometric Coefficient of Variation 58.4	2.897 Hour Geometric Coefficient of Variation 38.7	—

SECONDARY outcome

Timeframe: Up to Day 43

Population: Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Reasons of study treatment discontinuation included adverse events (AEs), protocol deviation, participants reached protocol defined stopping criteria, physician decision and withdrawal by participants. Number of participants who discontinued study treatment are presented. Analysis was performed on Safety Population which comprised of all participants who received at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Number of Participants Who Discontinued Study Treatment AEs	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants Who Discontinued Study Treatment Protocol deviation	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Number of Participants Who Discontinued Study Treatment Participant reached stopping criteria	0 Participants	1 Participants	2 Participants	3 Participants	4 Participants
Number of Participants Who Discontinued Study Treatment Physician decision	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Who Discontinued Study Treatment Withdrawal by subject	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 43

Population: Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Number of Participants With AEs and Serious Adverse Events (SAEs) Any AE	10 Participants	10 Participants	6 Participants	7 Participants	7 Participants
Number of Participants With AEs and Serious Adverse Events (SAEs) Any SAE	4 Participants	3 Participants	2 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to Day 43

Population: Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Serum sodium, potassium, glucose, corrected calcium and phosphate levels were assessed as a clinical chemistry laboratory parameter from Baseline up to follow up visit at Day 43. Day 1 values were considered as Baseline values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Sodium, Potassium, Glucose, Calcium, Phosphate Levels in Blood at Indicated Time Points Calcium corrected; Day 15; n= 17, 20, 18, 22, 20	2.261 Millimoles per liter (mmol/L) Standard Deviation 0.1698	2.219 Millimoles per liter (mmol/L) Standard Deviation 0.1252	2.213 Millimoles per liter (mmol/L) Standard Deviation 0.1723	2.188 Millimoles per liter (mmol/L) Standard Deviation 0.1360	2.203 Millimoles per liter (mmol/L) Standard Deviation 0.1111
Sodium, Potassium, Glucose, Calcium, Phosphate Levels in Blood at Indicated Time Points Calcium corrected; Day 29; n= 17, 19, 18, 19, 17	2.205 Millimoles per liter (mmol/L) Standard Deviation 0.1431	2.248 Millimoles per liter (mmol/L) Standard Deviation 0.1352	2.244 Millimoles per liter (mmol/L) Standard Deviation 0.1577	2.198 Millimoles per liter (mmol/L) Standard Deviation 0.1343	2.225 Millimoles per liter (mmol/L) Standard Deviation 0.1810
Sodium, Potassium, Glucose, Calcium, Phosphate Levels in Blood at Indicated Time Points Sodium; Day 1; n= 18, 20, 20, 22, 22	138.8 Millimoles per liter (mmol/L) Standard Deviation 2.85	138.1 Millimoles per liter (mmol/L) Standard Deviation 2.31	138.7 Millimoles per liter (mmol/L) Standard Deviation 2.83	139.4 Millimoles per liter (mmol/L) Standard Deviation 2.38	138.4 Millimoles per liter (mmol/L) Standard Deviation 1.76
Sodium, Potassium, Glucose, Calcium, Phosphate Levels in Blood at Indicated Time Points Sodium; Day 15; n= 17, 20, 18, 22, 20	137.7 Millimoles per liter (mmol/L) Standard Deviation 3.16	137.5 Millimoles per liter (mmol/L) Standard Deviation 2.72	138.1 Millimoles per liter (mmol/L) Standard Deviation 1.60	138.0 Millimoles per liter (mmol/L) Standard Deviation 2.36	137.2 Millimoles per liter (mmol/L) Standard Deviation 1.74
Sodium, Potassium, Glucose, Calcium, Phosphate Levels in Blood at Indicated Time Points Sodium; Day 29; n= 17, 19, 18, 19, 17	137.8 Millimoles per liter (mmol/L) Standard Deviation 3.96	136.8 Millimoles per liter (mmol/L) Standard Deviation 2.70	137.9 Millimoles per liter (mmol/L) Standard Deviation 2.85	138.8 Millimoles per liter (mmol/L) Standard Deviation 2.74	137.1 Millimoles per liter (mmol/L) Standard Deviation 2.46
Sodium, Potassium, Glucose, Calcium, Phosphate Levels in Blood at Indicated Time Points Sodium; Day 43; n= 15, 20, 18, 21, 21	139.2 Millimoles per liter (mmol/L) Standard Deviation 2.88	138.1 Millimoles per liter (mmol/L) Standard Deviation 1.77	137.9 Millimoles per liter (mmol/L) Standard Deviation 2.37	138.8 Millimoles per liter (mmol/L) Standard Deviation 2.02	137.6 Millimoles per liter (mmol/L) Standard Deviation 1.88
Sodium, Potassium, Glucose, Calcium, Phosphate Levels in Blood at Indicated Time Points Potassium; Day 1; n= 18, 20, 20, 22, 22	4.68 Millimoles per liter (mmol/L) Standard Deviation 0.840	4.73 Millimoles per liter (mmol/L) Standard Deviation 0.768	4.64 Millimoles per liter (mmol/L) Standard Deviation 0.826	4.79 Millimoles per liter (mmol/L) Standard Deviation 0.514	4.83 Millimoles per liter (mmol/L) Standard Deviation 0.685
Sodium, Potassium, Glucose, Calcium, Phosphate Levels in Blood at Indicated Time Points Potassium; Day 15; n= 17, 20, 18, 22, 20	4.72 Millimoles per liter (mmol/L) Standard Deviation 0.763	4.77 Millimoles per liter (mmol/L) Standard Deviation 0.542	4.57 Millimoles per liter (mmol/L) Standard Deviation 0.635	4.82 Millimoles per liter (mmol/L) Standard Deviation 0.765	4.80 Millimoles per liter (mmol/L) Standard Deviation 0.791
Sodium, Potassium, Glucose, Calcium, Phosphate Levels in Blood at Indicated Time Points Potassium; Day 29; n= 17, 19, 18, 19, 17	4.78 Millimoles per liter (mmol/L) Standard Deviation 0.919	4.87 Millimoles per liter (mmol/L) Standard Deviation 0.751	4.57 Millimoles per liter (mmol/L) Standard Deviation 0.472	4.86 Millimoles per liter (mmol/L) Standard Deviation 0.619	4.96 Millimoles per liter (mmol/L) Standard Deviation 0.941
Sodium, Potassium, Glucose, Calcium, Phosphate Levels in Blood at Indicated Time Points Potassium; Day 43; n= 15, 20, 18, 21, 21	4.69 Millimoles per liter (mmol/L) Standard Deviation 0.951	4.68 Millimoles per liter (mmol/L) Standard Deviation 0.562	4.59 Millimoles per liter (mmol/L) Standard Deviation 0.657	4.76 Millimoles per liter (mmol/L) Standard Deviation 0.752	4.80 Millimoles per liter (mmol/L) Standard Deviation 0.946
Sodium, Potassium, Glucose, Calcium, Phosphate Levels in Blood at Indicated Time Points Glucose; Day 1; n= 18, 20, 20, 22, 22	6.66 Millimoles per liter (mmol/L) Standard Deviation 3.088	6.66 Millimoles per liter (mmol/L) Standard Deviation 2.716	6.41 Millimoles per liter (mmol/L) Standard Deviation 3.507	7.05 Millimoles per liter (mmol/L) Standard Deviation 2.491	8.95 Millimoles per liter (mmol/L) Standard Deviation 5.012
Sodium, Potassium, Glucose, Calcium, Phosphate Levels in Blood at Indicated Time Points Glucose; Day 15; n= 17, 20, 18, 22, 20	7.89 Millimoles per liter (mmol/L) Standard Deviation 3.425	7.16 Millimoles per liter (mmol/L) Standard Deviation 2.844	7.03 Millimoles per liter (mmol/L) Standard Deviation 3.236	7.26 Millimoles per liter (mmol/L) Standard Deviation 2.852	8.67 Millimoles per liter (mmol/L) Standard Deviation 4.198
Sodium, Potassium, Glucose, Calcium, Phosphate Levels in Blood at Indicated Time Points Glucose; Day 29; n= 17, 19, 18, 19, 17	8.21 Millimoles per liter (mmol/L) Standard Deviation 4.951	7.49 Millimoles per liter (mmol/L) Standard Deviation 3.949	7.21 Millimoles per liter (mmol/L) Standard Deviation 3.953	7.77 Millimoles per liter (mmol/L) Standard Deviation 4.621	8.75 Millimoles per liter (mmol/L) Standard Deviation 5.708
Sodium, Potassium, Glucose, Calcium, Phosphate Levels in Blood at Indicated Time Points Glucose; Day 43; n= 15, 20, 18, 21, 21	6.93 Millimoles per liter (mmol/L) Standard Deviation 3.126	6.72 Millimoles per liter (mmol/L) Standard Deviation 2.965	7.09 Millimoles per liter (mmol/L) Standard Deviation 3.533	6.27 Millimoles per liter (mmol/L) Standard Deviation 1.958	8.93 Millimoles per liter (mmol/L) Standard Deviation 4.280
Sodium, Potassium, Glucose, Calcium, Phosphate Levels in Blood at Indicated Time Points Calcium corrected; Day 1; n= 18, 20, 20, 22, 22	2.286 Millimoles per liter (mmol/L) Standard Deviation 0.2116	2.270 Millimoles per liter (mmol/L) Standard Deviation 0.1244	2.241 Millimoles per liter (mmol/L) Standard Deviation 0.1675	2.219 Millimoles per liter (mmol/L) Standard Deviation 0.1589	2.215 Millimoles per liter (mmol/L) Standard Deviation 0.1163
Sodium, Potassium, Glucose, Calcium, Phosphate Levels in Blood at Indicated Time Points Calcium corrected; Day 43; n= 15, 20, 18, 21, 21	2.251 Millimoles per liter (mmol/L) Standard Deviation 0.1582	2.235 Millimoles per liter (mmol/L) Standard Deviation 0.1593	2.271 Millimoles per liter (mmol/L) Standard Deviation 0.1823	2.201 Millimoles per liter (mmol/L) Standard Deviation 0.1206	2.256 Millimoles per liter (mmol/L) Standard Deviation 0.1473
Sodium, Potassium, Glucose, Calcium, Phosphate Levels in Blood at Indicated Time Points Phosphate; Day 1; n= 18, 20, 20, 22, 22	1.608 Millimoles per liter (mmol/L) Standard Deviation 0.5143	1.528 Millimoles per liter (mmol/L) Standard Deviation 0.5557	1.498 Millimoles per liter (mmol/L) Standard Deviation 0.5265	1.318 Millimoles per liter (mmol/L) Standard Deviation 0.3647	1.566 Millimoles per liter (mmol/L) Standard Deviation 0.4269
Sodium, Potassium, Glucose, Calcium, Phosphate Levels in Blood at Indicated Time Points Phosphate; Day 15; n= 17, 20, 18, 22, 20	1.621 Millimoles per liter (mmol/L) Standard Deviation 0.4221	1.710 Millimoles per liter (mmol/L) Standard Deviation 0.3912	1.642 Millimoles per liter (mmol/L) Standard Deviation 0.5021	1.348 Millimoles per liter (mmol/L) Standard Deviation 0.3138	1.645 Millimoles per liter (mmol/L) Standard Deviation 0.4785
Sodium, Potassium, Glucose, Calcium, Phosphate Levels in Blood at Indicated Time Points Phosphate; Day 29; n= 17, 19, 18, 19, 17	1.709 Millimoles per liter (mmol/L) Standard Deviation 0.5872	1.592 Millimoles per liter (mmol/L) Standard Deviation 0.4121	1.644 Millimoles per liter (mmol/L) Standard Deviation 0.5322	1.453 Millimoles per liter (mmol/L) Standard Deviation 0.4489	1.550 Millimoles per liter (mmol/L) Standard Deviation 0.3575
Sodium, Potassium, Glucose, Calcium, Phosphate Levels in Blood at Indicated Time Points Phosphate; Day 43; n= 15, 20, 18, 21, 21	1.550 Millimoles per liter (mmol/L) Standard Deviation 0.5828	1.460 Millimoles per liter (mmol/L) Standard Deviation 0.4550	1.472 Millimoles per liter (mmol/L) Standard Deviation 0.4240	1.412 Millimoles per liter (mmol/L) Standard Deviation 0.4441	1.398 Millimoles per liter (mmol/L) Standard Deviation 0.4718

