Trial Outcomes & Findings for Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment (NCT NCT01414075)

NCT ID: NCT01414075

Last Updated: 2021-10-01

Results Overview

Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. This outcome measure is derived from the maximum change from baseline during Weeks 3-13, without last observation carried forward (LOCF) imputation.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 60 participants
• Primary outcome timeframe: Baseline, Weeks 3-13
• Results posted on: 2021-10-01

Participant Flow

Participants on hemodialysis (HD) were randomized to one of the 3 arms A, B, or C in 1:1:1 ratio to receive roxadustat with either no, per oral (PO), or intravenous (IV) iron supplementation, respectively. Participants on peritoneal dialysis (PD) were enrolled into Arm D and received roxadustat with PO iron supplementation.

Arm E was an optional, confirmatory/supplemental arm with flexible dosing and flexible iron supplementation based on the evaluation of data from the previous 4 arms. After enrollment of Arms A through C was completed, Arm E was decided to be identical to Arm A, for example, roxadustat with no iron supplementation and with the same tiered weight-based initial dosing. Hence, the data of Arms A and E were reported in a single arm.

Participant milestones

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 milligrams \[mg\]) based on weight and hemoglobin (Hb) level, administered orally 3 times weekly (TIW) for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Overall Study STARTED	24	12	12	12
Overall Study Efficacy Evaluable (EE) Population	23	12	10	10
Overall Study COMPLETED	21	12	10	10
Overall Study NOT COMPLETED	3	0	2	2

Reasons for withdrawal

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 milligrams \[mg\]) based on weight and hemoglobin (Hb) level, administered orally 3 times weekly (TIW) for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Overall Study Adverse Event	1	0	1	0
Overall Study Death	1	0	0	1
Overall Study Withdrawal by Subject	0	0	0	1
Overall Study Other than specified	1	0	1	0

Baseline Characteristics

Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment

Baseline characteristics by cohort

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=24 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Total n=60 Participants Total of all reporting groups
Age, Continuous	49.6 years STANDARD_DEVIATION 17.7 • n=5 Participants	46.8 years STANDARD_DEVIATION 14.6 • n=7 Participants	53.1 years STANDARD_DEVIATION 12.6 • n=5 Participants	51.4 years STANDARD_DEVIATION 12.4 • n=4 Participants	50.1 years STANDARD_DEVIATION 15.0 • n=21 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	10 Participants n=4 Participants	29 Participants n=21 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	31 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Weeks 3-13

Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements.

Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. This outcome measure is derived from the maximum change from baseline during Weeks 3-13, without last observation carried forward (LOCF) imputation.

Outcome measures

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=23 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=10 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=10 Participants Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Maximum Change From Baseline in Hb During Weeks 3-13 Change at Weeks 3-13	2.8 grams/deciliter (g/dL) Standard Error 0.2	3.5 grams/deciliter (g/dL) Standard Error 0.5	3.5 grams/deciliter (g/dL) Standard Error 0.4	3.3 grams/deciliter (g/dL) Standard Error 0.2
Maximum Change From Baseline in Hb During Weeks 3-13 Baseline	8.1 grams/deciliter (g/dL) Standard Error 0.2	8.5 grams/deciliter (g/dL) Standard Error 0.3	8.4 grams/deciliter (g/dL) Standard Error 0.3	8.7 grams/deciliter (g/dL) Standard Error 0.2

SECONDARY outcome

Timeframe: Baseline, Weeks 2-5, 6-9, and 10-13

Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values.

Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.

Outcome measures

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=23 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=10 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=10 Participants Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 Baseline	8.1 g/dL Standard Error 0.2	8.5 g/dL Standard Error 0.3	8.4 g/dL Standard Error 0.3	8.7 g/dL Standard Error 0.2
Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 Change at Weeks 2-5	1.1 g/dL Standard Error 0.1	1.1 g/dL Standard Error 0.2	1.0 g/dL Standard Error 0.2	0.8 g/dL Standard Error 0.3
Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 Change at Weeks 6-9	2.0 g/dL Standard Error 0.2	2.3 g/dL Standard Error 0.4	2.0 g/dL Standard Error 0.4	1.8 g/dL Standard Error 0.4
Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 Change at Weeks 10-13	2.1 g/dL Standard Error 0.2	2.7 g/dL Standard Error 0.5	3.0 g/dL Standard Error 0.4	2.4 g/dL Standard Error 0.2

SECONDARY outcome

Timeframe: Week 3 to 13

Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values.

Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.

Outcome measures

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=23 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=10 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=10 Participants Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥11.0 g/dL	10 Participants	8 Participants	8 Participants	9 Participants

SECONDARY outcome

Timeframe: Week 3 to 13

Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values.

Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.

Outcome measures

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=23 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=10 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=10 Participants Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥10.0 g/dL	17 Participants	10 Participants	8 Participants	10 Participants

SECONDARY outcome

Timeframe: Weeks 5, 9, and 13

Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values.

Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.

Outcome measures

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=23 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=10 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=10 Participants Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13 Week 5	21 Participants	9 Participants	7 Participants	7 Participants
Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13 Week 9	22 Participants	10 Participants	9 Participants	9 Participants
Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13 Week 13	22 Participants	11 Participants	10 Participants	10 Participants

SECONDARY outcome

Timeframe: Weeks 3-13

Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements.

Outcome measures

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=23 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=10 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=10 Participants Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Number of Participants Who Achieved Maximum Hb During Weeks 3-13 <10 g/dL	6 Participants	1 Participants	2 Participants	0 Participants
Number of Participants Who Achieved Maximum Hb During Weeks 3-13 10 to <11 g/dL	7 Participants	3 Participants	0 Participants	1 Participants
Number of Participants Who Achieved Maximum Hb During Weeks 3-13 11 to 13 g/dL	10 Participants	5 Participants	5 Participants	9 Participants
Number of Participants Who Achieved Maximum Hb During Weeks 3-13 >13 to 14 g/dL	0 Participants	1 Participants	3 Participants	0 Participants
Number of Participants Who Achieved Maximum Hb During Weeks 3-13 >14 g/dL	0 Participants	2 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 3-13

Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements.

Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. The number of participants who fall within the following categories of maximum change are reported: <1 g/dL, ≥1 g/dL, 1 to <2 g/dL, 2 to <3 g/dL, >3 to <4 g/dL, ≥4 g/dL.

Outcome measures

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=23 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=10 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=10 Participants Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 ≥1 g/dL	22 Participants	11 Participants	10 Participants	10 Participants
Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 1 to <2 g/dL	4 Participants	2 Participants	2 Participants	0 Participants
Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 2 to <3 g/dL	9 Participants	2 Participants	0 Participants	5 Participants
Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 >3 to <4 g/dL	7 Participants	2 Participants	4 Participants	3 Participants
Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 ≥4 g/dL	2 Participants	5 Participants	4 Participants	2 Participants
Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 <1 g/dL	1 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 13

Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values.

Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.

Outcome measures

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=23 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=10 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=10 Participants Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Median Time to Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline)	4.0 weeks Interval 3.0 to 4.0	4.0 weeks Interval 3.0 to 6.0	4.0 weeks Interval 3.0 to 6.0	4.0 weeks Interval 3.0 to 8.0

SECONDARY outcome

Timeframe: Baseline up to Week 13

Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. LOCF method was used to impute missing values.

Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration.

Outcome measures

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=22 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=11 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=10 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=10 Participants Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Weekly Dose at First Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline)	4.2 mg/kg Standard Deviation 0.5	4.2 mg/kg Standard Deviation 1.2	4.5 mg/kg Standard Deviation 1.4	4.3 mg/kg Standard Deviation 1.4

SECONDARY outcome

Timeframe: Weeks 5 and 9

Population: Safety population included all participants who received any dose of study drug.

Number of participants requiring dose increase due to any reasons is reported.

Outcome measures

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=24 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Number of Participants Requiring Dose Increase at Weeks 5 and 9 Week 5	2 Participants	3 Participants	2 Participants	4 Participants
Number of Participants Requiring Dose Increase at Weeks 5 and 9 Week 9	8 Participants	5 Participants	3 Participants	5 Participants

SECONDARY outcome

Timeframe: Weeks 5 and 9

Population: Safety population included all participants who received any dose of study drug.

Number of participants requiring dose reduction or dose discontinuation due to excessive erythropoiesis is reported.

Outcome measures

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=24 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis Dose reduced at Week 5	3 Participants	5 Participants	3 Participants	5 Participants
Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis Dose interrupted at Week 5	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis Dose reduced at Week 9	1 Participants	0 Participants	3 Participants	0 Participants
Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis Dose interrupted at Week 9	1 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Week 13

Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values.

