| Primary | Maximum Change From Baseline in Hb During Weeks 3-13 | 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. | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. | Posted | | Mean | Standard Error | grams/deciliter (g/dL) | | Baseline, Weeks 3-13 | | | | ID | Title | Description |
|---|
| OG000 | 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 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | | OG001 | 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. | | OG002 | 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. | | OG003 | 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. |
| | Units | Counts |
|---|
| Participants | - OG00023
- OG00112
- OG00210
- OG003
|
| | Title | Denominators | Categories |
|---|
| Baseline | | | Title | Measurements |
|---|
| - OG0008.1± 0.2
- OG0018.5± 0.3
- OG0028.4± 0.3
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Analysis of covariance (ANCOVA) model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments. | ANCOVA | | 0.0757 | Threshold for significance at 0.05 level. | | | | | | | | | | | | | Other | | | | |
|
| Secondary | Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. | 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. | Posted | | Mean | Standard Error | g/dL | | Baseline, Weeks 2-5, 6-9, and 10-13 | | | | ID | Title | Description |
|---|
| OG000 | 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 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | | OG001 | 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. | | OG002 | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg |
|
| Secondary | 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 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. | 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. | Posted | | Count of Participants | | Participants | | Week 3 to 13 | | | | ID | Title | Description |
|---|
| OG000 | 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 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | | OG001 | 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. | | OG002 | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg |
|
| Secondary | 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 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. | 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. | Posted | | Count of Participants | | Participants | | Week 3 to 13 | | | | ID | Title | Description |
|---|
| OG000 | 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 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | | OG001 | 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. | | OG002 | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg |
|
| Secondary | 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 | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. | 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. | Posted | | Count of Participants | | Participants | | Weeks 5, 9, and 13 | | | | ID | Title | Description |
|---|
| OG000 | 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 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | | OG001 | 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. | | OG002 | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg |
|
| Secondary | Number of Participants Who Achieved Maximum Hb During Weeks 3-13 | | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. | Posted | | Count of Participants | | Participants | | Weeks 3-13 | | | | ID | Title | Description |
|---|
| OG000 | 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 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 | 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. | EE population included participants who received study treatment for 6 weeks or longer and had valid corresponding Hb measurements. | Posted | | Count of Participants | | Participants | | Baseline, Weeks 3-13 | | | | ID | Title | Description |
|---|
| OG000 | 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 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | | OG001 | 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. | |
|
| Secondary | Median Time to Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline) | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. | 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. | Posted | | Median | 95% Confidence Interval | weeks | | Baseline up to Week 13 | | | | ID | Title | Description |
|---|
| OG000 | 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 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | | OG001 | 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. | | OG002 | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg |
|
| Secondary | Weekly Dose at First Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline) | Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. | 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. | Posted | | Mean | Standard Deviation | mg/kg | | Baseline up to Week 13 | | | | ID | Title | Description |
|---|
| OG000 | 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 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | | OG001 | 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. | | OG002 |
|
| Secondary | Number of Participants Requiring Dose Increase at Weeks 5 and 9 | Number of participants requiring dose increase due to any reasons is reported. | Safety population included all participants who received any dose of study drug. | Posted | | Count of Participants | | Participants | | Weeks 5 and 9 | | | | ID | Title | Description |
|---|
| OG000 | 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 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis | Number of participants requiring dose reduction or dose discontinuation due to excessive erythropoiesis is reported. | Safety population included all participants who received any dose of study drug. | Posted | | Count of Participants | | Participants | | Weeks 5 and 9 | | | | ID | Title | Description |
|---|
| OG000 | 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 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | | OG001 | 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. | | OG002 | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | |
|
| Secondary | Change From Baseline in Ferritin at Week 13 | Baseline was defined as the average of the last 2 values prior to the first dose administration. | 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. | Posted | | Mean | Standard Error | micrograms/liter (µg/L) | | Baseline, Week 13 | | | | ID | Title | Description |
|---|
| OG000 | 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 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | | OG001 | 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. | | OG002 | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg |
|
| Secondary | Change From Baseline in Transferrin Saturation (TSAT) at Week 13 | | 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. | Posted | | Mean | Standard Error | percentage of transferrin | | Baseline, Week 13 | | | | ID | Title | Description |
|---|