SECONDARY outcome

Timeframe: Up to Day 43

Population: Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Serum albumin and protein levels were assessed as a clinical chemistry laboratory parameter from Baseline up to follow up visit at Day 43. Day 1 values were considered as Baseline values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Albumin and Protein Levels in Blood at Indicated Tme Points Albumin; Day 1; n= 18, 20, 20, 22, 22	37.6 grams per liter (g/L) Standard Deviation 2.89	38.6 grams per liter (g/L) Standard Deviation 2.46	38.7 grams per liter (g/L) Standard Deviation 3.84	38.8 grams per liter (g/L) Standard Deviation 2.22	38.1 grams per liter (g/L) Standard Deviation 3.52
Albumin and Protein Levels in Blood at Indicated Tme Points Albumin; Day 15; n= 17, 20, 18, 22, 20	38.1 grams per liter (g/L) Standard Deviation 2.68	38.1 grams per liter (g/L) Standard Deviation 2.65	38.4 grams per liter (g/L) Standard Deviation 3.42	38.4 grams per liter (g/L) Standard Deviation 2.52	37.2 grams per liter (g/L) Standard Deviation 3.01
Albumin and Protein Levels in Blood at Indicated Tme Points Albumin; Day 29; n= 17, 19, 18, 19, 17	36.5 grams per liter (g/L) Standard Deviation 3.22	37.2 grams per liter (g/L) Standard Deviation 3.26	37.6 grams per liter (g/L) Standard Deviation 3.62	37.4 grams per liter (g/L) Standard Deviation 2.17	36.9 grams per liter (g/L) Standard Deviation 4.15
Albumin and Protein Levels in Blood at Indicated Tme Points Albumin; Day 43; n= 15, 20, 18, 21, 21	37.1 grams per liter (g/L) Standard Deviation 2.85	38.1 grams per liter (g/L) Standard Deviation 3.02	37.9 grams per liter (g/L) Standard Deviation 3.95	39.0 grams per liter (g/L) Standard Deviation 3.11	37.5 grams per liter (g/L) Standard Deviation 2.86
Albumin and Protein Levels in Blood at Indicated Tme Points Protein; Day 1; n= 18, 20 ,20, 22, 22	67.3 grams per liter (g/L) Standard Deviation 4.90	66.9 grams per liter (g/L) Standard Deviation 5.42	67.4 grams per liter (g/L) Standard Deviation 4.89	66.4 grams per liter (g/L) Standard Deviation 5.16	65.7 grams per liter (g/L) Standard Deviation 4.65
Albumin and Protein Levels in Blood at Indicated Tme Points Protein; Day 15; n= 17, 20, 18, 22, 20	68.1 grams per liter (g/L) Standard Deviation 4.87	66.5 grams per liter (g/L) Standard Deviation 4.88	67.3 grams per liter (g/L) Standard Deviation 4.28	65.6 grams per liter (g/L) Standard Deviation 5.13	64.3 grams per liter (g/L) Standard Deviation 4.70
Albumin and Protein Levels in Blood at Indicated Tme Points Protein; Day 29; n= 17, 19, 18, 19, 17	66.1 grams per liter (g/L) Standard Deviation 4.52	65.7 grams per liter (g/L) Standard Deviation 4.75	66.0 grams per liter (g/L) Standard Deviation 4.51	65.5 grams per liter (g/L) Standard Deviation 6.50	65.3 grams per liter (g/L) Standard Deviation 5.30
Albumin and Protein Levels in Blood at Indicated Tme Points Protein; Day 43; n= 15, 20, 18, 21, 21	67.2 grams per liter (g/L) Standard Deviation 4.25	67.4 grams per liter (g/L) Standard Deviation 5.14	66.8 grams per liter (g/L) Standard Deviation 4.02	66.7 grams per liter (g/L) Standard Deviation 7.70	66.6 grams per liter (g/L) Standard Deviation 6.34

SECONDARY outcome

Timeframe: Up to Day 43

Population: Safety Population One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Serum ALT, AST and alk. phosph. levels were assessed as a clinical chemistry laboratory parameter from Baseline up to follow up visit at Day 43. Day 1 values were considered as Baseline values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (Alk. Phosph) Levels in Blood at Indicated Time Points ALT; Day 1; n= 18, 20, 20, 22, 22	12.6 IU/L Standard Deviation 9.36	13.4 IU/L Standard Deviation 7.51	14.6 IU/L Standard Deviation 11.39	10.7 IU/L Standard Deviation 5.75	11.5 IU/L Standard Deviation 5.94
Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (Alk. Phosph) Levels in Blood at Indicated Time Points ALT; Day 15; n= 17, 20, 18, 22, 20	16.5 IU/L Standard Deviation 13.80	13.9 IU/L Standard Deviation 10.58	12.4 IU/L Standard Deviation 7.87	11.9 IU/L Standard Deviation 6.58	8.4 IU/L Standard Deviation 2.11
Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (Alk. Phosph) Levels in Blood at Indicated Time Points ALT; Day 29; n= 17, 19, 18, 19, 17	24.4 IU/L Standard Deviation 32.34	12.8 IU/L Standard Deviation 6.43	12.2 IU/L Standard Deviation 6.40	10.9 IU/L Standard Deviation 5.67	8.6 IU/L Standard Deviation 3.12
Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (Alk. Phosph) Levels in Blood at Indicated Time Points ALT; Day 43; n= 15, 20, 18, 21, 21	14.3 IU/L Standard Deviation 8.55	13.8 IU/L Standard Deviation 8.03	12.8 IU/L Standard Deviation 6.89	13.1 IU/L Standard Deviation 5.19	11.2 IU/L Standard Deviation 5.57
Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (Alk. Phosph) Levels in Blood at Indicated Time Points AST; Day 1; n= 18, 20, 20, 22, 22	14.9 IU/L Standard Deviation 5.58	14.2 IU/L Standard Deviation 5.19	17.2 IU/L Standard Deviation 12.31	14.4 IU/L Standard Deviation 5.85	13.6 IU/L Standard Deviation 3.63
Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (Alk. Phosph) Levels in Blood at Indicated Time Points AST; Day 15; n= 17, 20, 18, 22, 20	17.1 IU/L Standard Deviation 7.30	14.3 IU/L Standard Deviation 5.67	15.0 IU/L Standard Deviation 7.72	15.4 IU/L Standard Deviation 6.33	12.4 IU/L Standard Deviation 2.89
Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (Alk. Phosph) Levels in Blood at Indicated Time Points AST; Day 29; n= 17, 19, 18, 19, 17	26.8 IU/L Standard Deviation 30.04	13.8 IU/L Standard Deviation 5.01	16.0 IU/L Standard Deviation 8.44	15.0 IU/L Standard Deviation 6.35	13.5 IU/L Standard Deviation 3.12
Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (Alk. Phosph) Levels in Blood at Indicated Time Points AST; Day 43; n= 15, 20, 18, 21, 21	15.9 IU/L Standard Deviation 6.65	14.9 IU/L Standard Deviation 6.07	17.2 IU/L Standard Deviation 11.40	15.7 IU/L Standard Deviation 6.31	14.3 IU/L Standard Deviation 4.76
Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (Alk. Phosph) Levels in Blood at Indicated Time Points Alk. phosph; Day 1; n= 18, 20, 20, 22, 22	97.0 IU/L Standard Deviation 33.07	112.3 IU/L Standard Deviation 74.61	106.8 IU/L Standard Deviation 84.85	99.4 IU/L Standard Deviation 47.26	115.4 IU/L Standard Deviation 72.35
Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (Alk. Phosph) Levels in Blood at Indicated Time Points Alk. phosph; Day 15; n= 17, 20, 18, 22,20	102.4 IU/L Standard Deviation 34.70	115.4 IU/L Standard Deviation 73.37	114.5 IU/L Standard Deviation 82.29	101.5 IU/L Standard Deviation 56.44	110.0 IU/L Standard Deviation 62.65
Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (Alk. Phosph) Levels in Blood at Indicated Time Points Alk. phosph.; Day 29; n= 17, 19, 18, 19,17	94.1 IU/L Standard Deviation 35.07	120.2 IU/L Standard Deviation 81.15	109.2 IU/L Standard Deviation 83.14	93.5 IU/L Standard Deviation 42.92	120.4 IU/L Standard Deviation 67.51
Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (Alk. Phosph) Levels in Blood at Indicated Time Points Alk. phosph.; Day 43; n= 15, 20, 18, 21,21	96.5 IU/L Standard Deviation 34.12	117.6 IU/L Standard Deviation 76.61	113.8 IU/L Standard Deviation 78.69	116.2 IU/L Standard Deviation 96.02	108.6 IU/L Standard Deviation 50.49

SECONDARY outcome

Timeframe: Up to Day 43

Population: Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Serum bilirubin, direct bilirubin and indirect bilirubin levels were assessed as a clinical chemistry laboratory parameter from Baseline up to follow up visit at Day 43. Day 1 values were considered as Baseline values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Bilirubin, Direct Bilirubin and Indirect Bilirubin Levels in Blood at Indicated Time Points Bilirubin; Day 1; n= 18, 20, 20, 22, 22	6.6 Micromoles per liter (µmol/L) Standard Deviation 1.65	7.8 Micromoles per liter (µmol/L) Standard Deviation 3.11	6.6 Micromoles per liter (µmol/L) Standard Deviation 1.31	6.5 Micromoles per liter (µmol/L) Standard Deviation 1.10	7.2 Micromoles per liter (µmol/L) Standard Deviation 2.44
Bilirubin, Direct Bilirubin and Indirect Bilirubin Levels in Blood at Indicated Time Points Bilirubin; Day 15; n= 17, 20, 18, 22, 20	6.7 Micromoles per liter (µmol/L) Standard Deviation 3.08	7.1 Micromoles per liter (µmol/L) Standard Deviation 2.29	7.2 Micromoles per liter (µmol/L) Standard Deviation 2.67	6.5 Micromoles per liter (µmol/L) Standard Deviation 1.10	7.8 Micromoles per liter (µmol/L) Standard Deviation 2.24
Bilirubin, Direct Bilirubin and Indirect Bilirubin Levels in Blood at Indicated Time Points Bilirubin; Day 29; n= 17, 19, 18, 19, 17	6.8 Micromoles per liter (µmol/L) Standard Deviation 2.24	6.9 Micromoles per liter (µmol/L) Standard Deviation 1.93	7.6 Micromoles per liter (µmol/L) Standard Deviation 2.12	6.5 Micromoles per liter (µmol/L) Standard Deviation 1.47	7.8 Micromoles per liter (µmol/L) Standard Deviation 2.44
Bilirubin, Direct Bilirubin and Indirect Bilirubin Levels in Blood at Indicated Time Points Bilirubin; Day 43; n= 15, 20 ,18, 21, 21	6.0 Micromoles per liter (µmol/L) Standard Deviation 1.07	7.0 Micromoles per liter (µmol/L) Standard Deviation 2.38	7.2 Micromoles per liter (µmol/L) Standard Deviation 2.07	6.5 Micromoles per liter (µmol/L) Standard Deviation 1.25	7.5 Micromoles per liter (µmol/L) Standard Deviation 2.44
Bilirubin, Direct Bilirubin and Indirect Bilirubin Levels in Blood at Indicated Time Points Direct bilirubin; Day 1; n= 18, 20, 20, 22, 22	1.8 Micromoles per liter (µmol/L) Standard Deviation 1.17	1.9 Micromoles per liter (µmol/L) Standard Deviation 0.79	2.0 Micromoles per liter (µmol/L) Standard Deviation 1.12	1.9 Micromoles per liter (µmol/L) Standard Deviation 0.75	2.4 Micromoles per liter (µmol/L) Standard Deviation 1.33
Bilirubin, Direct Bilirubin and Indirect Bilirubin Levels in Blood at Indicated Time Points Direct bilirubin; Day 15; n= 17, 20, 18, 22, 20	1.5 Micromoles per liter (µmol/L) Standard Deviation 1.66	2.2 Micromoles per liter (µmol/L) Standard Deviation 0.62	2.4 Micromoles per liter (µmol/L) Standard Deviation 1.29	1.8 Micromoles per liter (µmol/L) Standard Deviation 0.85	2.6 Micromoles per liter (µmol/L) Standard Deviation 1.14
Bilirubin, Direct Bilirubin and Indirect Bilirubin Levels in Blood at Indicated Time Points Direct bilirubin; Day 29; n= 17, 19, 18, 19,17	2.5 Micromoles per liter (µmol/L) Standard Deviation 2.29	1.6 Micromoles per liter (µmol/L) Standard Deviation 1.07	2.7 Micromoles per liter (µmol/L) Standard Deviation 0.97	1.8 Micromoles per liter (µmol/L) Standard Deviation 0.63	2.4 Micromoles per liter (µmol/L) Standard Deviation 1.46
Bilirubin, Direct Bilirubin and Indirect Bilirubin Levels in Blood at Indicated Time Points Direct bilirubin; Day 43; n= 15, 20, 18, 21,21	1.3 Micromoles per liter (µmol/L) Standard Deviation 1.23	1.9 Micromoles per liter (µmol/L) Standard Deviation 0.45	2.3 Micromoles per liter (µmol/L) Standard Deviation 0.77	1.7 Micromoles per liter (µmol/L) Standard Deviation 0.72	2.3 Micromoles per liter (µmol/L) Standard Deviation 1.31
Bilirubin, Direct Bilirubin and Indirect Bilirubin Levels in Blood at Indicated Time Points Indirect bilirubin; Day 1; n= 18, 20, 20, 22, 22	4.8 Micromoles per liter (µmol/L) Standard Deviation 1.22	5.9 Micromoles per liter (µmol/L) Standard Deviation 2.94	4.6 Micromoles per liter (µmol/L) Standard Deviation 0.94	4.6 Micromoles per liter (µmol/L) Standard Deviation 1.14	4.8 Micromoles per liter (µmol/L) Standard Deviation 1.92
Bilirubin, Direct Bilirubin and Indirect Bilirubin Levels in Blood at Indicated Time Points Indirect bilirubin; Day 15; n= 17, 20, 18, 22, 20	5.2 Micromoles per liter (µmol/L) Standard Deviation 2.01	4.9 Micromoles per liter (µmol/L) Standard Deviation 2.10	4.8 Micromoles per liter (µmol/L) Standard Deviation 1.83	4.7 Micromoles per liter (µmol/L) Standard Deviation 0.98	5.2 Micromoles per liter (µmol/L) Standard Deviation 1.77
Bilirubin, Direct Bilirubin and Indirect Bilirubin Levels in Blood at Indicated Time Points Indirect bilirubin; Day 29; n= 17, 19, 18, 19, 17	4.4 Micromoles per liter (µmol/L) Standard Deviation 2.03	5.4 Micromoles per liter (µmol/L) Standard Deviation 1.64	4.9 Micromoles per liter (µmol/L) Standard Deviation 1.57	4.7 Micromoles per liter (µmol/L) Standard Deviation 1.52	5.4 Micromoles per liter (µmol/L) Standard Deviation 1.70
Bilirubin, Direct Bilirubin and Indirect Bilirubin Levels in Blood at Indicated Time Points Indirect bilirubin; Day 43; n= 15, 20, 18, 21, 21	4.7 Micromoles per liter (µmol/L) Standard Deviation 0.98	5.1 Micromoles per liter (µmol/L) Standard Deviation 2.38	4.9 Micromoles per liter (µmol/L) Standard Deviation 1.41	4.8 Micromoles per liter (µmol/L) Standard Deviation 1.48	5.2 Micromoles per liter (µmol/L) Standard Deviation 1.73