Baseline was defined as the average of the last 2 values prior to the first dose administration.

Outcome measures

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=23 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=10 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=10 Participants Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Change From Baseline in Ferritin at Week 13 Baseline	156.4 micrograms/liter (µg/L) Standard Error 12.9	162.5 micrograms/liter (µg/L) Standard Error 30.8	182.0 micrograms/liter (µg/L) Standard Error 27.4	137.4 micrograms/liter (µg/L) Standard Error 27.0
Change From Baseline in Ferritin at Week 13 Change at Week 13	-119.7 micrograms/liter (µg/L) Standard Error 12.2	-51.1 micrograms/liter (µg/L) Standard Error 25.2	-25.2 micrograms/liter (µg/L) Standard Error 33.5	-65.1 micrograms/liter (µg/L) Standard Error 29.4

SECONDARY outcome

Timeframe: Baseline, Week 13

Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values.

Outcome measures

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=23 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=10 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=10 Participants Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Change From Baseline in Transferrin Saturation (TSAT) at Week 13 Baseline	18.8 percentage of transferrin Standard Error 0.8	19.0 percentage of transferrin Standard Error 1.0	18.1 percentage of transferrin Standard Error 1.5	19.3 percentage of transferrin Standard Error 1.8
Change From Baseline in Transferrin Saturation (TSAT) at Week 13 Change at Week 13	-7.4 percentage of transferrin Standard Error 1.4	2.6 percentage of transferrin Standard Error 2.5	0.7 percentage of transferrin Standard Error 2.9	-1.6 percentage of transferrin Standard Error 2.6

SECONDARY outcome

Timeframe: Baseline, Week 13

Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. LOCF method was used to impute missing values.

Outcome measures

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=21 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=10 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=10 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=10 Participants Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Change From Baseline in Reticulocyte Hemoglobin Content at Week 13 Baseline	31.0 picogram (pg) Standard Error 0.3	31.6 picogram (pg) Standard Error 0.5	31.5 picogram (pg) Standard Error 0.5	30.4 picogram (pg) Standard Error 0.4
Change From Baseline in Reticulocyte Hemoglobin Content at Week 13 Change at Week 13	-2.2 picogram (pg) Standard Error 0.7	-1.9 picogram (pg) Standard Error 0.9	-1.0 picogram (pg) Standard Error 0.6	-0.2 picogram (pg) Standard Error 0.6

SECONDARY outcome

Timeframe: Weeks 6-9 and 10-13

Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values.

Outcome measures

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=23 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=10 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=10 Participants Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Number of Participants With Mean Hb Values 11.0-13.0 g/dL at Weeks 6-9 and 10-13 Weeks 6-9	6 Participants	5 Participants	4 Participants	5 Participants
Number of Participants With Mean Hb Values 11.0-13.0 g/dL at Weeks 6-9 and 10-13 Weeks 10-13	5 Participants	2 Participants	5 Participants	7 Participants

SECONDARY outcome

Timeframe: Weeks 10-13

Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. Here, 'Overall number of participants analyzed' signifies participants with maximum Hb ≥11 g/dL and change of Hb ≥1 g/dL during Weeks 10-13. LOCF method was used to impute missing values.

Outcome measures

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=10 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=8 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=8 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=9 Participants Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Number of Participants With Mean Hb Values Within 11.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥11.0 g/dL and Change of Hb ≥1 g/dL	5 Participants	2 Participants	5 Participants	7 Participants

SECONDARY outcome

Timeframe: Weeks 10-13

Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. Here, 'Overall number of participants analyzed' signifies participants with maximum Hb ≥10 g/dL and change of Hb ≥1 g/dL during Weeks 10-13. LOCF method was used to impute missing values.

Outcome measures

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=17 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=10 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=8 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=10 Participants Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Number of Participants With Mean Hb Values Within 10.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥10.0 g/dL and Change of Hb ≥1 g/dL	15 Participants	7 Participants	7 Participants	9 Participants

SECONDARY outcome

Timeframe: Weeks 6-9 and 10-13

Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values.