| OG000 | 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 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Change From Baseline in Reticulocyte Hemoglobin Content at Week 13 | | 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. | Posted | | Mean | Standard Error | picogram (pg) | | Baseline, Week 13 | | | | ID | Title | Description |
|---|
| OG000 | 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 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | | OG001 | 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. | | OG002 | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | |
|
| Secondary | Number of Participants With Mean Hb Values 11.0-13.0 g/dL at Weeks 6-9 and 10-13 | | 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. | Posted | | Count of Participants | | Participants | | Weeks 6-9 and 10-13 | | | | ID | Title | Description |
|---|
| OG000 | 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 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | 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 | | 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. | Posted | | Count of Participants | | Participants | | Weeks 10-13 | | | | ID | Title | Description |
|---|
| OG000 | 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 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | | OG001 | 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. | | OG002 | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg |
|
| Secondary | 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 | | 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. | Posted | | Count of Participants | | Participants | | Weeks 10-13 | | | | ID | Title | Description |
|---|
| OG000 | 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 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | | OG001 | 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. | | OG002 | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg |
|
| Secondary | Number of Participants With Mean Hb Values in Excess of 13.0 and 14.0 g/dL at Weeks 6-9 and 10-13 | | 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. | Posted | | Count of Participants | | Participants | | Weeks 6-9 and 10-13 | | | | ID | Title | Description |
|---|
| OG000 | 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 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Number of Participants With Mean Hb Values <10.0 g/dL at Weeks 6-9 and 10-13 | | 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. | Posted | | Count of Participants | | Participants | | Weeks 6-9 and 10-13 | | | | ID | Title | Description |
|---|
| OG000 | 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 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C) | Number of participants requiring rescue treatment with an ESA, RBC transfusion, or IV Iron (Excluding Arm C) was reported. | Safety population included all participants who received any dose of study drug. Here 'Number analyzed' signifies participants evaluable for specified category. | Posted | | Count of Participants | | Participants | | Baseline up to Week 13 | | | | ID | Title | Description |
|---|
| OG000 | 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 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | | OG001 | 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. | | OG002 | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg |
|
| Secondary | Number of Participants Requiring Therapeutic Phlebotomy | Number of participants who required therapeutic phlebotomy due to TEAE of abnormal erythropoiesis is reported. | Safety population included all participants who received any dose of study drug. | Posted | | Count of Participants | | Participants | | Baseline up to Week 13 | | | | ID | Title | Description |
|---|
| OG000 | 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 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | | OG001 | 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. | | OG002 | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | |
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| Secondary | Number of Participants Withdrawn From the Study Due to Inadequate Efficacy | Number of participants withdrawn from the study due to inadequate efficacy is reported. | Safety population included all participants who received any dose of study drug. | Posted | | Count of Participants | | Participants | | Baseline up to Week 16 | | | | ID | Title | Description |
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| OG000 | 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 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | | OG001 | 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. | | OG002 | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | |
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| Secondary | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 | 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. | 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. | Posted | | Mean | Standard Error | units on a scale | | Baseline, Weeks 9 and 13 | | | | ID | Title | Description |
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| OG000 | 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 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | | OG001 | 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. |
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| Secondary | Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score at Weeks 9 and 13 | 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. | 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. | Posted | | Mean | Standard Error | units on a scale | | Baseline, Weeks 9 and 13 | | | | ID | Title | Description |
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| OG000 | 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 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | | OG001 | Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | |
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| Secondary | Number of Participants With Potentially Clinically Significant Laboratory Tests | 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. | Safety population included all participants who received any dose of study drug. | Posted | | Count of Participants | | Participants | | Baseline up to Week 16 | | | | ID | Title | Description |
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| OG000 | 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 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | | OG001 | 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. | | OG002 | Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg |
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| Secondary | Number of Participants With TEAEs | 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. | Safety population included all participants who received any dose of study drug. | Posted | | Count of Participants | | Participants | | Baseline up to Week 16 | | | | ID | Title | Description |
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| OG000 | 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 mg) based on weight and Hb level, administered orally TIW for 12 weeks. | | OG001 | 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. | |
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