SECONDARY outcome

Timeframe: Baseline and up to Day 43

Population: Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Blood samples were collected from participants to evaluate clinical chemistry parameters including sodium, potassium, glucose, calcium and phosphate. Change from Baseline in clinical chemistry parameters at Day 15, Day 29 and Day 43 are presented. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Change From Baseline in Sodium, Potassium, Glucose, Calcium and Phosphate Levels Sodium; Day 15; n= 17, 20, 18, 22, 20	-0.9 Mmol/L Standard Deviation 2.73	-0.6 Mmol/L Standard Deviation 2.62	-0.5 Mmol/L Standard Deviation 2.64	-1.4 Mmol/L Standard Deviation 2.06	-1.0 Mmol/L Standard Deviation 2.13
Change From Baseline in Sodium, Potassium, Glucose, Calcium and Phosphate Levels Sodium; Day 29; n= 17, 19, 18, 19, 17	-1.1 Mmol/L Standard Deviation 2.26	-1.2 Mmol/L Standard Deviation 3.08	-0.9 Mmol/L Standard Deviation 2.26	-0.5 Mmol/L Standard Deviation 2.82	-1.2 Mmol/L Standard Deviation 2.70
Change From Baseline in Sodium, Potassium, Glucose, Calcium and Phosphate Levels Sodium; Day 43; n= 15, 20, 18, 21, 21	0.7 Mmol/L Standard Deviation 2.06	0.1 Mmol/L Standard Deviation 2.35	-0.6 Mmol/L Standard Deviation 2.28	-0.5 Mmol/L Standard Deviation 2.60	-0.6 Mmol/L Standard Deviation 2.23
Change From Baseline in Sodium, Potassium, Glucose, Calcium and Phosphate Levels Potassium; Day 15; n= 17, 20, 18, 22, 20	0.04 Mmol/L Standard Deviation 0.462	0.05 Mmol/L Standard Deviation 0.526	-0.09 Mmol/L Standard Deviation 1.099	0.03 Mmol/L Standard Deviation 0.944	-0.08 Mmol/L Standard Deviation 0.635
Change From Baseline in Sodium, Potassium, Glucose, Calcium and Phosphate Levels Potassium; Day 29; n= 17, 19, 18, 19, 17	0.20 Mmol/L Standard Deviation 0.744	0.05 Mmol/L Standard Deviation 0.660	-0.14 Mmol/L Standard Deviation 0.651	0.02 Mmol/L Standard Deviation 0.640	0.11 Mmol/L Standard Deviation 0.673
Change From Baseline in Sodium, Potassium, Glucose, Calcium and Phosphate Levels Potassium; Day 43; n= 15, 20, 18, 21, 21	0.04 Mmol/L Standard Deviation 0.565	-0.05 Mmol/L Standard Deviation 0.674	-0.06 Mmol/L Standard Deviation 1.004	-0.06 Mmol/L Standard Deviation 0.579	-0.02 Mmol/L Standard Deviation 0.932
Change From Baseline in Sodium, Potassium, Glucose, Calcium and Phosphate Levels Glucose; Day 15; n= 17, 20, 18, 22, 20	1.14 Mmol/L Standard Deviation 3.339	0.51 Mmol/L Standard Deviation 2.959	0.45 Mmol/L Standard Deviation 1.740	0.21 Mmol/L Standard Deviation 1.620	-0.03 Mmol/L Standard Deviation 2.364
Change From Baseline in Sodium, Potassium, Glucose, Calcium and Phosphate Levels Glucose; Day 29; n= 17, 19, 18, 19, 17	1.48 Mmol/L Standard Deviation 3.771	0.70 Mmol/L Standard Deviation 3.756	0.73 Mmol/L Standard Deviation 1.135	0.61 Mmol/L Standard Deviation 4.188	-0.36 Mmol/L Standard Deviation 3.786
Change From Baseline in Sodium, Potassium, Glucose, Calcium and Phosphate Levels Glucose; Day 43; n= 15, 20, 18, 21, 21	0.23 Mmol/L Standard Deviation 1.335	0.06 Mmol/L Standard Deviation 3.072	0.52 Mmol/L Standard Deviation 1.383	-0.81 Mmol/L Standard Deviation 2.516	-0.12 Mmol/L Standard Deviation 3.619
Change From Baseline in Sodium, Potassium, Glucose, Calcium and Phosphate Levels Calcium; Day 15; n= 17, 20, 18, 22, 20	-0.011 Mmol/L Standard Deviation 0.1227	-0.051 Mmol/L Standard Deviation 0.1354	-0.026 Mmol/L Standard Deviation 0.1439	-0.031 Mmol/L Standard Deviation 0.0956	-0.010 Mmol/L Standard Deviation 0.0912
Change From Baseline in Sodium, Potassium, Glucose, Calcium and Phosphate Levels Calcium; Day 29; n= 17, 19, 18, 19, 17	-0.054 Mmol/L Standard Deviation 0.1486	-0.025 Mmol/L Standard Deviation 0.1129	-0.009 Mmol/L Standard Deviation 0.1556	-0.012 Mmol/L Standard Deviation 0.0939	0.001 Mmol/L Standard Deviation 0.1019
Change From Baseline in Sodium, Potassium, Glucose, Calcium and Phosphate Levels Calcium; Day 43; n= 15, 20, 18, 21, 21	-0.015 Mmol/L Standard Deviation 0.1576	-0.035 Mmol/L Standard Deviation 0.1261	0.018 Mmol/L Standard Deviation 0.1852	0.001 Mmol/L Standard Deviation 0.0742	0.033 Mmol/L Standard Deviation 0.1489
Change From Baseline in Sodium, Potassium, Glucose, Calcium and Phosphate Levels Phosphate; Day 15; n= 17, 20, 18, 22, 20	-0.091 Mmol/L Standard Deviation 0.4051	0.183 Mmol/L Standard Deviation 0.5184	0.111 Mmol/L Standard Deviation 0.5715	0.030 Mmol/L Standard Deviation 0.3268	0.095 Mmol/L Standard Deviation 0.3367
Change From Baseline in Sodium, Potassium, Glucose, Calcium and Phosphate Levels Phosphate; Day 29; n= 17, 19, 18, 19, 17	0.091 Mmol/L Standard Deviation 0.3882	0.011 Mmol/L Standard Deviation 0.4932	0.069 Mmol/L Standard Deviation 0.4950	0.129 Mmol/L Standard Deviation 0.2740	-0.026 Mmol/L Standard Deviation 0.3653
Change From Baseline in Sodium, Potassium, Glucose, Calcium and Phosphate Levels Phosphate; Day 43; n= 15, 20, 18, 21, 21	-0.067 Mmol/L Standard Deviation 0.4337	-0.068 Mmol/L Standard Deviation 0.5324	-0.053 Mmol/L Standard Deviation 0.5400	0.102 Mmol/L Standard Deviation 0.3433	-0.117 Mmol/L Standard Deviation 0.5117

SECONDARY outcome

Timeframe: Baseline and up to Day 43

Population: Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Blood samples were collected from participants to evaluate clinical chemistry parameters including albumin and protein. Change from Baseline in clinical chemistry parameters at Day 15, Day 29 and Day 43 are presented. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Change From Baseline in Albumin and Protein Levels Protein; Day 29; n= 17, 19, 18, 19, 17	-1.1 g/L Standard Deviation 4.26	-0.8 g/L Standard Deviation 3.82	-1.2 g/L Standard Deviation 2.90	-1.0 g/L Standard Deviation 3.28	0.1 g/L Standard Deviation 2.56
Change From Baseline in Albumin and Protein Levels Protein; Day 43; n= 15, 20, 18, 21, 21	-0.1 g/L Standard Deviation 4.19	0.6 g/L Standard Deviation 4.38	-0.9 g/L Standard Deviation 3.17	0.3 g/L Standard Deviation 4.84	1.2 g/L Standard Deviation 3.95
Change From Baseline in Albumin and Protein Levels Albumin; Day 15; n= 17, 20, 18, 22, 20	0.8 g/L Standard Deviation 1.60	-0.5 g/L Standard Deviation 1.64	0.2 g/L Standard Deviation 2.24	-0.5 g/L Standard Deviation 1.44	-1.0 g/L Standard Deviation 2.34
Change From Baseline in Albumin and Protein Levels Albumin; Day 29; n= 17, 19, 18, 19, 17	-0.5 g/L Standard Deviation 2.24	-1.3 g/L Standard Deviation 2.03	-0.7 g/L Standard Deviation 2.00	-1.3 g/L Standard Deviation 1.85	-0.9 g/L Standard Deviation 1.76
Change From Baseline in Albumin and Protein Levels Albumin; Day 43; n= 15, 20, 18, 21, 21	0.1 g/L Standard Deviation 2.00	-0.6 g/L Standard Deviation 2.14	-0.7 g/L Standard Deviation 2.22	0.1 g/L Standard Deviation 3.85	-0.3 g/L Standard Deviation 1.74
Change From Baseline in Albumin and Protein Levels Protein; Day 15; n= 17, 20, 18, 22, 20	0.8 g/L Standard Deviation 2.97	-0.4 g/L Standard Deviation 3.25	0.3 g/L Standard Deviation 3.65	-0.7 g/L Standard Deviation 2.35	-1.5 g/L Standard Deviation 3.03

SECONDARY outcome

Timeframe: Baseline and up to Day 43

Population: Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Blood samples were collected from participants to evaluate clinical chemistry parameters including ALT, AST, Alk. phosph. Change from Baseline in clinical chemistry parameters at Day 15, Day 29 and Day 43 are presented. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Change From Baseline in ALT, AST, Alk. Phosph. Levels ALT; Day 15; n= 17, 20, 18, 22, 20	3.6 IU/L Standard Deviation 9.59	0.5 IU/L Standard Deviation 5.65	-3.1 IU/L Standard Deviation 5.53	1.1 IU/L Standard Deviation 4.79	-3.4 IU/L Standard Deviation 5.52
Change From Baseline in ALT, AST, Alk. Phosph. Levels ALT; Day 29; n= 17, 19, 18, 19, 17	11.8 IU/L Standard Deviation 32.39	-0.9 IU/L Standard Deviation 4.65	-3.4 IU/L Standard Deviation 9.83	-0.2 IU/L Standard Deviation 3.87	-3.6 IU/L Standard Deviation 4.72
Change From Baseline in ALT, AST, Alk. Phosph. Levels ALT; Day 43; n= 15, 20, 18, 21, 21	0.9 IU/L Standard Deviation 4.32	0.4 IU/L Standard Deviation 5.29	-2.5 IU/L Standard Deviation 8.97	2.2 IU/L Standard Deviation 4.08	-0.4 IU/L Standard Deviation 3.69
Change From Baseline in ALT, AST, Alk. Phosph. Levels AST; Day 15; n= 17, 20, 18, 22, 20	2.3 IU/L Standard Deviation 5.70	0.1 IU/L Standard Deviation 2.45	-2.7 IU/L Standard Deviation 6.29	1.0 IU/L Standard Deviation 5.26	-1.6 IU/L Standard Deviation 3.32
Change From Baseline in ALT, AST, Alk. Phosph. Levels AST; Day 29; n= 17, 19, 18, 19, 17	11.5 IU/L Standard Deviation 30.64	-0.3 IU/L Standard Deviation 3.30	-1.8 IU/L Standard Deviation 5.60	0.9 IU/L Standard Deviation 3.60	-0.3 IU/L Standard Deviation 3.67
Change From Baseline in ALT, AST, Alk. Phosph. Levels AST; Day 43; n= 15, 20, 18, 21, 21	0.6 IU/L Standard Deviation 3.94	0.7 IU/L Standard Deviation 2.49	-0.6 IU/L Standard Deviation 7.99	1.5 IU/L Standard Deviation 3.71	0.7 IU/L Standard Deviation 3.41
Change From Baseline in ALT, AST, Alk. Phosph. Levels Alk.phosph.; Day 15; n= 17, 20, 18, 22, 20	3.2 IU/L Standard Deviation 10.28	3.2 IU/L Standard Deviation 16.13	2.7 IU/L Standard Deviation 29.73	2.1 IU/L Standard Deviation 17.23	-4.7 IU/L Standard Deviation 18.90
Change From Baseline in ALT, AST, Alk. Phosph. Levels Alk.phosph.; Day 29; n= 17, 19, 18, 19, 17	-0.4 IU/L Standard Deviation 19.31	5.1 IU/L Standard Deviation 19.09	-0.9 IU/L Standard Deviation 30.13	0.9 IU/L Standard Deviation 13.47	-1.2 IU/L Standard Deviation 28.60
Change From Baseline in ALT, AST, Alk. Phosph. Levels Alk.phosph.; Day 43; n= 15, 20, 18, 21, 21	-1.5 IU/L Standard Deviation 17.01	5.4 IU/L Standard Deviation 21.34	2.7 IU/L Standard Deviation 31.96	18.0 IU/L Standard Deviation 66.44	-8.4 IU/L Standard Deviation 56.06

SECONDARY outcome

Timeframe: Baseline and up to Day 43

Population: Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the Daprodustat 25mg treatment group for all PK population and safety population analyses.