Outcome measures

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=23 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=10 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=10 Participants Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Number of Participants With Mean Hb Values in Excess of 13.0 and 14.0 g/dL at Weeks 6-9 and 10-13 Week 6-9	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Mean Hb Values in Excess of 13.0 and 14.0 g/dL at Weeks 6-9 and 10-13 Week 10-13	0 Participants	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Weeks 6-9 and 10-13

Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values.

Outcome measures

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=23 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=10 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=10 Participants Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Number of Participants With Mean Hb Values <10.0 g/dL at Weeks 6-9 and 10-13 Week 6-9	10 Participants	4 Participants	2 Participants	3 Participants
Number of Participants With Mean Hb Values <10.0 g/dL at Weeks 6-9 and 10-13 Week 10-13	8 Participants	3 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 13

Population: Safety population included all participants who received any dose of study drug. Here 'Number analyzed' signifies participants evaluable for specified category.

Number of participants requiring rescue treatment with an ESA, RBC transfusion, or IV Iron (Excluding Arm C) was reported.

Outcome measures

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=24 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C) Blood transfusion for severe anemia	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C) Blood transfusion for gastrointestinal bleeding	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C) IV iron for acute iron deficiency	1 Participants	0 Participants	—	0 Participants
Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C) IV iron for a treatment-emergent adverse event (TEAE) of thrombocytosis	1 Participants	0 Participants	—	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 13

Population: Safety population included all participants who received any dose of study drug.

Number of participants who required therapeutic phlebotomy due to TEAE of abnormal erythropoiesis is reported.

Outcome measures

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=24 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Number of Participants Requiring Therapeutic Phlebotomy	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: Safety population included all participants who received any dose of study drug.

Number of participants withdrawn from the study due to inadequate efficacy is reported.

Outcome measures

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=24 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Number of Participants Withdrawn From the Study Due to Inadequate Efficacy	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 9 and 13

Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values.

The SF-36 V2 consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The physical functioning subscore and vitality subscore are reported. The scores ranged from 0 (worst) to 100 (Best). Higher score indicated a better health state. Baseline is defined as the last non-missing value prior to the first dose administration.

Outcome measures

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=23 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=10 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=10 Participants Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 Physical functioning subscore: Baseline	38.8 units on a scale Standard Error 2.3	40.7 units on a scale Standard Error 3.2	41.2 units on a scale Standard Error 3.4	40.8 units on a scale Standard Error 1.8
Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 Physical functioning subscore: Change at Week 9	4.8 units on a scale Standard Error 1.6	1.6 units on a scale Standard Error 2.5	1.5 units on a scale Standard Error 2.5	3.4 units on a scale Standard Error 1.2
Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 Physical functioning subscore: Change at Week 13	5.2 units on a scale Standard Error 1.8	1.8 units on a scale Standard Error 2.1	4.8 units on a scale Standard Error 1.8	2.3 units on a scale Standard Error 1.3
Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 Vitality subscore: Baseline	46.3 units on a scale Standard Error 2.2	48.2 units on a scale Standard Error 4.1	49.0 units on a scale Standard Error 3.5	46.8 units on a scale Standard Error 3.6
Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 Vitality subscore: Change at Week 9	2.9 units on a scale Standard Error 1.8	-1.0 units on a scale Standard Error 4.0	3.4 units on a scale Standard Error 2.8	5.9 units on a scale Standard Error 3.0
Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 Vitality subscore: Change at Week 13	3.9 units on a scale Standard Error 1.7	1.6 units on a scale Standard Error 3.7	3.1 units on a scale Standard Error 2.3	6.2 units on a scale Standard Error 1.6

SECONDARY outcome

Timeframe: Baseline, Weeks 9 and 13

Population: EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. LOCF method was used to impute missing values.

FACT-An is composed of 27 core items which assess participant's function in 4 domains and 20 anemia-related items, grouped into 5 subscales as follows: Physical well-being (PWB): 7 items; Social/family well-being (SWB): 7 items; Emotional well-being (EWB): 6 items; Functional well-being (FWB): 7 items; and Anemia: 20 items. All FACT-An items were rated as: 0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much. Each subscale score was the sum of scores for the items in the subscale. The FACT-An total score was the sum of all 5 subscale scores, ranging from 0 (worst) - 188 (best). Higher scores represented better quality of life. Baseline is defined as the last non-missing value prior to the first dose administration.

Outcome measures

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=23 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=10 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=10 Participants Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score at Weeks 9 and 13 Baseline	123.5 units on a scale Standard Error 6.8	118.9 units on a scale Standard Error 10.9	128.8 units on a scale Standard Error 11.3	122.8 units on a scale Standard Error 7.9
Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score at Weeks 9 and 13 Change at Week 9	8.2 units on a scale Standard Error 4.5	4.0 units on a scale Standard Error 7.2	1.9 units on a scale Standard Error 9.8	12.8 units on a scale Standard Error 6.9
Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score at Weeks 9 and 13 Change at Week 13	7.3 units on a scale Standard Error 4.3	5.9 units on a scale Standard Error 6.9	5.1 units on a scale Standard Error 8.9	12.9 units on a scale Standard Error 7.4

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: Safety population included all participants who received any dose of study drug.

Criteria for the potential clinical significance included: bilirubin (µmol/L) >1.5 * upper limit of normal (ULN), potassium (mmol/L) >1.2 * ULN, neutrophils (*10^9/L) ≤1, protein (g/L) >1.1 * ULN, leukocytes (*10^9/L) ≤2.5 or ≥15.

Outcome measures

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=24 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Number of Participants With Potentially Clinically Significant Laboratory Tests Bilirubin	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Potentially Clinically Significant Laboratory Tests Potassium	2 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Potentially Clinically Significant Laboratory Tests Neutrophils	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Potentially Clinically Significant Laboratory Tests Protein	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Potentially Clinically Significant Laboratory Tests Leukocytes	1 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 16

Population: Safety population included all participants who received any dose of study drug.

An adverse event (AE) was any untoward medical event in a participant who received study drug whether or not the event is considered drug related. TEAEs were defined as any event that either began or worsened after the first administration of study drug and within 28 days of the last dose. A summary of other nonserious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Outcome measures

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=24 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=12 Participants Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 Participants Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Number of Participants With TEAEs	16 Participants	6 Participants	3 Participants	5 Participants

Adverse Events

Arm A + E (Participants on HD): Roxadustat Only, No Iron

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg

Serious events: 3 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=24 participants at risk Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 participants at risk Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=12 participants at risk Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 participants at risk Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Cardiac disorders Cardiac failure acute	0.00% 0/24 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	0.00% 0/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	0.00% 0/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	8.3% 1/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".
Cardiac disorders Cardiac failure chronic	4.2% 1/24 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	0.00% 0/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	0.00% 0/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	0.00% 0/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".
Cardiac disorders Myocardial infarction	4.2% 1/24 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	0.00% 0/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	0.00% 0/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	0.00% 0/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".
Gastrointestinal disorders Gastrointestinal haemorrhage	4.2% 1/24 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	0.00% 0/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	0.00% 0/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	0.00% 0/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".
Infections and infestations Device related infection	0.00% 0/24 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	8.3% 1/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	0.00% 0/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	0.00% 0/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".
Infections and infestations Pyelonephritis chronic	4.2% 1/24 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	0.00% 0/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	0.00% 0/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	0.00% 0/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	4.2% 1/24 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	8.3% 1/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	0.00% 0/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	0.00% 0/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".
Injury, poisoning and procedural complications Chemical peritonitis	0.00% 0/24 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	0.00% 0/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	0.00% 0/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	16.7% 2/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".

Other adverse events

Measure	Arm A + E (Participants on HD): Roxadustat Only, No Iron n=24 participants at risk Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.	Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 participants at risk Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron PO (ferrous fumarate or ferrous gluconate) at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.	Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg n=12 participants at risk Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.	Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg n=12 participants at risk Participants on PD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.
Investigations Transferrin saturation decreased	12.5% 3/24 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	8.3% 1/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	0.00% 0/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	0.00% 0/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".
Vascular disorders Hypertension	4.2% 1/24 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	25.0% 3/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	0.00% 0/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	16.7% 2/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".
Vascular disorders Phlebitis	8.3% 2/24 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	8.3% 1/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	0.00% 0/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".	0.00% 0/12 • Baseline up to Week 16 Safety population included all participants who received any dose of study drug. Non-serious adverse events are reported in the section labeled "Other Adverse Events".

Additional Information

Clinical Trial Information Desk

FibroGen, Inc.

Phone: 415-978-1441

Results disclosure agreements

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