Blood samples were collected from participants to evaluate clinical chemistry parameters including bilirubin, direct bilirubin and indirect bilirubin. Change from Baseline in clinical chemistry parameters at Day 15, Day 29 and Day 43 are presented. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Change From Baseline in Bilirubin, Direct Bilirubin, Indirect Bilirubin Levels Bilirubin; Day 15; n= 17, 20, 18, 22, 20	0.2 µmol/L Standard Deviation 1.56	-0.7 µmol/L Standard Deviation 1.49	0.8 µmol/L Standard Deviation 2.07	0.0 µmol/L Standard Deviation 1.38	0.5 µmol/L Standard Deviation 1.93
Change From Baseline in Bilirubin, Direct Bilirubin, Indirect Bilirubin Levels Bilirubin; Day 29; n= 17, 19, 18, 19, 17	0.2 µmol/L Standard Deviation 0.97	-0.3 µmol/L Standard Deviation 1.20	1.0 µmol/L Standard Deviation 1.41	0.1 µmol/L Standard Deviation 1.56	0.2 µmol/L Standard Deviation 0.97
Change From Baseline in Bilirubin, Direct Bilirubin, Indirect Bilirubin Levels Bilirubin; Day 43; n= 15, 20, 18, 21, 21	-0.1 µmol/L Standard Deviation 0.52	-0.8 µmol/L Standard Deviation 1.51	0.6 µmol/L Standard Deviation 2.04	0.1 µmol/L Standard Deviation 1.34	0.4 µmol/L Standard Deviation 1.36
Change From Baseline in Bilirubin, Direct Bilirubin, Indirect Bilirubin Levels Direct bilirubin; Day 15; n= 17, 20, 18, 22, 20	-0.1 µmol/L Standard Deviation 1.11	0.3 µmol/L Standard Deviation 0.73	0.6 µmol/L Standard Deviation 0.92	-0.1 µmol/L Standard Deviation 0.97	0.2 µmol/L Standard Deviation 1.11
Change From Baseline in Bilirubin, Direct Bilirubin, Indirect Bilirubin Levels Direct bilirubin; Day 29; n= 17, 19, 18, 19, 17	0.7 µmol/L Standard Deviation 1.86	-0.3 µmol/L Standard Deviation 1.00	0.7 µmol/L Standard Deviation 0.97	-0.1 µmol/L Standard Deviation 1.05	-0.1 µmol/L Standard Deviation 1.50
Change From Baseline in Bilirubin, Direct Bilirubin, Indirect Bilirubin Levels Direct bilirubin; Day 43; n= 15, 20, 18, 21, 21	-0.1 µmol/L Standard Deviation 1.19	0.0 µmol/L Standard Deviation 0.92	0.3 µmol/L Standard Deviation 1.03	-0.2 µmol/L Standard Deviation 1.08	-0.1 µmol/L Standard Deviation 1.34
Change From Baseline in Bilirubin, Direct Bilirubin, Indirect Bilirubin Levels Indirect bilirubin; Day 15; n= 17, 20, 18, 22, 20	0.4 µmol/L Standard Deviation 1.46	-1.0 µmol/L Standard Deviation 1.38	0.2 µmol/L Standard Deviation 1.80	0.1 µmol/L Standard Deviation 1.44	0.3 µmol/L Standard Deviation 1.75
Change From Baseline in Bilirubin, Direct Bilirubin, Indirect Bilirubin Levels Indirect bilirubin; Day 29; n= 17, 19, 18, 19, 17	-0.5 µmol/L Standard Deviation 1.66	0.0 µmol/L Standard Deviation 1.15	0.3 µmol/L Standard Deviation 1.71	0.2 µmol/L Standard Deviation 1.62	0.4 µmol/L Standard Deviation 1.46
Change From Baseline in Bilirubin, Direct Bilirubin, Indirect Bilirubin Levels Indirect bilirubin; Day 43; n= 15, 20, 18, 21, 21	0.0 µmol/L Standard Deviation 1.07	-0.8 µmol/L Standard Deviation 1.64	0.2 µmol/L Standard Deviation 1.66	0.3 µmol/L Standard Deviation 1.82	0.5 µmol/L Standard Deviation 1.40

SECONDARY outcome

Timeframe: Up to Day 43

Population: Safety population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Serum leukocytes, neutrophils, basophils, eosinophils, lymphocytes, monocytes and platelet levels were assessed as a clinical hematology laboratory parameter from Baseline up to follow up visit at Day 43. Day 1 values were considered as Baseline values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Leukocytes; Day 1; n= 18, 19, 19, 20, 21	6.28 10^12 cells/L Standard Deviation 1.750	6.07 10^12 cells/L Standard Deviation 1.601	5.88 10^12 cells/L Standard Deviation 1.510	6.44 10^12 cells/L Standard Deviation 1.595	5.90 10^12 cells/L Standard Deviation 1.825
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Leukocytes; Day 15; n= 17, 19, 17, 21, 21	7.01 10^12 cells/L Standard Deviation 2.140	5.85 10^12 cells/L Standard Deviation 1.720	6.21 10^12 cells/L Standard Deviation 1.918	6.52 10^12 cells/L Standard Deviation 1.427	5.87 10^12 cells/L Standard Deviation 1.961
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Leukocytes; Day 29; n= 16, 19, 17, 18, 17	6.66 10^12 cells/L Standard Deviation 1.707	6.59 10^12 cells/L Standard Deviation 1.890	5.88 10^12 cells/L Standard Deviation 1.685	6.33 10^12 cells/L Standard Deviation 1.820	6.11 10^12 cells/L Standard Deviation 2.574
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Leukocytes; Day 43; n= 16, 20, 19, 20, 19	7.05 10^12 cells/L Standard Deviation 2.006	7.25 10^12 cells/L Standard Deviation 2.520	6.00 10^12 cells/L Standard Deviation 1.694	6.77 10^12 cells/L Standard Deviation 2.547	6.42 10^12 cells/L Standard Deviation 2.010
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Neutrophils; Day 1; n= 18, 19, 19, 20, 21	4.030 10^12 cells/L Standard Deviation 1.6128	4.097 10^12 cells/L Standard Deviation 1.5763	3.522 10^12 cells/L Standard Deviation 1.3492	3.954 10^12 cells/L Standard Deviation 1.4097	3.785 10^12 cells/L Standard Deviation 1.5024
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Neutrophils; Day 15; n= 17, 19, 17, 21, 21	4.666 10^12 cells/L Standard Deviation 1.8113	3.887 10^12 cells/L Standard Deviation 1.5659	3.707 10^12 cells/L Standard Deviation 1.6592	4.346 10^12 cells/L Standard Deviation 1.2240	4.129 10^12 cells/L Standard Deviation 1.6604
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Neutrophils; Day 29; n= 16, 18, 17, 17, 15	4.123 10^12 cells/L Standard Deviation 1.2229	4.591 10^12 cells/L Standard Deviation 1.9586	3.522 10^12 cells/L Standard Deviation 1.4546	3.978 10^12 cells/L Standard Deviation 1.7026	4.224 10^12 cells/L Standard Deviation 2.2017
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Neutrophils; Day 43; n= 16, 20, 19, 19, 19	4.687 10^12 cells/L Standard Deviation 1.8919	5.049 10^12 cells/L Standard Deviation 2.3848	3.545 10^12 cells/L Standard Deviation 1.4027	4.477 10^12 cells/L Standard Deviation 2.2480	4.343 10^12 cells/L Standard Deviation 1.6235
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Basophils; Day 1; n= 18, 19, 19, 20, 21	0.018 10^12 cells/L Standard Deviation 0.0131	0.016 10^12 cells/L Standard Deviation 0.0134	0.025 10^12 cells/L Standard Deviation 0.0174	0.028 10^12 cells/L Standard Deviation 0.0204	0.017 10^12 cells/L Standard Deviation 0.0142
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Basophils; Day 15; n= 17, 19, 17, 21, 21	0.027 10^12 cells/L Standard Deviation 0.0214	0.026 10^12 cells/L Standard Deviation 0.0161	0.022 10^12 cells/L Standard Deviation 0.0139	0.025 10^12 cells/L Standard Deviation 0.0325	0.024 10^12 cells/L Standard Deviation 0.0140
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Basophils; Day 29; n= 16, 18, 17, 17, 15	0.035 10^12 cells/L Standard Deviation 0.0462	0.021 10^12 cells/L Standard Deviation 0.0128	0.021 10^12 cells/L Standard Deviation 0.0150	0.024 10^12 cells/L Standard Deviation 0.0111	0.027 10^12 cells/L Standard Deviation 0.0315
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Basophils; Day 43; n= 16, 20, 19, 19, 19	0.028 10^12 cells/L Standard Deviation 0.0217	0.018 10^12 cells/L Standard Deviation 0.0136	0.020 10^12 cells/L Standard Deviation 0.0183	0.025 10^12 cells/L Standard Deviation 0.0204	0.024 10^12 cells/L Standard Deviation 0.0130
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Eosinophils; Day 1; n= 18, 19, 19, 20, 21	0.189 10^12 cells/L Standard Deviation 0.1946	0.174 10^12 cells/L Standard Deviation 0.1593	0.184 10^12 cells/L Standard Deviation 0.1696	0.196 10^12 cells/L Standard Deviation 0.2310	0.240 10^12 cells/L Standard Deviation 0.2115
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Eosinophils; Day 15; n= 17, 19, 17, 21, 21	0.161 10^12 cells/L Standard Deviation 0.1245	0.166 10^12 cells/L Standard Deviation 0.1804	0.192 10^12 cells/L Standard Deviation 0.2355	0.187 10^12 cells/L Standard Deviation 0.2186	0.186 10^12 cells/L Standard Deviation 0.1914
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Eosinophils; Day 29; n= 16, 18, 17, 17, 15	0.176 10^12 cells/L Standard Deviation 0.1917	0.149 10^12 cells/L Standard Deviation 0.0950	0.145 10^12 cells/L Standard Deviation 0.1136	0.237 10^12 cells/L Standard Deviation 0.2785	0.185 10^12 cells/L Standard Deviation 0.0798
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Eosinophils; Day 43; n= 16, 20, 19, 19, 19	0.216 10^12 cells/L Standard Deviation 0.2458	0.210 10^12 cells/L Standard Deviation 0.1969	0.232 10^12 cells/L Standard Deviation 0.2727	0.243 10^12 cells/L Standard Deviation 0.2670	0.217 10^12 cells/L Standard Deviation 0.1899
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Lymphocytes; Day 1; n= 18, 19, 19, 20, 21	1.631 10^12 cells/L Standard Deviation 0.4264	1.393 10^12 cells/L Standard Deviation 0.4587	1.739 10^12 cells/L Standard Deviation 0.6964	1.747 10^12 cells/L Standard Deviation 0.7325	1.442 10^12 cells/L Standard Deviation 0.4998
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Lymphocytes; Day 15; n= 17, 19, 17, 21, 21	1.735 10^12 cells/L Standard Deviation 0.6699	1.416 10^12 cells/L Standard Deviation 0.5670	1.842 10^12 cells/L Standard Deviation 0.7381	1.526 10^12 cells/L Standard Deviation 0.6697	1.206 10^12 cells/L Standard Deviation 0.4609
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Lymphocytes; Day 29; n= 16, 18, 17, 17, 15	1.870 10^12 cells/L Standard Deviation 0.7427	1.427 10^12 cells/L Standard Deviation 0.4187	1.775 10^12 cells/L Standard Deviation 0.6767	1.612 10^12 cells/L Standard Deviation 0.5775	1.181 10^12 cells/L Standard Deviation 0.3418
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Lymphocytes; Day 43; n= 16, 20, 19, 19, 19	1.648 10^12 cells/L Standard Deviation 0.5294	1.509 10^12 cells/L Standard Deviation 0.4386	1.736 10^12 cells/L Standard Deviation 0.3916	1.721 10^12 cells/L Standard Deviation 0.6644	1.399 10^12 cells/L Standard Deviation 0.5562
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Monocytes; Day 1; n= 18, 19, 20, 20, 21	0.401 10^12 cells/L Standard Deviation 0.1511	0.396 10^12 cells/L Standard Deviation 0.1591	0.435 10^12 cells/L Standard Deviation 0.2703	0.518 10^12 cells/L Standard Deviation 0.2077	0.421 10^12 cells/L Standard Deviation 0.1722
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Monocytes; Day 15; n= 17, 19, 17, 21, 21	0.420 10^12 cells/L Standard Deviation 0.2243	0.352 10^12 cells/L Standard Deviation 0.1457	0.436 10^12 cells/L Standard Deviation 0.2402	0.446 10^12 cells/L Standard Deviation 0.2085	0.384 10^12 cells/L Standard Deviation 0.2160
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Monocytes; Day 29; n= 16, 18, 17, 17, 15	0.444 10^12 cells/L Standard Deviation 0.2076	0.457 10^12 cells/L Standard Deviation 0.1503	0.403 10^12 cells/L Standard Deviation 0.1385	0.600 10^12 cells/L Standard Deviation 0.3465	0.426 10^12 cells/L Standard Deviation 0.2628
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Monocytes; Day 43; n= 16, 20, 19, 19, 19	0.461 10^12 cells/L Standard Deviation 0.1878	0.459 10^12 cells/L Standard Deviation 0.1916	0.461 10^12 cells/L Standard Deviation 0.2614	0.513 10^12 cells/L Standard Deviation 0.2739	0.429 10^12 cells/L Standard Deviation 0.2047
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Platelet; Day 1; n= 16, 19, 20, 19, 21	219.0 10^12 cells/L Standard Deviation 65.04	189.9 10^12 cells/L Standard Deviation 36.70	198.0 10^12 cells/L Standard Deviation 71.03	196.0 10^12 cells/L Standard Deviation 61.12	192.3 10^12 cells/L Standard Deviation 70.85
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Platelet; Day 15; n= 17, 18, 17, 20, 21	205.4 10^12 cells/L Standard Deviation 63.00	175.4 10^12 cells/L Standard Deviation 44.08	198.5 10^12 cells/L Standard Deviation 73.65	194.8 10^12 cells/L Standard Deviation 49.08	181.5 10^12 cells/L Standard Deviation 66.59
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Platelet; Day 29; n= 16, 19, 17, 17, 17	198.1 10^12 cells/L Standard Deviation 76.39	174.7 10^12 cells/L Standard Deviation 52.50	187.5 10^12 cells/L Standard Deviation 62.66	198.9 10^12 cells/L Standard Deviation 55.07	194.8 10^12 cells/L Standard Deviation 81.57
Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points Platelet; Day 43; n= 15, 20, 19, 21, 20	220.8 10^12 cells/L Standard Deviation 61.57	195.8 10^12 cells/L Standard Deviation 68.33	188.6 10^12 cells/L Standard Deviation 69.28	194.1 10^12 cells/L Standard Deviation 50.35	170.0 10^12 cells/L Standard Deviation 44.61

SECONDARY outcome

Timeframe: Up to Day 43

Population: Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Serum MCH levels were assessed as a clinical hematology laboratory parameter from Baseline up to follow up visit at Day 43. Day 1 values were considered as Baseline values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Mean Corpuscular Hemoglobin (MCH) Levels in Blood at Indicated Time Points Day 1; n= 18, 19, 20, 20, 21	31.19 Pg Standard Deviation 2.538	30.95 Pg Standard Deviation 1.889	30.19 Pg Standard Deviation 2.145	30.70 Pg Standard Deviation 1.781	31.46 Pg Standard Deviation 1.942
Mean Corpuscular Hemoglobin (MCH) Levels in Blood at Indicated Time Points Day 15; n= 17, 19, 17, 21, 21	30.83 Pg Standard Deviation 2.100	2.100 Pg Standard Deviation 1.866	30.74 Pg Standard Deviation 1.476	30.85 Pg Standard Deviation 1.619	31.70 Pg Standard Deviation 2.315
Mean Corpuscular Hemoglobin (MCH) Levels in Blood at Indicated Time Points Day 29; n= 16, 19, 17, 18, 17	30.97 Pg Standard Deviation 2.290	31.60 Pg Standard Deviation 2.194	30.56 Pg Standard Deviation 2.236	31.16 Pg Standard Deviation 1.729	31.68 Pg Standard Deviation 2.224
Mean Corpuscular Hemoglobin (MCH) Levels in Blood at Indicated Time Points Day 43; n= 16, 20, 19, 21, 20	30.86 Pg Standard Deviation 1.992	31.04 Pg Standard Deviation 1.870	30.49 Pg Standard Deviation 2.155	30.67 Pg Standard Deviation 1.846	31.84 Pg Standard Deviation 2.143

SECONDARY outcome

Timeframe: Up to Day 43

Population: Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Serum MCHC levels were assessed as a clinical hematology laboratory parameter from Baseline up to follow up visit at Day 43. Day 1 values were considered as Baseline values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Mean Corpuscular Hemoglobin Concentration (MCHC) Levels in Blood at Indicated Time Points Day 1; n= 18, 19, 20, 20, 21	322.9 g/L Standard Deviation 13.39	321.7 g/L Standard Deviation 12.61	319.5 g/L Standard Deviation 15.36	321.5 g/L Standard Deviation 12.91	327.6 g/L Standard Deviation 12.65
Mean Corpuscular Hemoglobin Concentration (MCHC) Levels in Blood at Indicated Time Points Day 15; n= 17, 19, 17, 21, 21	321.5 g/L Standard Deviation 11.22	324.0 g/L Standard Deviation 7.79	324.8 g/L Standard Deviation 8.35	318.3 g/L Standard Deviation 12.06	322.7 g/L Standard Deviation 14.75
Mean Corpuscular Hemoglobin Concentration (MCHC) Levels in Blood at Indicated Time Points Day 29; n= 16, 19, 17, 18, 17	323.3 g/L Standard Deviation 14.90	329.6 g/L Standard Deviation 12.61	325.4 g/L Standard Deviation 10.25	323.6 g/L Standard Deviation 8.61	323.9 g/L Standard Deviation 11.73
Mean Corpuscular Hemoglobin Concentration (MCHC) Levels in Blood at Indicated Time Points Day 43; n= 16, 20, 19, 21, 20	321.9 g/L Standard Deviation 13.22	325.2 g/L Standard Deviation 11.98	325.5 g/L Standard Deviation 11.23	321.0 g/L Standard Deviation 11.00	327.0 g/L Standard Deviation 10.66

SECONDARY outcome

Timeframe: Up to Day 43

Population: Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Serum MCV levels were assessed as a clinical hematology laboratory parameter from Baseline up to follow up visit at Day 43. Day 1 values were considered as Baseline values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Mean Corpuscular Volume (MCV) Levels in Blood at Indicated Time Points Day 1; n= 18, 19, 20, 20, 21	96.7 Femtoliter (fL) Standard Deviation 5.94	96.4 Femtoliter (fL) Standard Deviation 5.68	94.7 Femtoliter (fL) Standard Deviation 5.28	95.7 Femtoliter (fL) Standard Deviation 4.91	96.1 Femtoliter (fL) Standard Deviation 5.61
Mean Corpuscular Volume (MCV) Levels in Blood at Indicated Time Points Day 15; n= 17, 19, 17, 21, 21	95.9 Femtoliter (fL) Standard Deviation 6.02	95.8 Femtoliter (fL) Standard Deviation 6.27	94.8 Femtoliter (fL) Standard Deviation 4.53	97.0 Femtoliter (fL) Standard Deviation 6.41	98.3 Femtoliter (fL) Standard Deviation 5.57
Mean Corpuscular Volume (MCV) Levels in Blood at Indicated Time Points Day 29; n= 16, 19, 17, 18, 17	95.8 Femtoliter (fL) Standard Deviation 5.83	95.9 Femtoliter (fL) Standard Deviation 6.05	94.1 Femtoliter (fL) Standard Deviation 5.94	96.3 Femtoliter (fL) Standard Deviation 4.76	97.8 Femtoliter (fL) Standard Deviation 4.96
Mean Corpuscular Volume (MCV) Levels in Blood at Indicated Time Points Day 43; n= 16, 20, 19, 21, 20	96.1 Femtoliter (fL) Standard Deviation 5.91	95.4 Femtoliter (fL) Standard Deviation 5.08	93.7 Femtoliter (fL) Standard Deviation 6.09	95.6 Femtoliter (fL) Standard Deviation 5.27	97.5 Femtoliter (fL) Standard Deviation 5.98

SECONDARY outcome

Timeframe: Up to Day 43

Population: Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Erythrocyte distribution width levels were assessed as a clinical hematology laboratory parameter from Baseline up to follow up visit at Day 43. Day 1 values were considered as Baseline values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Erythrocyte Distribution Width Levels in Blood at Indicated Time Points Day 1; n= 18, 19, 20, 20, 21	15.13 Percentage of width Standard Deviation 2.607	16.40 Percentage of width Standard Deviation 2.082	15.41 Percentage of width Standard Deviation 1.627	15.81 Percentage of width Standard Deviation 2.504	15.68 Percentage of width Standard Deviation 1.725
Erythrocyte Distribution Width Levels in Blood at Indicated Time Points Day 15; n= 17, 19, 17, 21, 21	15.05 Percentage of width Standard Deviation 2.088	15.77 Percentage of width Standard Deviation 1.569	15.26 Percentage of width Standard Deviation 1.197	16.30 Percentage of width Standard Deviation 2.331	16.74 Percentage of width Standard Deviation 1.912
Erythrocyte Distribution Width Levels in Blood at Indicated Time Points Day 29; n= 16, 19, 17, 18, 17	15.15 Percentage of width Standard Deviation 2.530	15.69 Percentage of width Standard Deviation 1.750	15.36 Percentage of width Standard Deviation 1.287	15.76 Percentage of width Standard Deviation 1.253	16.23 Percentage of width Standard Deviation 1.668
Erythrocyte Distribution Width Levels in Blood at Indicated Time Points Day 43; n= 16, 20, 19, 21, 20	15.53 Percentage of width Standard Deviation 2.866	15.53 Percentage of width Standard Deviation 2.018	14.95 Percentage of width Standard Deviation 1.269	15.61 Percentage of width Standard Deviation 1.297	15.48 Percentage of width Standard Deviation 1.389

SECONDARY outcome

Timeframe: Baseline and up to Day 43

Population: Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Blood samples were collected from participants to evaluate clinical hematology parameters including MCH. Change from Baseline in clinical hematology parameters at Day 15, Day 29, Day 43 are presented. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Change From Baseline in MCH Levels Day 15; n= 17, 19, 17, 21, 21	0.16 Pg Standard Deviation 0.602	0.19 Pg Standard Deviation 0.817	0.27 Pg Standard Deviation 0.685	0.16 Pg Standard Deviation 0.520	0.25 Pg Standard Deviation 0.870
Change From Baseline in MCH Levels Day 29; n= 16, 19, 17, 18, 17	0.16 Pg Standard Deviation 0.982	0.58 Pg Standard Deviation 1.185	0.42 Pg Standard Deviation 0.824	0.41 Pg Standard Deviation 0.744	0.15 Pg Standard Deviation 0.987
Change From Baseline in MCH Levels Day 43; n= 16, 20, 19, 21, 20	0.11 Pg Standard Deviation 0.981	0.13 Pg Standard Deviation 0.948	0.34 Pg Standard Deviation 0.993	0.11 Pg Standard Deviation 0.842	0.29 Pg Standard Deviation 0.809

SECONDARY outcome

Timeframe: Baseline and up to Day 43

Population: Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Blood samples were collected from participants to evaluate clinical hematology parameters including MCHC. Change from Baseline in clinical hematology parameters at Day 15, Day 29, Day 43 are presented. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Change From Baseline in MCHC Levels Day 15; n= 17, 19, 17, 21, 21	2.6 g/L Standard Deviation 11.09	3.0 g/L Standard Deviation 14.21	3.5 g/L Standard Deviation 10.87	-3.2 g/L Standard Deviation 11.48	-5.0 g/L Standard Deviation 12.92
Change From Baseline in MCHC Levels Day 29; n= 16, 19, 17, 18, 17	5.6 g/L Standard Deviation 12.81	7.3 g/L Standard Deviation 16.92	7.6 g/L Standard Deviation 8.27	0.8 g/L Standard Deviation 10.04	-4.4 g/L Standard Deviation 12.30
Change From Baseline in MCHC Levels Day 43; n= 16, 20, 19, 21, 20	3.9 g/L Standard Deviation 15.92	3.0 g/L Standard Deviation 16.53	6.0 g/L Standard Deviation 11.44	-1.0 g/L Standard Deviation 12.12	-0.3 g/L Standard Deviation 9.14

SECONDARY outcome

Timeframe: Baseline and up to Day 43

Population: Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Blood samples were collected from participants to evaluate clinical hematology parameters including MCV. Change from Baseline in clinical hematology parameters at Day 15, Day 29, Day 43 are presented. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Change From Baseline in MCV Levels Day 15; n= 17, 19, 17, 21, 21	-0.4 fL Standard Deviation 2.98	-0.2 fL Standard Deviation 3.39	-0.3 fL Standard Deviation 2.57	1.3 fL Standard Deviation 3.15	2.2 fL Standard Deviation 3.21
Change From Baseline in MCV Levels Day 29; n= 16, 19, 17, 18, 17	-1.4 fL Standard Deviation 3.24	-0.5 fL Standard Deviation 2.86	-0.9 fL Standard Deviation 2.36	0.9 fL Standard Deviation 2.54	1.6 fL Standard Deviation 2.40
Change From Baseline in MCV Levels Day 43; n= 16, 20, 19, 21, 20	-0.8 fL Standard Deviation 3.15	-0.7 fL Standard Deviation 3.37	-0.8 fL Standard Deviation 3.28	0.6 fL Standard Deviation 3.06	0.9 fL Standard Deviation 2.10

SECONDARY outcome

Timeframe: Baseline and up to Day 43

Population: Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Blood samples were collected from participants to evaluate clinical hematology parameters including erythrocyte distribution width. Change from Baseline in clinical hematology parameters at Day 15, Day 29, Day 43 are presented. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Change From Baseline in Erythrocyte Distribution Width Levels Day 15; n= 17, 19, 17, 21, 21	-0.18 Percentage of width Standard Deviation 1.025	-0.48 Percentage of width Standard Deviation 1.276	-0.09 Percentage of width Standard Deviation 1.047	0.54 Percentage of width Standard Deviation 1.162	1.06 Percentage of width Standard Deviation 1.337
Change From Baseline in Erythrocyte Distribution Width Levels Day 29; n= 16, 19, 17, 18, 17	-0.31 Percentage of width Standard Deviation 1.019	-0.64 Percentage of width Standard Deviation 1.332	-0.23 Percentage of width Standard Deviation 1.021	0.58 Percentage of width Standard Deviation 1.202	0.40 Percentage of width Standard Deviation 1.342
Change From Baseline in Erythrocyte Distribution Width Levels Day 43; n= 16, 20, 19, 21, 20	0.18 Percentage of width Standard Deviation 1.329	-0.74 Percentage of width Standard Deviation 1.728	-0.50 Percentage of width Standard Deviation 1.094	0.23 Percentage of width Standard Deviation 1.410	-0.22 Percentage of width Standard Deviation 1.165

SECONDARY outcome

Timeframe: Baseline and up to Day 43

Population: Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Blood samples were collected from participants to evaluate clinical hematology parameters including leukocytes, neutrophils, basophils, eosinophils, lymphocytes, monocytes, platelets. Change from Baseline in clinical hematology parameters at Day 15, Day 29, Day 43 are presented. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Change From Baseline in Leukocytes, Neutrophils, Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Levels Leukocytes; Day 15; n= 17, 19, 17, 21, 21	0.47 10^12 cells/L Standard Deviation 1.271	-0.21 10^12 cells/L Standard Deviation 1.051	0.40 10^12 cells/L Standard Deviation 1.116	-0.03 10^12 cells/L Standard Deviation 1.476	-0.03 10^12 cells/L Standard Deviation 1.463
Change From Baseline in Leukocytes, Neutrophils, Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Levels Leukocytes; Day 29; n= 16, 19, 17, 18, 17	0.49 10^12 cells/L Standard Deviation 1.849	0.40 10^12 cells/L Standard Deviation 1.784	0.00 10^12 cells/L Standard Deviation 1.084	-0.14 10^12 cells/L Standard Deviation 1.701	0.20 10^12 cells/L Standard Deviation 1.526
Change From Baseline in Leukocytes, Neutrophils, Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Levels Leukocytes; Day 43; n= 16, 20, 19, 20, 19	0.54 10^12 cells/L Standard Deviation 1.041	1.08 10^12 cells/L Standard Deviation 1.662	0.23 10^12 cells/L Standard Deviation 1.101	0.21 10^12 cells/L Standard Deviation 2.615	0.67 10^12 cells/L Standard Deviation 1.580
Change From Baseline in Leukocytes, Neutrophils, Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Levels Neutrophils; Day 15; n= 17, 19, 17, 21, 21	0.391 10^12 cells/L Standard Deviation 1.2323	-0.146 10^12 cells/L Standard Deviation 0.9163	0.280 10^12 cells/L Standard Deviation 1.0681	0.259 10^12 cells/L Standard Deviation 1.3874	0.344 10^12 cells/L Standard Deviation 1.2469
Change From Baseline in Leukocytes, Neutrophils, Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Levels Neutrophils; Day 29; n= 16, 18, 17, 17, 15	0.237 10^12 cells/L Standard Deviation 1.6283	0.469 10^12 cells/L Standard Deviation 1.5717	-0.021 10^12 cells/L Standard Deviation 1.0157	-0.009 10^12 cells/L Standard Deviation 1.8718	0.273 10^12 cells/L Standard Deviation 1.5729
Change From Baseline in Leukocytes, Neutrophils, Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Levels Neutrophils; Day 43; n= 16, 20, 19, 19, 19	0.423 10^12 cells/L Standard Deviation 1.0535	0.904 10^12 cells/L Standard Deviation 1.3737	0.112 10^12 cells/L Standard Deviation 1.0449	0.504 10^12 cells/L Standard Deviation 2.3110	0.691 10^12 cells/L Standard Deviation 1.5221
Change From Baseline in Leukocytes, Neutrophils, Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Levels Basophils; Day 15; n= 17, 19, 17, 21, 21	0.005 10^12 cells/L Standard Deviation 0.0302	0.009 10^12 cells/L Standard Deviation 0.0200	-0.002 10^12 cells/L Standard Deviation 0.0210	-0.002 10^12 cells/L Standard Deviation 0.0383	0.007 10^12 cells/L Standard Deviation 0.0102
Change From Baseline in Leukocytes, Neutrophils, Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Levels Basophils; Day 29; n= 16, 18, 17, 17, 15	0.013 10^12 cells/L Standard Deviation 0.0510	0.006 10^12 cells/L Standard Deviation 0.0195	-0.004 10^12 cells/L Standard Deviation 0.0187	0.000 10^12 cells/L Standard Deviation 0.0242	0.012 10^12 cells/L Standard Deviation 0.0328
Change From Baseline in Leukocytes, Neutrophils, Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Levels Basophils; Day 43; n= 16, 20, 19, 19, 19	0.006 10^12 cells/L Standard Deviation 0.0268	0.001 10^12 cells/L Standard Deviation 0.0148	-0.004 10^12 cells/L Standard Deviation 0.0203	-0.001 10^12 cells/L Standard Deviation 0.0228	0.007 10^12 cells/L Standard Deviation 0.0192
Change From Baseline in Leukocytes, Neutrophils, Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Levels Eosinophils; Day 15; n= 17, 19, 17, 21, 21	0.009 10^12 cells/L Standard Deviation 0.0698	-0.017 10^12 cells/L Standard Deviation 0.1313	-0.006 10^12 cells/L Standard Deviation 0.1345	-0.006 10^12 cells/L Standard Deviation 0.1183	-0.053 10^12 cells/L Standard Deviation 0.1478
Change From Baseline in Leukocytes, Neutrophils, Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Levels Eosinophils; Day 29; n= 16, 18, 17, 17, 15	0.020 10^12 cells/L Standard Deviation 0.0859	-0.002 10^12 cells/L Standard Deviation 0.1226	-0.006 10^12 cells/L Standard Deviation 0.1129	0.025 10^12 cells/L Standard Deviation 0.0990	0.007 10^12 cells/L Standard Deviation 0.0880
Change From Baseline in Leukocytes, Neutrophils, Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Levels Eosinophils; Day 43; n= 16, 20, 19, 19, 19	0.061 10^12 cells/L Standard Deviation 0.1193	0.030 10^12 cells/L Standard Deviation 0.1439	0.051 10^12 cells/L Standard Deviation 0.1647	0.021 10^12 cells/L Standard Deviation 0.0984	-0.024 10^12 cells/L Standard Deviation 0.1876
Change From Baseline in Leukocytes, Neutrophils, Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Levels Lymphocytes; Day 15; n= 17, 19, 17, 21, 21	0.082 10^12 cells/L Standard Deviation 0.4256	-0.019 10^12 cells/L Standard Deviation 0.3163	0.106 10^12 cells/L Standard Deviation 0.4617	-0.208 10^12 cells/L Standard Deviation 0.5095	-0.236 10^12 cells/L Standard Deviation 0.4298
Change From Baseline in Leukocytes, Neutrophils, Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Levels Lymphocytes; Day 29; n= 16, 18, 17, 17, 15	0.194 10^12 cells/L Standard Deviation 0.6605	0.026 10^12 cells/L Standard Deviation 0.4130	0.019 10^12 cells/L Standard Deviation 0.4421	-0.074 10^12 cells/L Standard Deviation 0.7018	-0.154 10^12 cells/L Standard Deviation 0.3058
Change From Baseline in Leukocytes, Neutrophils, Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Levels Lymphocytes; Day 43; n= 16, 20, 19, 19, 19	0.018 10^12 cells/L Standard Deviation 0.3427	0.061 10^12 cells/L Standard Deviation 0.3332	0.007 10^12 cells/L Standard Deviation 0.4824	-0.064 10^12 cells/L Standard Deviation 0.4759	-0.041 10^12 cells/L Standard Deviation 0.2801
Change From Baseline in Leukocytes, Neutrophils, Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Levels Monocytes; Day 15; n= 17, 19, 17, 21, 21	-0.005 10^12 cells/L Standard Deviation 0.1518	-0.042 10^12 cells/L Standard Deviation 0.1504	-0.016 10^12 cells/L Standard Deviation 0.2285	-0.068 10^12 cells/L Standard Deviation 0.1895	-0.037 10^12 cells/L Standard Deviation 0.1460
Change From Baseline in Leukocytes, Neutrophils, Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Levels Monocytes; Day 29; n= 16, 18, 17, 17, 15	0.027 10^12 cells/L Standard Deviation 0.1553	0.053 10^12 cells/L Standard Deviation 0.1483	-0.031 10^12 cells/L Standard Deviation 0.2194	0.077 10^12 cells/L Standard Deviation 0.2532	0.015 10^12 cells/L Standard Deviation 0.1878
Change From Baseline in Leukocytes, Neutrophils, Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Levels Monocytes; Day 43; n= 16, 20, 19, 19, 19	0.033 10^12 cells/L Standard Deviation 0.1631	0.065 10^12 cells/L Standard Deviation 0.1629	0.026 10^12 cells/L Standard Deviation 0.2652	-0.021 10^12 cells/L Standard Deviation 0.1855	0.023 10^12 cells/L Standard Deviation 0.1249
Change From Baseline in Leukocytes, Neutrophils, Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Levels Platelet; Day 15; n= 17, 18, 17, 20, 21	-14.2 10^12 cells/L Standard Deviation 26.24	-16.2 10^12 cells/L Standard Deviation 27.46	-3.2 10^12 cells/L Standard Deviation 38.13	-3.3 10^12 cells/L Standard Deviation 27.78	-10.8 10^12 cells/L Standard Deviation 31.95
Change From Baseline in Leukocytes, Neutrophils, Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Levels Platelet; Day 29; n= 16, 18, 17, 17, 17	-17.1 10^12 cells/L Standard Deviation 40.58	-12.8 10^12 cells/L Standard Deviation 36.55	-18.1 10^12 cells/L Standard Deviation 29.63	1.3 10^12 cells/L Standard Deviation 35.58	-2.4 10^12 cells/L Standard Deviation 33.65
Change From Baseline in Leukocytes, Neutrophils, Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Levels Platelet; Day 43; n= 15, 19, 19, 21, 20	-4.9 10^12 cells/L Standard Deviation 37.30	4.4 10^12 cells/L Standard Deviation 50.34	-10.4 10^12 cells/L Standard Deviation 35.12	-1.6 10^12 cells/L Standard Deviation 30.95	-7.1 10^12 cells/L Standard Deviation 31.95

SECONDARY outcome

Timeframe: Up to Day 29

Population: Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Single measurements of 12-lead ECG were obtained in supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT interval. Number of participants who had abnormal non clinically significant (NCS) and abnormal clinically significant (CS) ECG findings at Baseline (Week -4) and Day 29 are presented.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Number of Participants With Abnormal Electrocardiogram (ECG) Findings at Indicated Time Points Baseline(Week-4);Abnormal;CS;n=19,20,20,22,22	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings at Indicated Time Points Baseline(Week -4);Abnormal; NCS;n=19,20,20,22,22	10 Participants	15 Participants	18 Participants	12 Participants	16 Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings at Indicated Time Points Day 29; Abnormal; NCS; n=17,19,18,19,17	12 Participants	14 Participants	16 Participants	8 Participants	12 Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings at Indicated Time Points Day 29; Abnormal; CS; n=17,19,18,19,17	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: Safety Population

Single measurements of 12-lead ECG were obtained in supine position using an ECG machine to measure HR. Week -4 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values at Day 29 minus Baseline value.

Outcome measures

Outcome measures
Measure	Placebo n=17 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=19 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=18 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=19 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=17 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Change From Baseline in ECG Mean Heart Rate	-2.0 Beats per minute Standard Deviation 8.66	0.5 Beats per minute Standard Deviation 10.53	1.1 Beats per minute Standard Deviation 7.40	2.2 Beats per minute Standard Deviation 7.51	0.9 Beats per minute Standard Deviation 7.09

SECONDARY outcome

Timeframe: Baseline and Day 29

Population: Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Single measurements of 12-lead ECG were obtained in supine position using an ECG machine to measure PR interval, QRS duration, QT interval and QTcB. Week -4 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values at Day 29 minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Change From Baseline in ECG Parameters Including PR Interval, QRS Duration, QT Interval and QTcB PR interval; n= 17, 18, 18, 17, 16	7.8 Milliseconds (msec) Standard Deviation 16.86	7.3 Milliseconds (msec) Standard Deviation 12.37	-3.3 Milliseconds (msec) Standard Deviation 23.04	2.1 Milliseconds (msec) Standard Deviation 27.13	-11.5 Milliseconds (msec) Standard Deviation 24.77
Change From Baseline in ECG Parameters Including PR Interval, QRS Duration, QT Interval and QTcB QRS duration; n= 17, 19, 18, 19, 17	-1.4 Milliseconds (msec) Standard Deviation 14.05	-5.7 Milliseconds (msec) Standard Deviation 13.36	-4.7 Milliseconds (msec) Standard Deviation 47.01	1.7 Milliseconds (msec) Standard Deviation 14.33	2.5 Milliseconds (msec) Standard Deviation 8.97
Change From Baseline in ECG Parameters Including PR Interval, QRS Duration, QT Interval and QTcB QT interval; n= 17, 19, 18, 19, 17	10.5 Milliseconds (msec) Standard Deviation 27.16	0.7 Milliseconds (msec) Standard Deviation 31.11	-19.2 Milliseconds (msec) Standard Deviation 62.37	-1.4 Milliseconds (msec) Standard Deviation 17.72	-8.2 Milliseconds (msec) Standard Deviation 33.24
Change From Baseline in ECG Parameters Including PR Interval, QRS Duration, QT Interval and QTcB QTcB; n= 17, 19, 18, 19, 17	0.0 Milliseconds (msec) Standard Deviation 30.84	5.6 Milliseconds (msec) Standard Deviation 17.40	-3.7 Milliseconds (msec) Standard Deviation 44.86	1.1 Milliseconds (msec) Standard Deviation 20.84	-5.7 Milliseconds (msec) Standard Deviation 31.65

SECONDARY outcome

Timeframe: Up to Day 43

Population: Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Vital sign measurements including SBP and DBP were taken in a seated or semi-supine position in the dialysis chair at specific time points. SBP and DBP were measured pre-dialysis and post-dialysis. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Values at Pre-dialysis and Post-dialysis DBP; pre-dialysis; Day 29; n= 17, 19, 18, 19, 17	70.4 Millimeter of mercury (mmHg) Standard Deviation 15.43	63.5 Millimeter of mercury (mmHg) Standard Deviation 13.55	70.9 Millimeter of mercury (mmHg) Standard Deviation 12.86	73.3 Millimeter of mercury (mmHg) Standard Deviation 13.17	72.7 Millimeter of mercury (mmHg) Standard Deviation 9.96
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Values at Pre-dialysis and Post-dialysis DBP; pre-dialysis; Day 43; n= 16, 20, 19, 21, 21	72.5 Millimeter of mercury (mmHg) Standard Deviation 14.73	66.8 Millimeter of mercury (mmHg) Standard Deviation 11.94	69.9 Millimeter of mercury (mmHg) Standard Deviation 13.54	77.9 Millimeter of mercury (mmHg) Standard Deviation 16.03	72.8 Millimeter of mercury (mmHg) Standard Deviation 10.52
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Values at Pre-dialysis and Post-dialysis SBP; pre-dialysis; Day 1; n= 19, 20, 20, 22, 22	142.5 Millimeter of mercury (mmHg) Standard Deviation 22.15	136.6 Millimeter of mercury (mmHg) Standard Deviation 15.39	149.2 Millimeter of mercury (mmHg) Standard Deviation 26.36	144.1 Millimeter of mercury (mmHg) Standard Deviation 24.27	144.1 Millimeter of mercury (mmHg) Standard Deviation 17.01
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Values at Pre-dialysis and Post-dialysis DBP; pre-dialysis; Day 15; n= 17, 20, 18, 22, 21	72.5 Millimeter of mercury (mmHg) Standard Deviation 17.76	70.0 Millimeter of mercury (mmHg) Standard Deviation 11.92	70.1 Millimeter of mercury (mmHg) Standard Deviation 10.50	73.5 Millimeter of mercury (mmHg) Standard Deviation 13.69	69.7 Millimeter of mercury (mmHg) Standard Deviation 12.43
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Values at Pre-dialysis and Post-dialysis SBP; pre-dialysis; Day 15; n= 17, 20, 18, 22, 21	138.8 Millimeter of mercury (mmHg) Standard Deviation 24.12	138.3 Millimeter of mercury (mmHg) Standard Deviation 16.14	139.0 Millimeter of mercury (mmHg) Standard Deviation 22.77	146.6 Millimeter of mercury (mmHg) Standard Deviation 20.75	142.3 Millimeter of mercury (mmHg) Standard Deviation 14.90
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Values at Pre-dialysis and Post-dialysis SBP; pre-dialysis; Day 29; n= 17, 19, 18, 19, 17	143.0 Millimeter of mercury (mmHg) Standard Deviation 22.08	133.1 Millimeter of mercury (mmHg) Standard Deviation 18.65	143.1 Millimeter of mercury (mmHg) Standard Deviation 23.21	144.2 Millimeter of mercury (mmHg) Standard Deviation 23.27	148.7 Millimeter of mercury (mmHg) Standard Deviation 19.17
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Values at Pre-dialysis and Post-dialysis SBP; pre-dialysis; Day 43; n= 16, 20, 19, 21, 21	140.0 Millimeter of mercury (mmHg) Standard Deviation 22.01	137.9 Millimeter of mercury (mmHg) Standard Deviation 13.21	142.0 Millimeter of mercury (mmHg) Standard Deviation 24.23	149.0 Millimeter of mercury (mmHg) Standard Deviation 23.32	147.1 Millimeter of mercury (mmHg) Standard Deviation 19.18
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Values at Pre-dialysis and Post-dialysis DBP; pre-dialysis; Day 1; n= 19, 20, 20, 22, 22	71.9 Millimeter of mercury (mmHg) Standard Deviation 14.84	68.8 Millimeter of mercury (mmHg) Standard Deviation 11.02	73.3 Millimeter of mercury (mmHg) Standard Deviation 12.96	71.8 Millimeter of mercury (mmHg) Standard Deviation 14.38	72.2 Millimeter of mercury (mmHg) Standard Deviation 13.64
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Values at Pre-dialysis and Post-dialysis SBP; post-dialysis; Day 1; n= 19, 20, 20, 22, 22	138.6 Millimeter of mercury (mmHg) Standard Deviation 18.57	137.0 Millimeter of mercury (mmHg) Standard Deviation 22.10	139.9 Millimeter of mercury (mmHg) Standard Deviation 22.24	136.7 Millimeter of mercury (mmHg) Standard Deviation 21.15	140.1 Millimeter of mercury (mmHg) Standard Deviation 20.10
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Values at Pre-dialysis and Post-dialysis SBP; post-dialysis; Day 15; n= 17, 20, 18, 22, 21	138.6 Millimeter of mercury (mmHg) Standard Deviation 21.83	135.5 Millimeter of mercury (mmHg) Standard Deviation 21.63	137.7 Millimeter of mercury (mmHg) Standard Deviation 23.02	137.4 Millimeter of mercury (mmHg) Standard Deviation 17.58	140.9 Millimeter of mercury (mmHg) Standard Deviation 15.34
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Values at Pre-dialysis and Post-dialysis SBP; post-dialysis; Day 29; n= 17, 19, 18, 19, 17	135.7 Millimeter of mercury (mmHg) Standard Deviation 26.04	130.1 Millimeter of mercury (mmHg) Standard Deviation 18.50	133.7 Millimeter of mercury (mmHg) Standard Deviation 23.88	142.8 Millimeter of mercury (mmHg) Standard Deviation 23.96	147.8 Millimeter of mercury (mmHg) Standard Deviation 19.09
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Values at Pre-dialysis and Post-dialysis SBP; post-dialysis; Day 43; n= 16, 20, 19, 21, 21	137.5 Millimeter of mercury (mmHg) Standard Deviation 22.74	135.8 Millimeter of mercury (mmHg) Standard Deviation 21.05	130.4 Millimeter of mercury (mmHg) Standard Deviation 15.47	145.2 Millimeter of mercury (mmHg) Standard Deviation 20.66	137.5 Millimeter of mercury (mmHg) Standard Deviation 22.74
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Values at Pre-dialysis and Post-dialysis DBP; post-dialysis; Day 1; n= 19, 20, 20, 22, 22	72.1 Millimeter of mercury (mmHg) Standard Deviation 15.11	67.9 Millimeter of mercury (mmHg) Standard Deviation 11.49	68.7 Millimeter of mercury (mmHg) Standard Deviation 11.64	71.1 Millimeter of mercury (mmHg) Standard Deviation 12.92	71.5 Millimeter of mercury (mmHg) Standard Deviation 11.17
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Values at Pre-dialysis and Post-dialysis DBP; post-dialysis; Day 15; n= 17, 20, 18, 22, 21	72.4 Millimeter of mercury (mmHg) Standard Deviation 16.41	70.1 Millimeter of mercury (mmHg) Standard Deviation 12.84	67.8 Millimeter of mercury (mmHg) Standard Deviation 11.10	71.3 Millimeter of mercury (mmHg) Standard Deviation 11.07	71.1 Millimeter of mercury (mmHg) Standard Deviation 9.51
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Values at Pre-dialysis and Post-dialysis DBP; post-dialysis; Day 29; n= 17, 19, 18, 19, 17	73.9 Millimeter of mercury (mmHg) Standard Deviation 15.11	64.4 Millimeter of mercury (mmHg) Standard Deviation 9.83	67.9 Millimeter of mercury (mmHg) Standard Deviation 12.00	72.4 Millimeter of mercury (mmHg) Standard Deviation 12.43	72.9 Millimeter of mercury (mmHg) Standard Deviation 11.18
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Values at Pre-dialysis and Post-dialysis DBP; post-dialysis; Day 43; n= 16, 20, 19, 21, 21	69.5 Millimeter of mercury (mmHg) Standard Deviation 15.24	67.4 Millimeter of mercury (mmHg) Standard Deviation 10.90	67.4 Millimeter of mercury (mmHg) Standard Deviation 11.24	72.9 Millimeter of mercury (mmHg) Standard Deviation 12.60	75.3 Millimeter of mercury (mmHg) Standard Deviation 7.89

SECONDARY outcome

Timeframe: Up to Day 43

Population: Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Vital sign measurements including pulse rate values were taken in a seated or semi-supine position in the dialysis chair. Pulse rate was measured pre-dialysis and post-dialysis. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Pulse Rate Values at Pre-dialysis and Post-dialysis Pre-dialysis; Day 1; n= 19, 20, 20, 22, 22	68.5 Beats per minute Standard Deviation 7.95	69.9 Beats per minute Standard Deviation 9.18	66.7 Beats per minute Standard Deviation 7.01	71.4 Beats per minute Standard Deviation 11.25	76.5 Beats per minute Standard Deviation 9.35
Pulse Rate Values at Pre-dialysis and Post-dialysis Pre-dialysis; Day 15; n= 17, 20, 18, 22, 21	76.1 Beats per minute Standard Deviation 10.31	67.3 Beats per minute Standard Deviation 9.20	68.3 Beats per minute Standard Deviation 7.51	72.1 Beats per minute Standard Deviation 11.89	75.1 Beats per minute Standard Deviation 12.68
Pulse Rate Values at Pre-dialysis and Post-dialysis Pre-dialysis; Day 29; n= 17, 19, 18, 19, 17	70.4 Beats per minute Standard Deviation 8.31	70.3 Beats per minute Standard Deviation 11.54	69.6 Beats per minute Standard Deviation 9.53	70.8 Beats per minute Standard Deviation 9.91	73.4 Beats per minute Standard Deviation 11.45
Pulse Rate Values at Pre-dialysis and Post-dialysis Pre-dialysis; Day 43; n= 16, 20, 19, 21, 21	71.5 Beats per minute Standard Deviation 9.17	69.9 Beats per minute Standard Deviation 9.34	66.9 Beats per minute Standard Deviation 6.74	71.3 Beats per minute Standard Deviation 10.08	75.8 Beats per minute Standard Deviation 8.29
Pulse Rate Values at Pre-dialysis and Post-dialysis Post-dialysis; Day 1; n= 19, 20, 20, 22, 22	71.0 Beats per minute Standard Deviation 11.54	68.7 Beats per minute Standard Deviation 11.19	66.3 Beats per minute Standard Deviation 8.37	73.2 Beats per minute Standard Deviation 12.77	78.8 Beats per minute Standard Deviation 11.61
Pulse Rate Values at Pre-dialysis and Post-dialysis Post-dialysis; Day 15; n= 17, 20, 18, 22, 21	72.5 Beats per minute Standard Deviation 12.69	67.7 Beats per minute Standard Deviation 12.24	70.1 Beats per minute Standard Deviation 12.49	73.0 Beats per minute Standard Deviation 12.07	78.1 Beats per minute Standard Deviation 15.72
Pulse Rate Values at Pre-dialysis and Post-dialysis Post-dialysis; Day 29; n= 17, 19, 18, 19, 17	73.6 Beats per minute Standard Deviation 7.10	69.9 Beats per minute Standard Deviation 9.60	68.8 Beats per minute Standard Deviation 11.29	72.2 Beats per minute Standard Deviation 9.52	77.4 Beats per minute Standard Deviation 10.04
Pulse Rate Values at Pre-dialysis and Post-dialysis Post-dialysis; Day 43; n= 16, 20, 19, 21, 21	72.0 Beats per minute Standard Deviation 12.04	69.1 Beats per minute Standard Deviation 10.21	68.0 Beats per minute Standard Deviation 10.28	71.9 Beats per minute Standard Deviation 11.02	77.3 Beats per minute Standard Deviation 10.26

SECONDARY outcome

Timeframe: Up to Day 43

Population: Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Vital sign measurements including weight values were taken in a seated or semi-supine position in the dialysis chair. Weight was measured post-dialysis. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Weight Values at Post-dialysis Day 29; n= 17, 19, 18, 19, 17	83.22 Kilograms (kg) Standard Deviation 27.198	81.04 Kilograms (kg) Standard Deviation 25.925	80.02 Kilograms (kg) Standard Deviation 22.286	82.66 Kilograms (kg) Standard Deviation 23.036	76.07 Kilograms (kg) Standard Deviation 18.135
Weight Values at Post-dialysis Day 1; n= 19, 20, 20, 22, 22	82.38 Kilograms (kg) Standard Deviation 25.941	80.04 Kilograms (kg) Standard Deviation 25.996	78.83 Kilograms (kg) Standard Deviation 21.331	79.38 Kilograms (kg) Standard Deviation 23.345	76.03 Kilograms (kg) Standard Deviation 16.877
Weight Values at Post-dialysis Day 15; n= 17, 20, 18, 22, 21	84.24 Kilograms (kg) Standard Deviation 26.652	80.00 Kilograms (kg) Standard Deviation 25.887	79.82 Kilograms (kg) Standard Deviation 22.200	79.44 Kilograms (kg) Standard Deviation 23.500	75.55 Kilograms (kg) Standard Deviation 17.595
Weight Values at Post-dialysis Day 43; n= 16, 20, 19, 21, 21	83.93 Kilograms (kg) Standard Deviation 27.589	80.21 Kilograms (kg) Standard Deviation 26.683	79.25 Kilograms (kg) Standard Deviation 21.757	80.64 Kilograms (kg) Standard Deviation 23.347	73.66 Kilograms (kg) Standard Deviation 11.614

SECONDARY outcome

Timeframe: Up to Day 43

Population: Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Vital sign measurements including SBP and DBP were taken in a seated or semi-supine position in the dialysis chair. SBP and DBP were measured pre-dialysis and post-dialysis. Pre-dialysis Baseline value was defined as SBP and DBP value obtained pre-dialysis on Day 1. Post-dialysis Baseline value was defined as SBP and DBP value obtained post-dialysis at Week -2. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Change From Baseline in SBP and DBP Values at Pre-dialysis and Post-dialysis SBP; pre-dialysis; Day 15; n= 17, 20, 18, 22, 21	-2.9 mmHg Standard Deviation 22.03	1.7 mmHg Standard Deviation 14.14	-5.6 mmHg Standard Deviation 14.77	2.5 mmHg Standard Deviation 20.68	-1.4 mmHg Standard Deviation 16.35
Change From Baseline in SBP and DBP Values at Pre-dialysis and Post-dialysis SBP; pre-dialysis; Day 29; n= 17, 19, 18, 19, 17	-0.6 mmHg Standard Deviation 20.32	-3.9 mmHg Standard Deviation 19.72	-4.7 mmHg Standard Deviation 18.17	1.3 mmHg Standard Deviation 17.51	4.5 mmHg Standard Deviation 20.03
Change From Baseline in SBP and DBP Values at Pre-dialysis and Post-dialysis SBP; pre-dialysis; Day 43; n= 16, 20, 19, 21, 21	-2.1 mmHg Standard Deviation 21.34	1.2 mmHg Standard Deviation 17.14	-6.2 mmHg Standard Deviation 13.83	3.3 mmHg Standard Deviation 19.47	4.3 mmHg Standard Deviation 10.03
Change From Baseline in SBP and DBP Values at Pre-dialysis and Post-dialysis SBP; post-dialysis; Day 15; n= 17, 20, 18, 22, 21	5.4 mmHg Standard Deviation 21.39	-3.6 mmHg Standard Deviation 20.13	6.1 mmHg Standard Deviation 20.81	5.7 mmHg Standard Deviation 21.07	-0.7 mmHg Standard Deviation 22.33
Change From Baseline in SBP and DBP Values at Pre-dialysis and Post-dialysis SBP; post-dialysis; Day 29; n= 17, 19, 18, 19, 17	2.3 mmHg Standard Deviation 19.72	-9.4 mmHg Standard Deviation 18.50	0.8 mmHg Standard Deviation 24.79	9.3 mmHg Standard Deviation 19.03	4.0 mmHg Standard Deviation 19.76
Change From Baseline in SBP and DBP Values at Pre-dialysis and Post-dialysis SBP; post-dialysis; Day 43; n= 16, 20, 19, 21, 21	3.1 mmHg Standard Deviation 22.22	-3.2 mmHg Standard Deviation 21.71	-3.6 mmHg Standard Deviation 17.88	12.0 mmHg Standard Deviation 20.19	4.7 mmHg Standard Deviation 20.11
Change From Baseline in SBP and DBP Values at Pre-dialysis and Post-dialysis DBP; pre-dialysis; Day 15; n= 17, 20, 18, 22, 21	1.1 mmHg Standard Deviation 10.57	1.2 mmHg Standard Deviation 8.85	-1.7 mmHg Standard Deviation 9.78	1.8 mmHg Standard Deviation 12.68	-2.1 mmHg Standard Deviation 11.04
Change From Baseline in SBP and DBP Values at Pre-dialysis and Post-dialysis DBP; pre-dialysis; Day 29; n= 17, 19, 18, 19, 17	-0.3 mmHg Standard Deviation 11.09	-4.7 mmHg Standard Deviation 10.04	-3.0 mmHg Standard Deviation 8.99	1.4 mmHg Standard Deviation 10.50	-0.1 mmHg Standard Deviation 13.80
Change From Baseline in SBP and DBP Values at Pre-dialysis and Post-dialysis DBP; pre-dialysis; Day 43; n= 16, 20, 19, 21, 21	2.2 mmHg Standard Deviation 8.80	-2.0 mmHg Standard Deviation 9.47	-3.1 mmHg Standard Deviation 11.06	5.2 mmHg Standard Deviation 15.08	2.1 mmHg Standard Deviation 11.00
Change From Baseline in SBP and DBP Values at Pre-dialysis and Post-dialysis DBP; post-dialysis; Day 15; n= 17, 20, 18, 22, 21	2.4 mmHg Standard Deviation 11.41	2.4 mmHg Standard Deviation 7.71	-2.9 mmHg Standard Deviation 11.11	3.6 mmHg Standard Deviation 9.84	-0.8 mmHg Standard Deviation 14.13
Change From Baseline in SBP and DBP Values at Pre-dialysis and Post-dialysis DBP; post-dialysis; Day 29; n= 17, 19, 18, 19, 17	3.7 mmHg Standard Deviation 12.93	-2.5 mmHg Standard Deviation 8.52	-3.2 mmHg Standard Deviation 11.61	4.1 mmHg Standard Deviation 9.33	0.2 mmHg Standard Deviation 10.59
Change From Baseline in SBP and DBP Values at Pre-dialysis and Post-dialysis DBP; post-dialysis; Day 43; n= 16, 20, 19, 21, 21	-0.6 mmHg Standard Deviation 10.07	-0.3 mmHg Standard Deviation 9.53	-3.8 mmHg Standard Deviation 12.13	4.5 mmHg Standard Deviation 9.99	4.8 mmHg Standard Deviation 10.28

SECONDARY outcome

Timeframe: Up to Day 43

Population: Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Vital sign measurements including pulse rate were taken in a seated or semi-supine position in the dialysis chair. Pulse rate was measured pre-dialysis and post-dialysis. Pre-dialysis Baseline value was defined as pulse rate value obtained pre-dialysis on Day 1. Post-dialysis Baseline value was defined as pulse rate value obtained post-dialysis at Week -2. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Change From Baseline in Pulse Rate Value at Pre-dialysis and Post-dialysis Pre-dialysis; Day 15; n= 17, 20, 18, 22, 21	7.0 Beats per minute Standard Deviation 9.50	-2.6 Beats per minute Standard Deviation 8.46	2.3 Beats per minute Standard Deviation 5.76	0.7 Beats per minute Standard Deviation 11.46	-1.4 Beats per minute Standard Deviation 11.15
Change From Baseline in Pulse Rate Value at Pre-dialysis and Post-dialysis Pre-dialysis; Day 29; n= 17, 19, 18, 19, 17	2.4 Beats per minute Standard Deviation 6.92	0.9 Beats per minute Standard Deviation 12.86	3.4 Beats per minute Standard Deviation 7.58	0.5 Beats per minute Standard Deviation 10.01	-3.0 Beats per minute Standard Deviation 9.14
Change From Baseline in Pulse Rate Value at Pre-dialysis and Post-dialysis Pre-dialysis; Day 43; n= 16, 20, 19, 21, 21	3.1 Beats per minute Standard Deviation 9.59	0.1 Beats per minute Standard Deviation 6.57	0.8 Beats per minute Standard Deviation 6.11	-0.6 Beats per minute Standard Deviation 10.03	0.2 Beats per minute Standard Deviation 6.79
Change From Baseline in Pulse Rate Value at Pre-dialysis and Post-dialysis Post-dialysis; Day 15; n= 17, 20, 18, 22, 21	2.2 Beats per minute Standard Deviation 11.61	-1.2 Beats per minute Standard Deviation 12.86	1.1 Beats per minute Standard Deviation 10.15	0.5 Beats per minute Standard Deviation 8.00	4.4 Beats per minute Standard Deviation 13.28
Change From Baseline in Pulse Rate Value at Pre-dialysis and Post-dialysis Post-dialysis; Day 29; n= 17, 19, 18, 19, 17	4.2 Beats per minute Standard Deviation 9.13	1.5 Beats per minute Standard Deviation 13.13	-0.8 Beats per minute Standard Deviation 9.79	2.6 Beats per minute Standard Deviation 9.04	6.0 Beats per minute Standard Deviation 7.50
Change From Baseline in Pulse Rate Value at Pre-dialysis and Post-dialysis Post-dialysis; Day 43; n= 16, 20, 19, 21, 21	2.3 Beats per minute Standard Deviation 8.67	0.3 Beats per minute Standard Deviation 12.96	-0.8 Beats per minute Standard Deviation 9.32	-0.1 Beats per minute Standard Deviation 9.08	3.9 Beats per minute Standard Deviation 9.32

SECONDARY outcome

Timeframe: Up to Day 43

Population: Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Vital sign measurements including weight were taken in a seated or semi-supine position in the dialysis chair. Weight was measured post-dialysis. Post-dialysis Baseline value was defined as SBP and DBP value obtained post-dialysis at Week -2. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 Participants Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 Participants Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 Participants Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 Participants Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Change From Baseline in Weight at Post-dialysis Day 15; n= 17, 20, 18, 22, 21	-0.16 kg Standard Deviation 0.634	0.16 kg Standard Deviation 0.971	-0.01 kg Standard Deviation 0.617	0.06 kg Standard Deviation 0.799	-0.31 kg Standard Deviation 1.215
Change From Baseline in Weight at Post-dialysis Day 29; n= 17, 19, 18, 19, 17	-0.11 kg Standard Deviation 1.053	-0.05 kg Standard Deviation 1.583	-1.23 kg Standard Deviation 5.913	-0.16 kg Standard Deviation 1.046	-0.19 kg Standard Deviation 1.244
Change From Baseline in Weight at Post-dialysis Day 43; n= 16, 20, 19, 21, 21	-0.21 kg Standard Deviation 0.665	0.37 kg Standard Deviation 2.760	-1.39 kg Standard Deviation 5.759	0.15 kg Standard Deviation 1.472	0.33 kg Standard Deviation 2.169

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Dapro 10 mg

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Dapro 15 mg

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Dapro 25 mg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Dapro 30 mg

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=19 participants at risk Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 participants at risk Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 participants at risk Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 participants at risk Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 participants at risk Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Metabolism and nutrition disorders Fluid overload	0.00% 0/19 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	4.5% 1/22 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	4.5% 1/22 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
Cardiac disorders Angina unstable	0.00% 0/19 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	5.0% 1/20 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	4.5% 1/22 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
Cardiac disorders Cardiac failure congestive	0.00% 0/19 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	10.0% 2/20 • Number of events 2 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
Gastrointestinal disorders Mesenteric artery stenosis	0.00% 0/19 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	5.0% 1/20 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	5.3% 1/19 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
Injury, poisoning and procedural complications Post procedural myocardial infarction	0.00% 0/19 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	5.0% 1/20 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
Vascular disorders Hypertensive crisis	0.00% 0/19 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	5.0% 1/20 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
Vascular disorders Orthostatic hypotension	5.3% 1/19 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Other adverse events

Other adverse events
Measure	Placebo n=19 participants at risk Randomized participants received placebo tablet via oral route three times weekly for 29 days.	Dapro 10 mg n=20 participants at risk Randomized participants received dapro 10 mg tablet via oral route three times weekly for 29 days.	Dapro 15 mg n=20 participants at risk Randomized participants received dapro 15 mg tablet via oral route three times weekly for 29 days.	Dapro 25 mg n=22 participants at risk Randomized participants received dapro 25 mg tablet via oral route three times weekly for 29 days.	Dapro 30 mg n=22 participants at risk Randomized participants received dapro 30 mg tablet via oral route three times weekly for 29 days
Cardiac disorders Bundle branch block left	0.00% 0/19 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	5.0% 1/20 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
Endocrine disorders Hyperparathyroidism	0.00% 0/19 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	5.0% 1/20 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
Gastrointestinal disorders Diarrhoea	0.00% 0/19 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	10.0% 2/20 • Number of events 2 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
Gastrointestinal disorders Dyspepsia	0.00% 0/19 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	5.0% 1/20 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/19 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	5.0% 1/20 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
Gastrointestinal disorders Vomiting	0.00% 0/19 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	5.0% 1/20 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
General disorders Asthenia	5.3% 1/19 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	5.0% 1/20 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
General disorders Pyrexia	0.00% 0/19 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	5.0% 1/20 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
Infections and infestations Helicobacter gastritis	5.3% 1/19 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
Infections and infestations Pneumonia	0.00% 0/19 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	5.0% 1/20 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
Infections and infestations Upper respiratory tract infection	0.00% 0/19 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	5.0% 1/20 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
Infections and infestations Viral infection	0.00% 0/19 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	5.0% 1/20 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
Injury, poisoning and procedural complications Arteriovenous fistula site haemorrhage	0.00% 0/19 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	5.0% 1/20 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
Injury, poisoning and procedural complications Procedural hypotension	0.00% 0/19 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	5.0% 1/20 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	4.5% 1/22 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
Metabolism and nutrition disorders Dehydration	5.3% 1/19 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/19 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	5.0% 1/20 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/19 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	5.0% 1/20 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.3% 1/19 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
Nervous system disorders Dizziness	5.3% 1/19 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	5.0% 1/20 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
Nervous system disorders Headache	5.3% 1/19 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
Psychiatric disorders Depression	0.00% 0/19 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	5.0% 1/20 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
Respiratory, thoracic and mediastinal disorders Catarrh	0.00% 0/19 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	5.0% 1/20 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/20 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.
Vascular disorders Hypotension	0.00% 0/19 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	5.0% 1/20 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	5.0% 1/20 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	4.5% 1/22 • Number of events 1 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.	0.00% 0/22 • On-therapy serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the start of study treatment to the end of the 29-day study treatment period plus 1 day, inclusive; an average of 30 days. On-therapy SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who received at least one dose of investigational drug. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER