Anemia, Chronic Kidney Disease
Conditions
Keywords
Kidney, Chronic Kidney Disease, CKD, Renal, Anemia, Oral anemia treatment, Hemoglobin levels, Erythropoietin, Blood count, Predialysis, Pre-dialysis, Hb, Non-dialysis
Brief summary
The primary purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with non-dialysis chronic kidney disease.
Interventions
DRUGRoxadustat
Oral capsule
Sponsors
Astellas Pharma Inc
Kyntra Bio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 to 75 years 2. Chronic kidney disease, not receiving dialysis 3. Body weight 45 to 140 kg
Exclusion criteria
1. Any clinically significant infection or evidence of an underlying infection 2. Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab) 3. History of chronic liver disease 4. New York Heart Association Class III or IV congestive heart failure 5. Myocardial infarction or acute coronary syndrome within 12 weeks prior to randomization 6. History of malignancy 7. Chronic inflammatory disease that could impact erythropoiesis (for example, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission 8. History of myelodysplastic syndrome, multiple myeloma, or pure red cell aplasia 9. History of hemosiderosis, hemochromatosis or polycystic kidney disease 10. Active hemolysis or diagnosis of hemolytic syndrome 11. Uncontrolled or symptomatic secondary hyperparathyroidism 12. Seizure disorder or receiving anti-epilepsy medication 13. Known bone marrow fibrosis 14. Any prior or scheduled organ transplant 15. Prior treatment with roxadustat or any hypoxia-inducible factor prolyl hydroxylase inhibitor 16. History of alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number (%) of Participants With an Hb Response by Week 17 | Up to Week 17 | An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Baseline, Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only) | Baseline is defined as the mean of the last 3 available values predose. |
| Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only) | Participants can have a Hb value reported for more than 1 of the categories (11-12, 11-13, and 10.5-13 g/dL) during the week intervals since these categories are not mutually exclusive. |
| Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only) | — |
| Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only) | Participants can have a Hb value for the same category (11-12, 11-13, or 10.5-13 g/dL) reported for multiple weeks. |
| Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only) | — |
| Median Time to Hb Response: Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL | Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F) | Median time to response was estimated using Kaplan Meier method, Cohort A and B censored at Week 17, Cohort C, D, E, and F censored at Week 25. The median number of days presented was calculated from Baseline to the day the Hb response was achieved. |
| Median Initial Hb Responsive Time: Time to Initial Hb Increase ≥1.0 g/dL From Baseline | Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C, D, E, and F) | Median time to response was estimated using Kaplan Meier method; Cohort A and B censored at Week 17 and Cohort C, D, E, and F censored at Week 25. The median number of days presented was calculated from Baseline to the day the Hb response was achieved. |
| Median Initial Hb Responsive Dose: Dose at Which Initial Hb Increases to ≥1.0 g/dL From Baseline | Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F) | — |
| Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Cohorts A and B: Weekly through Week 16 (end of treatment), Week 18 (2 weeks posttreatment), and Week 20 (4 weeks posttreatment); Cohorts C-F: Weekly through Week 24 (end of treatment), Week 26 (2 weeks posttreatment), and Week 28 (4 weeks posttreatment) | — |
| Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Up to Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only) | An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL. |
| Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 13-17 (all cohorts) and 18-25 (24-week treatment cohorts only) | The mean percentage of the scheduled weekly Hb values that were \<10.5, \>13, and \>14 g/dL during Weeks 13-17 and 18-25 is presented. |
| Number (%) of Participants Requiring Rescue Therapy | Baseline up to Week 28 (end of study) | Rescue treatment included recombinant erythropoiesis-stimulating agent (ESA), red blood cell transfusion (in the absence of a known bleeding episode or surgical blood loss), or intravenous (IV) Iron |
| Number (%) of Participants Requiring Therapeutic Phlebotomy | Baseline up to Week 28 (end of study) | — |
| Number (%) of Participants Withdrawn From the Study Due to Inadequate Efficacy | Baseline up to Week 28 (end of study) | — |
| Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Weeks 1-4, 5-12, and 13-16 (all cohorts) and Weeks 17-24 (24-week treatment cohorts only) | Dose changes include dose reductions, dose increases, and dose holds. |
| Weekly Total Dose and Cumulative Total Dose (mg/kg) When First Achieving Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | Cohorts A and B: Weekly through Week 16 (end of treatment); Cohorts C-F: Weekly through Week 24 (end of treatment) | — |
| Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | Cohorts A and B: Weekly through Week 16 (end of treatment); Cohorts C-F: Weekly through Week 24 (end of treatment) | — |
| Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24 | Baseline, Weeks 16 (Cohorts A and B End of Treatment) and Week 24 (Cohorts C-F End of Treatment) | Baseline was defined as the mean of the last 3 available values predose. |
| Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | Cohorts A and B: Weekly through Week 16 (end of treatment [EoT]) and Week 20 (Follow up [4 weeks posttreatment]); Cohorts C-F: Weekly through Week 24 (EoT) and Week 28 (Follow up [4 weeks posttreatment]) | — |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW Participants received roxadustat capsules, administered orally TIW for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. | 24 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW Participants received roxadustat capsules orally for 16 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 60, 100, and 140 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. | 24 |
| Cohort C: Roxadustat at 50 mg TIW Participants received roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | 24 |
| Cohort D: Roxadustat at 100 mg TIW Participants received roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL. | 24 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW Participants received roxadustat capsules for 24 weeks. Initial roxadustat dose was based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants received 70, 100, and 150 mg roxadustat, respectively). Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from BIW to QW at the time of the initial Hb response. | 24 |
| Cohort F: Roxadustat at 70 mg BIW Then QW Participants received roxadustat capsules at 70 mg for 24 weeks. Dose adjustments were implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants had a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency was reduced from BIW to QW. | 25 |
| Total | 145 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Death | 1 | 0 | 1 | 0 | 2 | 0 |
| Overall Study | Enrolled into the Extension Study | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 0 | 1 | 1 | 2 |
Baseline characteristics
| Characteristic | Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Cohort C: Roxadustat at 50 mg TIW | Cohort D: Roxadustat at 100 mg TIW | Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Cohort F: Roxadustat at 70 mg BIW Then QW | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 65.9 years STANDARD_DEVIATION 9.3 | 64.3 years STANDARD_DEVIATION 10.3 | 59.2 years STANDARD_DEVIATION 14.7 | 69.8 years STANDARD_DEVIATION 8 | 61.8 years STANDARD_DEVIATION 13.2 | 65.2 years STANDARD_DEVIATION 8.6 | 64.4 years STANDARD_DEVIATION 11.3 |
| Hb | 9.56 g/dL STANDARD_DEVIATION 0.86 | 9.67 g/dL STANDARD_DEVIATION 0.62 | 9.80 g/dL STANDARD_DEVIATION 0.49 | 9.68 g/dL STANDARD_DEVIATION 0.77 | 9.89 g/dL STANDARD_DEVIATION 0.6 | 9.72 g/dL STANDARD_DEVIATION 0.6 | 9.72 g/dL STANDARD_DEVIATION 0.66 |
| Sex: Female, Male Female | 19 Participants | 17 Participants | 16 Participants | 11 Participants | 16 Participants | 13 Participants | 92 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 8 Participants | 13 Participants | 8 Participants | 12 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 15 / 24 | 15 / 24 | 10 / 24 | 10 / 24 | 11 / 24 | 10 / 25 |
| serious Total, serious adverse events | 3 / 24 | 4 / 24 | 4 / 24 | 4 / 24 | 10 / 24 | 10 / 25 |
Outcome results
Primary
Number (%) of Participants With an Hb Response by Week 17
An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL.
Time frame: Up to Week 17
Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With an Hb Response by Week 17 | 19 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With an Hb Response by Week 17 | 24 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With an Hb Response by Week 17 | 21 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With an Hb Response by Week 17 | 23 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With an Hb Response by Week 17 | 23 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With an Hb Response by Week 17 | 21 Participants |
Secondary
Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25
Baseline is defined as the mean of the last 3 available values predose.
Time frame: Baseline, Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)
Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 13 | 2.46 g/dL | Standard Deviation 0.93 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 9 | 2.58 g/dL | Standard Deviation 0.97 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Baseline | 9.56 g/dL | Standard Deviation 0.88 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 17 | 2.63 g/dL | Standard Deviation 0.83 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 5 | 1.71 g/dL | Standard Deviation 1.02 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 5 | 1.11 g/dL | Standard Deviation 0.96 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 9 | 1.77 g/dL | Standard Deviation 1.18 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 13 | 2.06 g/dL | Standard Deviation 1.07 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Baseline | 9.67 g/dL | Standard Deviation 0.62 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 17 | 2.28 g/dL | Standard Deviation 0.87 |
| Cohort C: Roxadustat at 50 mg TIW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 17 | 1.43 g/dL | Standard Deviation 1.15 |
| Cohort C: Roxadustat at 50 mg TIW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Baseline | 9.80 g/dL | Standard Deviation 0.5 |
| Cohort C: Roxadustat at 50 mg TIW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 5 | 0.57 g/dL | Standard Deviation 0.65 |
| Cohort C: Roxadustat at 50 mg TIW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 9 | 0.99 g/dL | Standard Deviation 0.87 |
| Cohort C: Roxadustat at 50 mg TIW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 13 | 1.26 g/dL | Standard Deviation 1.09 |
| Cohort C: Roxadustat at 50 mg TIW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 21 | 1.30 g/dL | Standard Deviation 0.97 |
| Cohort C: Roxadustat at 50 mg TIW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 25 | 1.33 g/dL | Standard Deviation 1 |
| Cohort D: Roxadustat at 100 mg TIW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 9 | 2.21 g/dL | Standard Deviation 1.02 |
| Cohort D: Roxadustat at 100 mg TIW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 5 | 1.65 g/dL | Standard Deviation 0.95 |
| Cohort D: Roxadustat at 100 mg TIW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 25 | 1.73 g/dL | Standard Deviation 1.14 |
| Cohort D: Roxadustat at 100 mg TIW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 13 | 2.17 g/dL | Standard Deviation 1.19 |
| Cohort D: Roxadustat at 100 mg TIW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Baseline | 9.68 g/dL | Standard Deviation 0.77 |
| Cohort D: Roxadustat at 100 mg TIW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 17 | 2.26 g/dL | Standard Deviation 1.31 |
| Cohort D: Roxadustat at 100 mg TIW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 21 | 1.94 g/dL | Standard Deviation 0.81 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 13 | 1.43 g/dL | Standard Deviation 0.9 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Baseline | 9.89 g/dL | Standard Deviation 0.6 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 5 | 0.74 g/dL | Standard Deviation 0.75 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 17 | 1.50 g/dL | Standard Deviation 0.73 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 25 | 1.28 g/dL | Standard Deviation 1.08 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 9 | 1.67 g/dL | Standard Deviation 0.98 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 21 | 1.19 g/dL | Standard Deviation 1.08 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 5 | 0.63 g/dL | Standard Deviation 0.85 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 9 | 0.89 g/dL | Standard Deviation 1.23 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 13 | 1.19 g/dL | Standard Deviation 1.1 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 25 | 1.51 g/dL | Standard Deviation 1.06 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Baseline | 9.72 g/dL | Standard Deviation 0.6 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 17 | 1.46 g/dL | Standard Deviation 1.23 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25 | Change at Week 21 | 1.79 g/dL | Standard Deviation 0.77 |
Secondary
Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24
Baseline was defined as the mean of the last 3 available values predose.
Time frame: Baseline, Weeks 16 (Cohorts A and B End of Treatment) and Week 24 (Cohorts C-F End of Treatment)
Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified timepoint. Last-observation-carried-forward (LOCF) method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24 | Change at Week 16 | 2.42 g/dL | Standard Deviation 1.12 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24 | Baseline | 9.62 g/dL | Standard Deviation 0.92 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24 | Change at Week 16 | 2.32 g/dL | Standard Deviation 1 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24 | Baseline | 9.56 g/dL | Standard Deviation 0.43 |
| Cohort C: Roxadustat at 50 mg TIW | Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24 | Change at Week 16 | 1.85 g/dL | Standard Deviation 1.34 |
| Cohort C: Roxadustat at 50 mg TIW | Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24 | Baseline | 9.68 g/dL | Standard Deviation 0.41 |
| Cohort C: Roxadustat at 50 mg TIW | Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24 | Change at Week 24 | 1.66 g/dL | Standard Deviation 0.45 |
| Cohort D: Roxadustat at 100 mg TIW | Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24 | Change at Week 24 | 1.75 g/dL | Standard Deviation 1.14 |
| Cohort D: Roxadustat at 100 mg TIW | Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24 | Baseline | 9.58 g/dL | Standard Deviation 0.86 |
| Cohort D: Roxadustat at 100 mg TIW | Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24 | Change at Week 16 | 2.21 g/dL | Standard Deviation 1.42 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24 | Change at Week 24 | 1.09 g/dL | Standard Deviation 0.82 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24 | Baseline | 9.96 g/dL | Standard Deviation 0.51 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24 | Change at Week 16 | 1.37 g/dL | Standard Deviation 0.68 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24 | Baseline | 9.75 g/dL | Standard Deviation 0.63 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24 | Change at Week 16 | 1.42 g/dL | Standard Deviation 1.01 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24 | Change at Week 24 | 1.53 g/dL | Standard Deviation 0.88 |
Secondary
Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week
Time frame: Cohorts A and B: Weekly through Week 16 (end of treatment), Week 18 (2 weeks posttreatment), and Week 20 (4 weeks posttreatment); Cohorts C-F: Weekly through Week 24 (end of treatment), Week 26 (2 weeks posttreatment), and Week 28 (4 weeks posttreatment)
Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 1 week | 0.30 g/dL | Standard Deviation 0.579 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 11 weeks | 0.89 g/dL | Standard Deviation 1.088 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 15 weeks | 1.20 g/dL | — |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 12 weeks | 0.91 g/dL | Standard Deviation 1.007 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 4 weeks posttreatment | 0.21 g/dL | Standard Deviation 1.289 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 2 weeks | 0.46 g/dL | Standard Deviation 0.685 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 13 weeks | 1.53 g/dL | Standard Deviation 0.962 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 4 weeks | 0.81 g/dL | Standard Deviation 0.642 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 14 weeks | 2.16 g/dL | Standard Deviation 0.385 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Hb at Response Timepoint | 11.49 g/dL | Standard Deviation 0.414 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 5 weeks | 0.99 g/dL | Standard Deviation 0.705 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 6 weeks | 1.01 g/dL | Standard Deviation 0.999 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 7 weeks | 0.97 g/dL | Standard Deviation 0.874 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 2 weeks posttreatment | 0.49 g/dL | Standard Deviation 1.113 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 8 weeks | 1.05 g/dL | Standard Deviation 0.852 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 9 weeks | 0.88 g/dL | Standard Deviation 0.904 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 3 weeks | 0.67 g/dL | Standard Deviation 0.635 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 10 weeks | 0.88 g/dL | Standard Deviation 1.044 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 13 weeks | 0.90 g/dL | Standard Deviation 0.837 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 2 weeks | 0.05 g/dL | Standard Deviation 0.634 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 4 weeks | 0.17 g/dL | Standard Deviation 0.968 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 14 weeks | 0.94 g/dL | Standard Deviation 0.976 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 1 week | 0.03 g/dL | Standard Deviation 0.562 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 15 weeks | 1.50 g/dL | — |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 5 weeks | 0.20 g/dL | Standard Deviation 1.004 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 6 weeks | 0.23 g/dL | Standard Deviation 0.931 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 2 weeks posttreatment | 0.21 g/dL | Standard Deviation 0.985 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 9 weeks | 0.59 g/dL | Standard Deviation 0.898 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 7 weeks | 0.21 g/dL | Standard Deviation 0.86 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Hb at Response Timepoint | 11.40 g/dL | Standard Deviation 0.289 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 11 weeks | 0.59 g/dL | Standard Deviation 0.644 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 4 weeks posttreatment | -0.28 g/dL | Standard Deviation 0.902 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 10 weeks | 0.68 g/dL | Standard Deviation 0.787 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 12 weeks | 0.69 g/dL | Standard Deviation 0.474 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 3 weeks | 0.19 g/dL | Standard Deviation 0.72 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 8 weeks | 0.45 g/dL | Standard Deviation 0.827 |
| Cohort C: Roxadustat at 50 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 1 week | -0.18 g/dL | Standard Deviation 0.854 |
| Cohort C: Roxadustat at 50 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 11 weeks | 0.39 g/dL | Standard Deviation 0.972 |
| Cohort C: Roxadustat at 50 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 6 weeks | 0.02 g/dL | Standard Deviation 0.821 |
| Cohort C: Roxadustat at 50 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 17 weeks | 0.12 g/dL | Standard Deviation 0.529 |
| Cohort C: Roxadustat at 50 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 15 weeks | 0.13 g/dL | Standard Deviation 0.751 |
| Cohort C: Roxadustat at 50 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 20 weeks | -0.50 g/dL | Standard Deviation 0.283 |
| Cohort C: Roxadustat at 50 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 4 weeks posttreatment | -0.62 g/dL | Standard Deviation 0.846 |
| Cohort C: Roxadustat at 50 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 12 weeks | 0.25 g/dL | Standard Deviation 0.966 |
| Cohort C: Roxadustat at 50 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 13 weeks | 0.13 g/dL | Standard Deviation 1.01 |
| Cohort C: Roxadustat at 50 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 8 weeks | 0.18 g/dL | Standard Deviation 0.82 |
| Cohort C: Roxadustat at 50 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 10 weeks | 0.44 g/dL | Standard Deviation 1.109 |
| Cohort C: Roxadustat at 50 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 3 weeks | -0.02 g/dL | Standard Deviation 0.842 |
| Cohort C: Roxadustat at 50 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 2 weeks | -0.22 g/dL | Standard Deviation 0.868 |
| Cohort C: Roxadustat at 50 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 9 weeks | 0.22 g/dL | Standard Deviation 1.131 |
| Cohort C: Roxadustat at 50 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 14 weeks | 0.18 g/dL | Standard Deviation 0.913 |
| Cohort C: Roxadustat at 50 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 4 weeks | 0.06 g/dL | Standard Deviation 0.767 |
| Cohort C: Roxadustat at 50 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 16 weeks | 0.08 g/dL | Standard Deviation 0.851 |
| Cohort C: Roxadustat at 50 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 22 weeks | 0.90 g/dL | — |
| Cohort C: Roxadustat at 50 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 7 weeks | 0.40 g/dL | Standard Deviation 0.876 |
| Cohort C: Roxadustat at 50 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 18 weeks | -0.06 g/dL | Standard Deviation 0.704 |
| Cohort C: Roxadustat at 50 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 21 weeks | 0.20 g/dL | — |
| Cohort C: Roxadustat at 50 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 5 weeks | -0.07 g/dL | Standard Deviation 0.701 |
| Cohort C: Roxadustat at 50 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Hb at Response Timepoint | 11.32 g/dL | Standard Deviation 0.36 |
| Cohort C: Roxadustat at 50 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 19 weeks | -0.20 g/dL | Standard Deviation 0.807 |
| Cohort C: Roxadustat at 50 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 2 weeks posttreatment | -0.28 g/dL | Standard Deviation 0.614 |
| Cohort D: Roxadustat at 100 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 23 weeks | -1.10 g/dL | — |
| Cohort D: Roxadustat at 100 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 15 weeks | 0.32 g/dL | Standard Deviation 0.815 |
| Cohort D: Roxadustat at 100 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 2 weeks | 0.41 g/dL | Standard Deviation 0.678 |
| Cohort D: Roxadustat at 100 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 19 weeks | 0.33 g/dL | Standard Deviation 0.855 |
| Cohort D: Roxadustat at 100 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 16 weeks | 0.21 g/dL | Standard Deviation 0.808 |
| Cohort D: Roxadustat at 100 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 17 weeks | 0.18 g/dL | Standard Deviation 0.718 |
| Cohort D: Roxadustat at 100 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 18 weeks | 0.39 g/dL | Standard Deviation 0.763 |
| Cohort D: Roxadustat at 100 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 3 weeks | 0.44 g/dL | Standard Deviation 0.873 |
| Cohort D: Roxadustat at 100 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Hb at Response Timepoint | 11.47 g/dL | Standard Deviation 0.43 |
| Cohort D: Roxadustat at 100 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 4 weeks | 0.61 g/dL | Standard Deviation 0.859 |
| Cohort D: Roxadustat at 100 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 2 weeks posttreatment | -0.25 g/dL | Standard Deviation 0.924 |
| Cohort D: Roxadustat at 100 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 5 weeks | 0.65 g/dL | Standard Deviation 0.883 |
| Cohort D: Roxadustat at 100 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 1 week | 0.18 g/dL | Standard Deviation 0.57 |
| Cohort D: Roxadustat at 100 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 6 weeks | 0.67 g/dL | Standard Deviation 0.799 |
| Cohort D: Roxadustat at 100 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 4 weeks posttreatment | -0.80 g/dL | Standard Deviation 0.708 |
| Cohort D: Roxadustat at 100 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 7 weeks | 0.87 g/dL | Standard Deviation 0.882 |
| Cohort D: Roxadustat at 100 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 8 weeks | 0.78 g/dL | Standard Deviation 0.82 |
| Cohort D: Roxadustat at 100 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 14 weeks | 0.37 g/dL | Standard Deviation 0.874 |
| Cohort D: Roxadustat at 100 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 9 weeks | 0.79 g/dL | Standard Deviation 0.96 |
| Cohort D: Roxadustat at 100 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 22 weeks | -1.05 g/dL | Standard Deviation 0.48 |
| Cohort D: Roxadustat at 100 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 10 weeks | 1.01 g/dL | Standard Deviation 0.629 |
| Cohort D: Roxadustat at 100 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 11 weeks | 0.82 g/dL | Standard Deviation 0.678 |
| Cohort D: Roxadustat at 100 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 21 weeks | -0.49 g/dL | Standard Deviation 1.146 |
| Cohort D: Roxadustat at 100 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 12 weeks | 0.60 g/dL | Standard Deviation 0.745 |
| Cohort D: Roxadustat at 100 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 13 weeks | 0.45 g/dL | Standard Deviation 0.808 |
| Cohort D: Roxadustat at 100 mg TIW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 20 weeks | -0.12 g/dL | Standard Deviation 1.035 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 5 weeks | -0.05 g/dL | Standard Deviation 1.295 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Hb at Response Timepoint | 11.62 g/dL | Standard Deviation 0.543 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 1 week | -0.26 g/dL | Standard Deviation 0.709 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 2 weeks | -0.34 g/dL | Standard Deviation 0.72 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 3 weeks | -0.31 g/dL | Standard Deviation 0.934 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 4 weeks | -0.18 g/dL | Standard Deviation 1.08 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 6 weeks | 0.10 g/dL | Standard Deviation 1.274 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 7 weeks | -0.21 g/dL | Standard Deviation 1.255 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 8 weeks | -0.15 g/dL | Standard Deviation 1.238 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 9 weeks | -0.43 g/dL | Standard Deviation 1.075 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 10 weeks | -0.22 g/dL | Standard Deviation 1.226 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 11 weeks | -0.42 g/dL | Standard Deviation 0.966 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 12 weeks | -0.38 g/dL | Standard Deviation 0.818 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 13 weeks | -0.58 g/dL | Standard Deviation 0.946 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 14 weeks | -0.65 g/dL | Standard Deviation 1.079 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 15 weeks | -0.67 g/dL | Standard Deviation 1.191 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 16 weeks | -0.68 g/dL | Standard Deviation 1.262 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 17 weeks | -0.52 g/dL | Standard Deviation 0.984 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 18 weeks | -0.44 g/dL | Standard Deviation 0.699 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 19 weeks | -0.31 g/dL | Standard Deviation 0.888 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 20 weeks | -0.43 g/dL | Standard Deviation 1.275 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 21 weeks | -0.40 g/dL | Standard Deviation 0.849 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 22 weeks | -0.33 g/dL | Standard Deviation 0.839 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 23 weeks | -0.90 g/dL | — |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 2 weeks posttreatment | -0.61 g/dL | Standard Deviation 1.023 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 4 weeks posttreatment | -0.99 g/dL | Standard Deviation 1.296 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 13 weeks | 0.33 g/dL | Standard Deviation 0.88 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 3 weeks | -0.25 g/dL | Standard Deviation 0.682 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 20 weeks | 0.51 g/dL | Standard Deviation 0.839 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 12 weeks | 0.21 g/dL | Standard Deviation 0.774 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 11 weeks | 0.09 g/dL | Standard Deviation 0.974 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 2 weeks | -0.21 g/dL | Standard Deviation 0.707 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 21 weeks | 0.37 g/dL | Standard Deviation 0.737 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 10 weeks | 0.26 g/dL | Standard Deviation 1.018 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 9 weeks | -0.03 g/dL | Standard Deviation 0.944 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 1 week | -0.23 g/dL | Standard Deviation 0.394 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 22 weeks | 0.15 g/dL | Standard Deviation 0.354 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 8 weeks | -0.03 g/dL | Standard Deviation 1.005 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Hb at Response Timepoint | 11.43 g/dL | Standard Deviation 0.348 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 7 weeks | 0.03 g/dL | Standard Deviation 0.83 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 6 weeks | -0.01 g/dL | Standard Deviation 0.937 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 5 weeks | 0.13 g/dL | Standard Deviation 0.752 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 4 weeks | -0.24 g/dL | Standard Deviation 0.794 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 17 weeks | 0.47 g/dL | Standard Deviation 0.751 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 4 weeks posttreatment | -0.79 g/dL | Standard Deviation 0.777 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 18 weeks | 0.27 g/dL | Standard Deviation 0.405 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 16 weeks | 0.41 g/dL | Standard Deviation 0.524 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 15 weeks | 0.18 g/dL | Standard Deviation 0.636 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 2 weeks posttreatment | -0.34 g/dL | Standard Deviation 0.562 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 19 weeks | 0.26 g/dL | Standard Deviation 0.821 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week | Change after 14 weeks | 0.41 g/dL | Standard Deviation 0.778 |
Secondary
Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories
Time frame: Cohorts A and B: Weekly through Week 16 (end of treatment [EoT]) and Week 20 (Follow up [4 weeks posttreatment]); Cohorts C-F: Weekly through Week 24 (EoT) and Week 28 (Follow up [4 weeks posttreatment])
Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | After Response through EoT, Hb Category 11-13 g/dL | 66.73 g/dL | Standard Deviation 27.453 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | After Response through EoT, Hb Category 11-12 g/dL | 31.46 g/dL | Standard Deviation 30.41 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | After Response through EoT, Hb Category <11 g/dL | 11.50 g/dL | Standard Deviation 25.937 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | After Response through EoT, Hb Category 10.5-13 g/dL | 76.80 g/dL | Standard Deviation 23.899 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | In Follow Up, Hb Category <11 g/dL | 16.67 g/dL | Standard Deviation 34.3 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | In Follow Up, Hb Category 11-12 g/dL | 30.56 g/dL | Standard Deviation 38.877 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | In Follow Up, Hb Category 11-13 g/dL | 69.44 g/dL | Standard Deviation 42.492 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | In Follow Up, Hb Category 10.5-13 g/dL | 75.00 g/dL | Standard Deviation 39.295 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | After Response through EoT, Hb Category 10.5-13 g/dL | 87.20 g/dL | Standard Deviation 20.118 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | In Follow Up, Hb Category 10.5-13 g/dL | 83.33 g/dL | Standard Deviation 32.914 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | After Response through EoT, Hb Category <11 g/dL | 18.75 g/dL | Standard Deviation 27.254 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | In Follow Up, Hb Category 11-13 g/dL | 59.52 g/dL | Standard Deviation 40.679 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | In Follow Up, Hb Category 11-12 g/dL | 40.48 g/dL | Standard Deviation 40.679 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | After Response through EoT, Hb Category 11-13 g/dL | 76.05 g/dL | Standard Deviation 26.577 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | After Response through EoT, Hb Category 11-12 g/dL | 48.86 g/dL | Standard Deviation 26.771 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | In Follow Up, Hb Category <11 g/dL | 35.71 g/dL | Standard Deviation 42.258 |
| Cohort C: Roxadustat at 50 mg TIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | After Response through EoT, Hb Category 11-12 g/dL | 46.67 g/dL | Standard Deviation 29.54 |
| Cohort C: Roxadustat at 50 mg TIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | After Response through EoT, Hb Category 11-13 g/dL | 62.10 g/dL | Standard Deviation 31.528 |
| Cohort C: Roxadustat at 50 mg TIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | After Response through EoT, Hb Category 10.5-13 g/dL | 82.69 g/dL | Standard Deviation 25.854 |
| Cohort C: Roxadustat at 50 mg TIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | In Follow Up, Hb Category 10.5-13 g/dL | 66.67 g/dL | Standard Deviation 36.515 |
| Cohort C: Roxadustat at 50 mg TIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | In Follow Up, Hb Category <11 g/dL | 54.76 g/dL | Standard Deviation 41.547 |
| Cohort C: Roxadustat at 50 mg TIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | In Follow Up, Hb Category 11-12 g/dL | 40.48 g/dL | Standard Deviation 40.679 |
| Cohort C: Roxadustat at 50 mg TIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | In Follow Up, Hb Category 11-13 g/dL | 45.24 g/dL | Standard Deviation 41.547 |
| Cohort C: Roxadustat at 50 mg TIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | After Response through EoT, Hb Category <11 g/dL | 35.48 g/dL | Standard Deviation 32.727 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | In Follow Up, Hb Category 11-13 g/dL | 52.17 g/dL | Standard Deviation 43.896 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | In Follow Up, Hb Category 11-12 g/dL | 41.30 g/dL | Standard Deviation 38.883 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | In Follow Up, Hb Category <11 g/dL | 47.83 g/dL | Standard Deviation 43.896 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | After Response through EoT, Hb Category <11 g/dL | 14.03 g/dL | Standard Deviation 18.311 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | After Response through EoT, Hb Category 11-13 g/dL | 74.96 g/dL | Standard Deviation 24.078 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | After Response through EoT, Hb Category 10.5-13 g/dL | 83.50 g/dL | Standard Deviation 21.354 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | In Follow Up, Hb Category 10.5-13 g/dL | 71.74 g/dL | Standard Deviation 39.388 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | After Response through EoT, Hb Category 11-12 g/dL | 41.54 g/dL | Standard Deviation 26.619 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | In Follow Up, Hb Category 10.5-13 g/dL | 65.00 g/dL | Standard Deviation 43.225 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | After Response through EoT, Hb Category <11 g/dL | 38.32 g/dL | Standard Deviation 30.175 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | In Follow Up, Hb Category <11 g/dL | 57.50 g/dL | Standard Deviation 43.755 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | In Follow Up, Hb Category 11-12 g/dL | 30.00 g/dL | Standard Deviation 37.697 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | In Follow Up, Hb Category 11-13 g/dL | 42.50 g/dL | Standard Deviation 43.755 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | After Response through EoT, Hb Category 11-12 g/dL | 44.17 g/dL | Standard Deviation 22.858 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | After Response through EoT, Hb Category 11-13 g/dL | 56.92 g/dL | Standard Deviation 27.338 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | After Response through EoT, Hb Category 10.5-13 g/dL | 79.01 g/dL | Standard Deviation 23.045 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | In Follow Up, Hb Category 10.5-13 g/dL | 73.68 g/dL | Standard Deviation 34.835 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | In Follow Up, Hb Category <11 g/dL | 50.00 g/dL | Standard Deviation 44.096 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | After Response through EoT, Hb Category 11-13 g/dL | 64.39 g/dL | Standard Deviation 32.083 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | After Response through EoT, Hb Category 10.5-13 g/dL | 83.97 g/dL | Standard Deviation 26.219 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | In Follow Up, Hb Category 11-12 g/dL | 47.37 g/dL | Standard Deviation 42.406 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | After Response through EoT, Hb Category 11-12 g/dL | 47.00 g/dL | Standard Deviation 27.692 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | In Follow Up, Hb Category 11-13 g/dL | 50.00 g/dL | Standard Deviation 44.096 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories | After Response through EoT, Hb Category <11 g/dL | 32.56 g/dL | Standard Deviation 33.384 |
Secondary
Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25
The mean percentage of the scheduled weekly Hb values that were \<10.5, \>13, and \>14 g/dL during Weeks 13-17 and 18-25 is presented.
Time frame: Weeks 13-17 (all cohorts) and 18-25 (24-week treatment cohorts only)
Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified timepoint. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 13-17, Hb >13 g/dL | 25.00 percentage of Hb values | Standard Deviation 37.257 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 13-17, Hb >14 g/dL | 2.73 percentage of Hb values | Standard Deviation 9.351 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 13-17, Hb <10.5 g/dL | 15.23 percentage of Hb values | Standard Deviation 33.893 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 13-17, Hb <10.5 g/dL | 7.92 percentage of Hb values | Standard Deviation 20.212 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 13-17, Hb >13 g/dL | 7.50 percentage of Hb values | Standard Deviation 17.508 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 13-17, Hb >14 g/dL | 0 percentage of Hb values | Standard Deviation 0 |
| Cohort C: Roxadustat at 50 mg TIW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 18-25, Hb <10.5 g/dL | 21.97 percentage of Hb values | Standard Deviation 31.809 |
| Cohort C: Roxadustat at 50 mg TIW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 13-17, Hb >14 g/dL | 0 percentage of Hb values | Standard Deviation 0 |
| Cohort C: Roxadustat at 50 mg TIW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 18-25, Hb >13 g/dL | 2.17 percentage of Hb values | Standard Deviation 10.426 |
| Cohort C: Roxadustat at 50 mg TIW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 13-17, Hb >13 g/dL | 4.35 percentage of Hb values | Standard Deviation 14.717 |
| Cohort C: Roxadustat at 50 mg TIW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 13-17, Hb <10.5 g/dL | 25.65 percentage of Hb values | Standard Deviation 36.752 |
| Cohort C: Roxadustat at 50 mg TIW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 18-25, Hb >14 g/dL | 0 percentage of Hb values | Standard Deviation 0 |
| Cohort D: Roxadustat at 100 mg TIW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 13-17, Hb <10.5 g/dL | 9.78 percentage of Hb values | Standard Deviation 24.885 |
| Cohort D: Roxadustat at 100 mg TIW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 18-25, Hb <10.5 g/dL | 9.38 percentage of Hb values | Standard Deviation 22.797 |
| Cohort D: Roxadustat at 100 mg TIW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 13-17, Hb >13 g/dL | 18.26 percentage of Hb values | Standard Deviation 31.283 |
| Cohort D: Roxadustat at 100 mg TIW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 18-25, Hb >13 g/dL | 5.00 percentage of Hb values | Standard Deviation 16.219 |
| Cohort D: Roxadustat at 100 mg TIW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 13-17, Hb >14 g/dL | 0.87 percentage of Hb values | Standard Deviation 4.17 |
| Cohort D: Roxadustat at 100 mg TIW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 18-25, Hb >14 g/dL | 0 percentage of Hb values | Standard Deviation 0 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 18-25, Hb <10.5 g/dL | 23.86 percentage of Hb values | Standard Deviation 33.83 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 13-17, Hb <10.5 g/dL | 9.17 percentage of Hb values | Standard Deviation 19.174 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 13-17, Hb >13 g/dL | 2.95 percentage of Hb values | Standard Deviation 7.662 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 13-17, Hb >14 g/dL | 0 percentage of Hb values | Standard Deviation 0 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 18-25, Hb >13 g/dL | 3.41 percentage of Hb values | Standard Deviation 15.99 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 18-25, Hb >14 g/dL | 0.57 percentage of Hb values | Standard Deviation 2.665 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 18-25, Hb >14 g/dL | 0 percentage of Hb values | Standard Deviation 0 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 18-25, Hb >13 g/dL | 3.13 percentage of Hb values | Standard Deviation 7.599 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 13-17, Hb <10.5 g/dL | 22.75 percentage of Hb values | Standard Deviation 35.995 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 18-25, Hb <10.5 g/dL | 16.84 percentage of Hb values | Standard Deviation 31.625 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 13-17, Hb >14 g/dL | 0 percentage of Hb values | Standard Deviation 0 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25 | Weeks 13-17, Hb >13 g/dL | 0.87 percentage of Hb values | Standard Deviation 4.17 |
Secondary
Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)
Time frame: Cohorts A and B: Weekly through Week 16 (end of treatment); Cohorts C-F: Weekly through Week 24 (end of treatment)
Population: Safety Population included all participants who received any dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 1 week after response | 2.99 mg/kg | Standard Deviation 1.16 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 5 weeks after response | 2.32 mg/kg | Standard Deviation 0.75 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 9 weeks after response | 2.01 mg/kg | Standard Deviation 0.88 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 6 weeks after response | 2.09 mg/kg | Standard Deviation 0.82 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 7 weeks after response | 2.03 mg/kg | Standard Deviation 0.69 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 8 weeks after response | 2.01 mg/kg | Standard Deviation 0.78 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 11 weeks after response | 2.13 mg/kg | Standard Deviation 0.85 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 2 weeks after response | 2.64 mg/kg | Standard Deviation 1.14 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 3 weeks after response | 2.50 mg/kg | Standard Deviation 0.84 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 12 weeks after response | 2.07 mg/kg | Standard Deviation 0.75 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 13 weeks after response | 1.72 mg/kg | Standard Deviation 0.85 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 4 weeks after response | 2.18 mg/kg | Standard Deviation 0.82 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 10 weeks after response | 2.15 mg/kg | Standard Deviation 0.79 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 2 weeks after response | 2.86 mg/kg | Standard Deviation 1.13 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 12 weeks after response | 2.81 mg/kg | Standard Deviation 0.97 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 14 weeks after response | 2.87 mg/kg | — |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 5 weeks after response | 2.73 mg/kg | Standard Deviation 0.86 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 13 weeks after response | 2.70 mg/kg | Standard Deviation 0.43 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 9 weeks after response | 2.71 mg/kg | Standard Deviation 1.08 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 1 week after response | 3.05 mg/kg | Standard Deviation 1.13 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 3 weeks after response | 2.86 mg/kg | Standard Deviation 1.06 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 11 weeks after response | 2.72 mg/kg | Standard Deviation 1.16 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 8 weeks after response | 2.84 mg/kg | Standard Deviation 0.96 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 4 weeks after response | 2.82 mg/kg | Standard Deviation 0.91 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 7 weeks after response | 2.76 mg/kg | Standard Deviation 0.9 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 6 weeks after response | 2.75 mg/kg | Standard Deviation 0.87 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 10 weeks after response | 2.59 mg/kg | Standard Deviation 1 |
| Cohort C: Roxadustat at 50 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 12 weeks after response | 2.19 mg/kg | Standard Deviation 1.34 |
| Cohort C: Roxadustat at 50 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 2 weeks after response | 2.63 mg/kg | Standard Deviation 1.39 |
| Cohort C: Roxadustat at 50 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 13 weeks after response | 2.19 mg/kg | Standard Deviation 1.34 |
| Cohort C: Roxadustat at 50 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 16 weeks after response | 2.04 mg/kg | Standard Deviation 1.44 |
| Cohort C: Roxadustat at 50 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 14 weeks after response | 2.04 mg/kg | Standard Deviation 1.42 |
| Cohort C: Roxadustat at 50 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 15 weeks after response | 2.04 mg/kg | Standard Deviation 1.44 |
| Cohort C: Roxadustat at 50 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 3 weeks after response | 2.63 mg/kg | Standard Deviation 1.39 |
| Cohort C: Roxadustat at 50 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 6 weeks after response | 2.57 mg/kg | Standard Deviation 1.47 |
| Cohort C: Roxadustat at 50 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 21 weeks after response | 1.65 mg/kg | — |
| Cohort C: Roxadustat at 50 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 4 weeks after response | 2.44 mg/kg | Standard Deviation 1.13 |
| Cohort C: Roxadustat at 50 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 5 weeks after response | 2.54 mg/kg | Standard Deviation 1.52 |
| Cohort C: Roxadustat at 50 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 1 week after response | 2.73 mg/kg | Standard Deviation 1.56 |
| Cohort C: Roxadustat at 50 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 7 weeks after response | 2.65 mg/kg | Standard Deviation 1.51 |
| Cohort C: Roxadustat at 50 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 19 weeks after response | 1.25 mg/kg | Standard Deviation 0.39 |
| Cohort C: Roxadustat at 50 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 8 weeks after response | 2.60 mg/kg | Standard Deviation 1.54 |
| Cohort C: Roxadustat at 50 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 9 weeks after response | 2.35 mg/kg | Standard Deviation 1.22 |
| Cohort C: Roxadustat at 50 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 18 weeks after response | 1.53 mg/kg | Standard Deviation 0.66 |
| Cohort C: Roxadustat at 50 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 10 weeks after response | 2.18 mg/kg | Standard Deviation 1.29 |
| Cohort C: Roxadustat at 50 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 11 weeks after response | 2.18 mg/kg | Standard Deviation 1.29 |
| Cohort C: Roxadustat at 50 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 17 weeks after response | 2.13 mg/kg | Standard Deviation 1.46 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 18 weeks after response | 2.43 mg/kg | Standard Deviation 1.79 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 5 weeks after response | 3.61 mg/kg | Standard Deviation 1.49 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 20 weeks after response | 1.82 mg/kg | Standard Deviation 1.29 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 2 weeks after response | 3.85 mg/kg | Standard Deviation 1.08 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 9 weeks after response | 3.16 mg/kg | Standard Deviation 1.43 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 22 weeks after response | 0.85 mg/kg | — |
| Cohort D: Roxadustat at 100 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 12 weeks after response | 2.65 mg/kg | Standard Deviation 1.4 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 4 weeks after response | 3.81 mg/kg | Standard Deviation 1.36 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 3 weeks after response | 3.53 mg/kg | Standard Deviation 1.13 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 13 weeks after response | 2.65 mg/kg | Standard Deviation 1.42 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 10 weeks after response | 2.96 mg/kg | Standard Deviation 1.36 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 21 weeks after response | 1.13 mg/kg | Standard Deviation 0.42 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 17 weeks after response | 2.51 mg/kg | Standard Deviation 1.67 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 15 weeks after response | 2.68 mg/kg | Standard Deviation 1.51 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 14 weeks after response | 2.69 mg/kg | Standard Deviation 1.52 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 1 week after response | 3.87 mg/kg | Standard Deviation 1.28 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 16 weeks after response | 2.72 mg/kg | Standard Deviation 1.62 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 7 weeks after response | 3.31 mg/kg | Standard Deviation 1.29 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 19 weeks after response | 2.51 mg/kg | Standard Deviation 1.94 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 11 weeks after response | 2.77 mg/kg | Standard Deviation 1.3 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 8 weeks after response | 3.21 mg/kg | Standard Deviation 1.33 |
| Cohort D: Roxadustat at 100 mg TIW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 6 weeks after response | 3.48 mg/kg | Standard Deviation 1.3 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 22 weeks after response | 2.04 mg/kg | — |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 1 week after response | 2.09 mg/kg | Standard Deviation 0.89 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 2 weeks after response | 1.97 mg/kg | Standard Deviation 0.92 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 3 weeks after response | 1.92 mg/kg | Standard Deviation 0.87 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 4 weeks after response | 1.96 mg/kg | Standard Deviation 0.95 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 5 weeks after response | 1.97 mg/kg | Standard Deviation 0.96 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 6 weeks after response | 1.99 mg/kg | Standard Deviation 0.98 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 7 weeks after response | 1.99 mg/kg | Standard Deviation 1 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 8 weeks after response | 2.07 mg/kg | Standard Deviation 1.07 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 9 weeks after response | 2.15 mg/kg | Standard Deviation 1.08 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 10 weeks after response | 2.13 mg/kg | Standard Deviation 1.09 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 11 weeks after response | 2.02 mg/kg | Standard Deviation 0.89 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 12 weeks after response | 1.89 mg/kg | Standard Deviation 0.93 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 13 weeks after response | 1.70 mg/kg | Standard Deviation 0.58 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 14 weeks after response | 1.71 mg/kg | Standard Deviation 0.54 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 15 weeks after response | 1.70 mg/kg | Standard Deviation 0.56 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 16 weeks after response | 1.66 mg/kg | Standard Deviation 0.53 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 17 weeks after response | 1.66 mg/kg | Standard Deviation 0.5 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 18 weeks after response | 1.57 mg/kg | Standard Deviation 0.5 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 19 weeks after response | 1.63 mg/kg | Standard Deviation 0.58 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 20 weeks after response | 1.49 mg/kg | Standard Deviation 0.7 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 21 weeks after response | 1.36 mg/kg | Standard Deviation 0.8 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 11 weeks after response | 2.14 mg/kg | Standard Deviation 0.93 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 10 weeks after response | 2.16 mg/kg | Standard Deviation 0.89 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 2 weeks after response | 2.50 mg/kg | Standard Deviation 1.02 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 17 weeks after response | 1.82 mg/kg | Standard Deviation 0.89 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 9 weeks after response | 2.23 mg/kg | Standard Deviation 0.86 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 8 weeks after response | 2.14 mg/kg | Standard Deviation 0.8 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 5 weeks after response | 2.57 mg/kg | Standard Deviation 1.05 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 18 weeks after response | 1.83 mg/kg | Standard Deviation 0.94 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 7 weeks after response | 2.33 mg/kg | Standard Deviation 0.94 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 6 weeks after response | 2.53 mg/kg | Standard Deviation 1.16 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 21 weeks after response | 1.28 mg/kg | Standard Deviation 0.24 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 19 weeks after response | 1.89 mg/kg | Standard Deviation 0.98 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 4 weeks after response | 2.62 mg/kg | Standard Deviation 1.14 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 1 week after response | 2.59 mg/kg | Standard Deviation 0.9 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 14 weeks after response | 1.83 mg/kg | Standard Deviation 0.87 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 20 weeks after response | 1.36 mg/kg | Standard Deviation 0.4 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 15 weeks after response | 1.85 mg/kg | Standard Deviation 0.91 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 13 weeks after response | 1.95 mg/kg | Standard Deviation 0.83 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 12 weeks after response | 1.87 mg/kg | Standard Deviation 0.82 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 3 weeks after response | 2.47 mg/kg | Standard Deviation 0.99 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | 16 weeks after response | 1.76 mg/kg | Standard Deviation 0.72 |
Secondary
Median Initial Hb Responsive Dose: Dose at Which Initial Hb Increases to ≥1.0 g/dL From Baseline
Time frame: Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F)
Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Median Initial Hb Responsive Dose: Dose at Which Initial Hb Increases to ≥1.0 g/dL From Baseline | 2.30 mg/kg/week |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Median Initial Hb Responsive Dose: Dose at Which Initial Hb Increases to ≥1.0 g/dL From Baseline | 2.50 mg/kg/week |
| Cohort C: Roxadustat at 50 mg TIW | Median Initial Hb Responsive Dose: Dose at Which Initial Hb Increases to ≥1.0 g/dL From Baseline | 2.32 mg/kg/week |
| Cohort D: Roxadustat at 100 mg TIW | Median Initial Hb Responsive Dose: Dose at Which Initial Hb Increases to ≥1.0 g/dL From Baseline | 2.36 mg/kg/week |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Median Initial Hb Responsive Dose: Dose at Which Initial Hb Increases to ≥1.0 g/dL From Baseline | 1.96 mg/kg/week |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Median Initial Hb Responsive Dose: Dose at Which Initial Hb Increases to ≥1.0 g/dL From Baseline | 1.61 mg/kg/week |
Secondary
Median Initial Hb Responsive Time: Time to Initial Hb Increase ≥1.0 g/dL From Baseline
Median time to response was estimated using Kaplan Meier method; Cohort A and B censored at Week 17 and Cohort C, D, E, and F censored at Week 25. The median number of days presented was calculated from Baseline to the day the Hb response was achieved.
Time frame: Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C, D, E, and F)
Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Median Initial Hb Responsive Time: Time to Initial Hb Increase ≥1.0 g/dL From Baseline | 21.0 days |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Median Initial Hb Responsive Time: Time to Initial Hb Increase ≥1.0 g/dL From Baseline | 21.6 days |
| Cohort C: Roxadustat at 50 mg TIW | Median Initial Hb Responsive Time: Time to Initial Hb Increase ≥1.0 g/dL From Baseline | 42.0 days |
| Cohort D: Roxadustat at 100 mg TIW | Median Initial Hb Responsive Time: Time to Initial Hb Increase ≥1.0 g/dL From Baseline | 21.0 days |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Median Initial Hb Responsive Time: Time to Initial Hb Increase ≥1.0 g/dL From Baseline | 35.0 days |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Median Initial Hb Responsive Time: Time to Initial Hb Increase ≥1.0 g/dL From Baseline | 42.0 days |
Secondary
Median Time to Hb Response: Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL
Median time to response was estimated using Kaplan Meier method, Cohort A and B censored at Week 17, Cohort C, D, E, and F censored at Week 25. The median number of days presented was calculated from Baseline to the day the Hb response was achieved.
Time frame: Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F)
Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Median Time to Hb Response: Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL | 28.0 days |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Median Time to Hb Response: Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL | 28.0 days |
| Cohort C: Roxadustat at 50 mg TIW | Median Time to Hb Response: Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL | 48.9 days |
| Cohort D: Roxadustat at 100 mg TIW | Median Time to Hb Response: Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL | 28.0 days |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Median Time to Hb Response: Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL | 35.0 days |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Median Time to Hb Response: Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL | 56.0 days |
Secondary
Number (%) of Participants Requiring Rescue Therapy
Rescue treatment included recombinant erythropoiesis-stimulating agent (ESA), red blood cell transfusion (in the absence of a known bleeding episode or surgical blood loss), or intravenous (IV) Iron
Time frame: Baseline up to Week 28 (end of study)
Population: Safety Population included all participants who received any dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants Requiring Rescue Therapy | Blood Transfusion | 0 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants Requiring Rescue Therapy | IV Iron | 0 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants Requiring Rescue Therapy | ESA | 0 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants Requiring Rescue Therapy | ESA | 1 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants Requiring Rescue Therapy | IV Iron | 1 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants Requiring Rescue Therapy | Blood Transfusion | 2 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants Requiring Rescue Therapy | ESA | 0 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants Requiring Rescue Therapy | Blood Transfusion | 0 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants Requiring Rescue Therapy | IV Iron | 0 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants Requiring Rescue Therapy | Blood Transfusion | 1 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants Requiring Rescue Therapy | IV Iron | 1 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants Requiring Rescue Therapy | ESA | 0 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants Requiring Rescue Therapy | Blood Transfusion | 2 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants Requiring Rescue Therapy | ESA | 1 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants Requiring Rescue Therapy | IV Iron | 2 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants Requiring Rescue Therapy | Blood Transfusion | 0 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants Requiring Rescue Therapy | ESA | 2 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants Requiring Rescue Therapy | IV Iron | 2 Participants |
Secondary
Number (%) of Participants Requiring Therapeutic Phlebotomy
Time frame: Baseline up to Week 28 (end of study)
Population: Safety Population included all participants who received any dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants Requiring Therapeutic Phlebotomy | 0 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants Requiring Therapeutic Phlebotomy | 0 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants Requiring Therapeutic Phlebotomy | 0 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants Requiring Therapeutic Phlebotomy | 0 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants Requiring Therapeutic Phlebotomy | 0 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants Requiring Therapeutic Phlebotomy | 0 Participants |
Secondary
Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25
Participants can have a Hb value for the same category (11-12, 11-13, or 10.5-13 g/dL) reported for multiple weeks.
Time frame: Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)
Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 5 | 17 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 17 | 20 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 13 | 19 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 17 | 19 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 9 | 19 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 9 | 18 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 5 | 16 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 9 | 11 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 13 | 18 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 5 | 9 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 17 | 12 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 13 | 11 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 13 | 23 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 5 | 14 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 17 | 20 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 9 | 22 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 5 | 20 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 17 | 24 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 17 | 24 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 5 | 11 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 13 | 23 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 9 | 16 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 9 | 21 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 13 | 19 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 9 | 19 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 17 | 21 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 13 | 17 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 13 | 20 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 9 | 14 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 5 | 5 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 5 | 12 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 13 | 14 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 21 | 17 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 25 | 21 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 5 | 6 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 9 | 11 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 21 | 20 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 21 | 22 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 25 | 22 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 17 | 19 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 17 | 16 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 25 | 23 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 17 | 14 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 9 | 21 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 13 | 23 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 17 | 23 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 21 | 24 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 25 | 24 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 5 | 8 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 9 | 11 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 13 | 13 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 21 | 15 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 25 | 18 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 5 | 14 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 9 | 19 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 13 | 21 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 17 | 22 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 21 | 22 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 25 | 23 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 5 | 17 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 9 | 19 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 17 | 23 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 13 | 17 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 5 | 11 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 5 | 17 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 21 | 23 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 9 | 15 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 17 | 23 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 13 | 22 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 13 | 21 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 25 | 23 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 21 | 19 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 9 | 18 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 17 | 17 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 25 | 23 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 25 | 20 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 5 | 13 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 21 | 23 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 5 | 10 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 13 | 21 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 9 | 14 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 9 | 14 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 5 | 10 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 25 | 24 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 9 | 19 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 13 | 17 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 21 | 23 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 17 | 21 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 17 | 23 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 21 | 22 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 10.5-13 g/dL by Week 5 | 14 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 17 | 20 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 21 | 22 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-13 g/dL by Week 25 | 22 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 25 | 22 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25 | Hb Value of 11-12 g/dL by Week 13 | 17 Participants |
Secondary
Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28
Time frame: Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only)
Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 11-12 g/dL | 0 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 10.5-13 g/dL | 16 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 11-13 g/dL | 12 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 11-13 g/dL | 13 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 10.5-13 g/dL | 14 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 10.5-13 g/dL | 13 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 11-13 g/dL | 0 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 10.5-13 g/dL | 15 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 11-12 g/dL | 7 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 11-13 g/dL | 12 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 11-13 g/dL | 14 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 11-12 g/dL | 5 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 10.5-13 g/dL | 0 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 11-12 g/dL | 4 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 11-12 g/dL | 8 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 11-12 g/dL | 11 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 11-13 g/dL | 14 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 10.5-13 g/dL | 23 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 11-12 g/dL | 11 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 11-13 g/dL | 22 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 10.5-13 g/dL | 20 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 11-12 g/dL | 16 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 11-12 g/dL | 0 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 10.5-13 g/dL | 21 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 11-13 g/dL | 17 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 11-13 g/dL | 0 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 11-13 g/dL | 19 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 11-12 g/dL | 12 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 10.5-13 g/dL | 0 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 10.5-13 g/dL | 17 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of 11-13 g/dL | 8 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 11-13 g/dL | 12 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 10.5-13 g/dL | 17 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 11-12 g/dL | 10 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 11-13 g/dL | 12 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 10.5-13 g/dL | 16 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of 11-12 g/dL | 14 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of 11-13 g/dL | 16 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of 10.5-13 g/dL | 20 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of 11-12 g/dL | 12 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of 11-13 g/dL | 15 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of 10.5-13 g/dL | 20 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of 11-12 g/dL | 5 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of 10.5-13 g/dL | 13 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 11-12 g/dL | 5 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 11-13 g/dL | 8 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 10.5-13 g/dL | 14 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 11-12 g/dL | 7 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 11-13 g/dL | 10 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 10.5-13 g/dL | 16 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 11-12 g/dL | 10 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 11-13 g/dL | 13 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 10.5-13 g/dL | 19 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 11-12 g/dL | 9 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 10.5-13 g/dL | 20 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 10.5-13 g/dL | 20 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 10.5-13 g/dL | 16 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of 10.5-13 g/dL | 22 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 10.5-13 g/dL | 18 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of 10.5-13 g/dL | 21 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 11-12 g/dL | 10 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 11-13 g/dL | 16 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of 10.5-13 g/dL | 19 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of 11-13 g/dL | 22 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 11-12 g/dL | 8 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of 11-12 g/dL | 9 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 11-13 g/dL | 19 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 11-13 g/dL | 15 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 11-12 g/dL | 9 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of 11-13 g/dL | 18 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 10.5-13 g/dL | 16 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of 11-12 g/dL | 17 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 11-12 g/dL | 10 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 11-12 g/dL | 7 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 11-13 g/dL | 12 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of 11-12 g/dL | 12 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of 11-13 g/dL | 13 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 11-13 g/dL | 20 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 11-13 g/dL | 17 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of 10.5-13 g/dL | 14 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of 11-12 g/dL | 4 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of 11-13 g/dL | 7 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of 11-12 g/dL | 14 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 11-12 g/dL | 8 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 11-13 g/dL | 12 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 10.5-13 g/dL | 18 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 10.5-13 g/dL | 16 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of 10.5-13 g/dL | 14 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 11-13 g/dL | 12 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 10.5-13 g/dL | 22 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 11-12 g/dL | 10 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 11-13 g/dL | 12 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 11-12 g/dL | 9 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 10.5-13 g/dL | 17 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 10.5-13 g/dL | 20 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 11-12 g/dL | 15 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of 11-13 g/dL | 14 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of 10.5-13 g/dL | 18 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 11-12 g/dL | 13 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of 11-12 g/dL | 10 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of 11-13 g/dL | 11 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 11-13 g/dL | 18 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 10.5-13 g/dL | 15 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 10.5-13 g/dL | 17 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of 11-12 g/dL | 8 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 11-13 g/dL | 6 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 10.5-13 g/dL | 20 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of 11-13 g/dL | 18 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 11-12 g/dL | 11 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 11-12 g/dL | 4 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of 11-12 g/dL | 17 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of 11-12 g/dL | 15 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of 11-13 g/dL | 20 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 11-13 g/dL | 13 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of 11-13 g/dL | 12 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 11-12 g/dL | 8 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 11-12 g/dL | 8 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 10.5-13 g/dL | 18 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 11-13 g/dL | 14 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 11-13 g/dL | 15 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 11-13 g/dL | 11 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of 10.5-13 g/dL | 22 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of 10.5-13 g/dL | 16 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 11-12 g/dL | 7 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 10.5-13 g/dL | 13 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of 10.5-13 g/dL | 21 Participants |
Secondary
Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25
An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL.
Time frame: Up to Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)
Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 5 | 15 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 9 | 18 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 13 | 18 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 17 | 19 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 13 | 23 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 9 | 21 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 5 | 14 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 17 | 24 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 21 | 19 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 17 | 17 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 5 | 3 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 25 | 21 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 9 | 12 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 13 | 15 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 13 | 21 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 5 | 13 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 9 | 20 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 17 | 22 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 21 | 22 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 25 | 23 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 5 | 9 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 13 | 20 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 17 | 23 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 25 | 23 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 21 | 23 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 9 | 18 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 9 | 13 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 25 | 21 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 5 | 9 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 21 | 21 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 17 | 20 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25 | Week 13 | 16 Participants |
Secondary
Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24
Dose changes include dose reductions, dose increases, and dose holds.
Time frame: Weeks 1-4, 5-12, and 13-16 (all cohorts) and Weeks 17-24 (24-week treatment cohorts only)
Population: Safety Population included all participants who received any dose of study drug. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose held, Weeks 13-16 | 1 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose reduced, Weeks 1-4 | 5 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose increased, Weeks 1-4 | 0 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose held, Weeks 1-4 | 2 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose reduced, Weeks 5-12 | 13 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose increased, Weeks 5-12 | 10 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose held, Weeks 5-12 | 5 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose reduced, Weeks 13-16 | 0 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose increased, Weeks 13-16 | 4 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose held, Weeks 1-4 | 4 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose increased, Weeks 5-12 | 11 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose held, Weeks 5-12 | 2 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose held, Weeks 13-16 | 1 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose reduced, Weeks 1-4 | 1 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose increased, Weeks 1-4 | 0 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose reduced, Weeks 5-12 | 4 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose reduced, Weeks 13-16 | 7 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose increased, Weeks 13-16 | 4 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose reduced, Weeks 5-12 | 2 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose held, Weeks 17-24 | 1 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose reduced, Weeks 1-4 | 0 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose increased, Weeks 17-24 | 2 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose held, Weeks 5-12 | 2 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose increased, Weeks 5-12 | 14 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose reduced, Weeks 13-16 | 4 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose held, Weeks 13-16 | 0 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose held, Weeks 1-4 | 0 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose increased, Weeks 13-16 | 2 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose reduced, Weeks 17-24 | 2 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose increased, Weeks 1-4 | 0 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose held, Weeks 5-12 | 4 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose reduced, Weeks 17-24 | 3 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose reduced, Weeks 1-4 | 2 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose reduced, Weeks 5-12 | 7 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose reduced, Weeks 13-16 | 3 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose increased, Weeks 1-4 | 0 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose increased, Weeks 5-12 | 9 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose increased, Weeks 13-16 | 1 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose increased, Weeks 17-24 | 3 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose held, Weeks 1-4 | 2 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose held, Weeks 13-16 | 1 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose held, Weeks 17-24 | 1 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose held, Weeks 1-4 | 3 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose increased, Weeks 17-24 | 5 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose held, Weeks 5-12 | 3 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose reduced, Weeks 13-16 | 1 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose reduced, Weeks 5-12 | 3 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose held, Weeks 17-24 | 3 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose increased, Weeks 13-16 | 3 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose increased, Weeks 1-4 | 0 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose held, Weeks 13-16 | 2 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose increased, Weeks 5-12 | 9 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose reduced, Weeks 1-4 | 1 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose reduced, Weeks 17-24 | 1 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose reduced, Weeks 17-24 | 2 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose held, Weeks 13-16 | 0 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose increased, Weeks 13-16 | 4 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose reduced, Weeks 5-12 | 5 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose increased, Weeks 17-24 | 0 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose reduced, Weeks 1-4 | 0 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose held, Weeks 17-24 | 0 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose held, Weeks 5-12 | 4 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose reduced, Weeks 13-16 | 0 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose held, Weeks 1-4 | 3 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose increased, Weeks 1-4 | 0 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24 | Dose increased, Weeks 5-12 | 15 Participants |
Secondary
Number (%) of Participants Withdrawn From the Study Due to Inadequate Efficacy
Time frame: Baseline up to Week 28 (end of study)
Population: Safety Population included all participants who received any dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants Withdrawn From the Study Due to Inadequate Efficacy | 0 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants Withdrawn From the Study Due to Inadequate Efficacy | 0 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants Withdrawn From the Study Due to Inadequate Efficacy | 0 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants Withdrawn From the Study Due to Inadequate Efficacy | 0 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants Withdrawn From the Study Due to Inadequate Efficacy | 0 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants Withdrawn From the Study Due to Inadequate Efficacy | 0 Participants |
Secondary
Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Time frame: Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only)
Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 12-13 g/dL | 10 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 13-14 g/dL | 6 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of >14 g/dL | 2 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of >14 g/dL | 1 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of >14 g/dL | 1 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 13-14 g/dL | 6 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 12-13 g/dL | 4 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of <11 g/dL | 4 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of <11 g/dL | 5 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of <11 g/dL | 4 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of <11 g/dL | 4 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of <11 g/dL | 6 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of >14 g/dL | 2 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of >14 g/dL | 4 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 13-14 g/dL | 2 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 12-13 g/dL | 5 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 12-13 g/dL | 6 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 13-14 g/dL | 7 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 13-14 g/dL | 7 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 12-13 g/dL | 4 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 12-13 g/dL | 10 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 13-14 g/dL | 1 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of >14 g/dL | 0 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of <11 g/dL | 1 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of >14 g/dL | 1 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 12-13 g/dL | 9 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of <11 g/dL | 3 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 12-13 g/dL | 6 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of >14 g/dL | 0 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 13-14 g/dL | 1 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 13-14 g/dL | 3 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 13-14 g/dL | 4 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 12-13 g/dL | 9 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of >14 g/dL | 0 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of <11 g/dL | 2 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of <11 g/dL | 2 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of >14 g/dL | 1 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 13-14 g/dL | 4 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 12-13 g/dL | 9 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of <11 g/dL | 9 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of <11 g/dL | 5 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of <11 g/dL | 10 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 12-13 g/dL | 4 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 13-14 g/dL | 0 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of >14 g/dL | 0 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of <11 g/dL | 9 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 12-13 g/dL | 4 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 13-14 g/dL | 1 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of >14 g/dL | 0 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of <11 g/dL | 7 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 12-13 g/dL | 5 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 13-14 g/dL | 2 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of >14 g/dL | 0 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of <11 g/dL | 9 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 12-13 g/dL | 4 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 13-14 g/dL | 2 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of >14 g/dL | 0 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 12-13 g/dL | 4 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 13-14 g/dL | 1 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of >14 g/dL | 0 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of <11 g/dL | 2 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of 12-13 g/dL | 8 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of 13-14 g/dL | 1 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of >14 g/dL | 0 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of <11 g/dL | 2 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of 12-13 g/dL | 6 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of 13-14 g/dL | 1 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of >14 g/dL | 0 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of <11 g/dL | 7 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of 12-13 g/dL | 4 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of 13-14 g/dL | 0 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of >14 g/dL | 0 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of 13-14 g/dL | 6 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of >14 g/dL | 1 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of <11 g/dL | 5 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of <11 g/dL | 6 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 12-13 g/dL | 10 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of 12-13 g/dL | 13 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of <11 g/dL | 1 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 13-14 g/dL | 6 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of <11 g/dL | 4 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of 12-13 g/dL | 4 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 12-13 g/dL | 8 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of <11 g/dL | 2 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of <11 g/dL | 0 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of >14 g/dL | 0 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 12-13 g/dL | 8 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of >14 g/dL | 0 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of 13-14 g/dL | 1 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 12-13 g/dL | 8 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 13-14 g/dL | 3 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 13-14 g/dL | 3 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 13-14 g/dL | 7 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 13-14 g/dL | 6 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of >14 g/dL | 2 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of 12-13 g/dL | 10 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of >14 g/dL | 0 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of 13-14 g/dL | 1 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of >14 g/dL | 1 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of <11 g/dL | 1 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of <11 g/dL | 1 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 12-13 g/dL | 6 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of >14 g/dL | 0 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of >14 g/dL | 3 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of <11 g/dL | 7 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of >14 g/dL | 0 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of >14 g/dL | 0 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of <11 g/dL | 3 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of >14 g/dL | 0 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 12-13 g/dL | 7 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 13-14 g/dL | 1 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 13-14 g/dL | 3 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 12-13 g/dL | 4 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of >14 g/dL | 0 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of <11 g/dL | 3 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of <11 g/dL | 6 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of <11 g/dL | 7 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 13-14 g/dL | 0 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 12-13 g/dL | 5 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of >14 g/dL | 1 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of <11 g/dL | 3 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of 12-13 g/dL | 6 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of 12-13 g/dL | 4 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of 13-14 g/dL | 0 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of >14 g/dL | 1 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of >14 g/dL | 0 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of <11 g/dL | 9 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of 12-13 g/dL | 3 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of 13-14 g/dL | 0 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of >14 g/dL | 0 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 13-14 g/dL | 3 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of <11 g/dL | 2 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 12-13 g/dL | 6 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of 13-14 g/dL | 1 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 12-13 g/dL | 9 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 13-14 g/dL | 3 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of <11 g/dL | 7 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of >14 g/dL | 0 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of 13-14 g/dL | 1 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of <11 g/dL | 4 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of >14 g/dL | 0 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 12-13 g/dL | 3 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of >14 g/dL | 0 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of 12-13 g/dL | 7 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 13-14 g/dL | 0 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 13-14 g/dL | 1 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 13-14 g/dL | 1 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of 12-13 g/dL | 8 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of >14 g/dL | 0 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of >14 g/dL | 0 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of >14 g/dL | 0 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, Hb Value of 12-13 g/dL | 7 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of >14 g/dL | 0 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of <11 g/dL | 8 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of 13-14 g/dL | 0 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of <11 g/dL | 3 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 13-14 g/dL | 2 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of 12-13 g/dL | 5 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of <11 g/dL | 11 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of 12-13 g/dL | 7 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, Hb Value of <11 g/dL | 7 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, Hb Value of <11 g/dL | 4 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, Hb Value of 12-13 g/dL | 6 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of 13-14 g/dL | 4 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, Hb Value of 12-13 g/dL | 3 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, Hb Value of <11 g/dL | 13 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, Hb Value of 13-14 g/dL | 3 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, Hb Value of >14 g/dL | 0 Participants |
Secondary
Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28
Participants can have a Hb value reported for more than 1 of the categories (11-12, 11-13, and 10.5-13 g/dL) during the week intervals since these categories are not mutually exclusive.
Time frame: Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only)
Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, HB Value of 11-12 g/dL | 6 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, HB Value of 11-13 g/dL | 13 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, HB Value of 10.5-13 g/dL | 14 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, HB Value of 10.5-13 g/dL | 13 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, HB Value of 11-12 g/dL | 6 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, HB Value of 11-12 g/dL | 5 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, HB Value of 10.5-13 g/dL | 11 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, HB Value of 11-13 g/dL | 11 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, HB Value of 11-12 g/dL | 4 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, HB Value of 10.5-13 g/dL | 14 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, HB Value of 10.5-13 g/dL | 16 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, HB Value of 11-13 g/dL | 10 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, HB Value of 11-13 g/dL | 12 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, HB Value of 11-13 g/dL | 13 Participants |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, HB Value of 11-12 g/dL | 4 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, HB Value of 11-13 g/dL | 19 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, HB Value of 11-13 g/dL | 19 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, HB Value of 11-13 g/dL | 18 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, HB Value of 10.5-13 g/dL | 22 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, HB Value of 11-12 g/dL | 11 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, HB Value of 10.5-13 g/dL | 21 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, HB Value of 11-12 g/dL | 11 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, HB Value of 10.5-13 g/dL | 19 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, HB Value of 11-13 g/dL | 18 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, HB Value of 11-12 g/dL | 10 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, HB Value of 10.5-13 g/dL | 18 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, HB Value of 11-12 g/dL | 12 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, HB Value of 10.5-13 g/dL | 21 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, HB Value of 11-12 g/dL | 9 Participants |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, HB Value of 11-13 g/dL | 14 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, HB Value of 11-12 g/dL | 7 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, HB Value of 10.5-13 g/dL | 14 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, HB Value of 10.5-13 g/dL | 18 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, HB Value of 10.5-13 g/dL | 17 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, HB Value of 11-12 g/dL | 12 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, HB Value of 11-13 g/dL | 9 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, HB Value of 11-13 g/dL | 13 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, HB Value of 11-13 g/dL | 11 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, HB Value of 10.5-13 g/dL | 16 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, HB Value of 11-12 g/dL | 8 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, HB Value of 10.5-13 g/dL | 16 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, HB Value of 11-13 g/dL | 11 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, HB Value of 11-12 g/dL | 10 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, HB Value of 10.5-13 g/dL | 15 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, HB Value of 11-12 g/dL | 9 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, HB Value of 10.5-13 g/dL | 19 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, HB Value of 11-13 g/dL | 10 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, HB Value of 10.5-13 g/dL | 14 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, HB Value of 11-12 g/dL | 7 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, HB Value of 11-13 g/dL | 13 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, HB Value of 11-12 g/dL | 9 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, HB Value of 11-13 g/dL | 11 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, HB Value of 11-12 g/dL | 11 Participants |
| Cohort C: Roxadustat at 50 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, HB Value of 11-13 g/dL | 7 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, HB Value of 11-13 g/dL | 12 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, HB Value of 11-13 g/dL | 20 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, HB Value of 11-13 g/dL | 16 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, HB Value of 11-12 g/dL | 8 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, HB Value of 10.5-13 g/dL | 20 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, HB Value of 11-12 g/dL | 11 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, HB Value of 11-12 g/dL | 8 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, HB Value of 11-12 g/dL | 13 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, HB Value of 11-12 g/dL | 8 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, HB Value of 10.5-13 g/dL | 19 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, HB Value of 10.5-13 g/dL | 16 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, HB Value of 11-13 g/dL | 20 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, HB Value of 11-13 g/dL | 16 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, HB Value of 11-12 g/dL | 14 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, HB Value of 10.5-13 g/dL | 22 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, HB Value of 10.5-13 g/dL | 17 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, HB Value of 11-12 g/dL | 8 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, HB Value of 11-13 g/dL | 17 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, HB Value of 11-12 g/dL | 9 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, HB Value of 11-13 g/dL | 18 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, HB Value of 10.5-13 g/dL | 21 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, HB Value of 10.5-13 g/dL | 19 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, HB Value of 11-13 g/dL | 11 Participants |
| Cohort D: Roxadustat at 100 mg TIW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, HB Value of 10.5-13 g/dL | 19 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, HB Value of 11-13 g/dL | 17 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, HB Value of 10.5-13 g/dL | 16 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, HB Value of 11-12 g/dL | 9 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, HB Value of 11-13 g/dL | 12 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, HB Value of 11-12 g/dL | 11 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, HB Value of 11-13 g/dL | 14 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, HB Value of 10.5-13 g/dL | 20 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, HB Value of 11-12 g/dL | 14 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, HB Value of 10.5-13 g/dL | 17 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, HB Value of 10.5-13 g/dL | 20 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, HB Value of 11-12 g/dL | 9 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, HB Value of 11-13 g/dL | 11 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, HB Value of 11-12 g/dL | 10 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, HB Value of 11-13 g/dL | 13 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, HB Value of 10.5-13 g/dL | 17 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, HB Value of 11-12 g/dL | 11 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, HB Value of 11-13 g/dL | 12 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, HB Value of 10.5-13 g/dL | 15 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, HB Value of 11-12 g/dL | 7 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, HB Value of 11-13 g/dL | 9 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, HB Value of 10.5-13 g/dL | 13 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, HB Value of 11-12 g/dL | 6 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, HB Value of 11-13 g/dL | 9 Participants |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, HB Value of 10.5-13 g/dL | 14 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, HB Value of 11-12 g/dL | 7 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, HB Value of 11-12 g/dL | 9 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, HB Value of 10.5-13 g/dL | 17 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, HB Value of 11-12 g/dL | 14 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, HB Value of 10.5-13 g/dL | 18 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, HB Value of 11-13 g/dL | 13 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, HB Value of 11-13 g/dL | 13 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, HB Value of 11-13 g/dL | 18 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 13-16, HB Value of 11-12 g/dL | 9 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, HB Value of 10.5-13 g/dL | 17 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, HB Value of 10.5-13 g/dL | 15 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 21-24, HB Value of 10.5-13 g/dL | 20 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, HB Value of 11-13 g/dL | 11 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-16, HB Value of 11-12 g/dL | 7 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, HB Value of 10.5-13 g/dL | 13 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 25-28, HB Value of 11-12 g/dL | 12 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, HB Value of 11-12 g/dL | 11 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, HB Value of 10.5-13 g/dL | 19 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, HB Value of 11-13 g/dL | 10 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, HB Value of 11-13 g/dL | 17 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-20, HB Value of 11-13 g/dL | 16 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 5-8, HB Value of 11-13 g/dL | 8 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 9-12, HB Value of 11-12 g/dL | 6 Participants |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28 | Weeks 17-24, HB Value of 10.5-13 g/dL | 21 Participants |
Secondary
Weekly Total Dose and Cumulative Total Dose (mg/kg) When First Achieving Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)
Time frame: Cohorts A and B: Weekly through Week 16 (end of treatment); Cohorts C-F: Weekly through Week 24 (end of treatment)
Population: EE Population included all participants who received at least 2 weeks of study drug with a Hb BL and a valid post-BL value at 2 weeks into study. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Weekly Total Dose and Cumulative Total Dose (mg/kg) When First Achieving Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | Weekly Dose | 4.08 mg/kg | Standard Deviation 0.952 |
| Cohort A: Roxadustat Tiered, Weight Based Dosing TIW | Weekly Total Dose and Cumulative Total Dose (mg/kg) When First Achieving Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | Cumulative Dose | 16.86 mg/kg | Standard Deviation 17.097 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Weekly Total Dose and Cumulative Total Dose (mg/kg) When First Achieving Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | Weekly Dose | 4.13 mg/kg | Standard Deviation 0.944 |
| Cohort B: Roxadustat Tiered, Weight Based Dosing TIW Then BIW | Weekly Total Dose and Cumulative Total Dose (mg/kg) When First Achieving Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | Cumulative Dose | 20.05 mg/kg | Standard Deviation 15.994 |
| Cohort C: Roxadustat at 50 mg TIW | Weekly Total Dose and Cumulative Total Dose (mg/kg) When First Achieving Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | Weekly Dose | 2.88 mg/kg | Standard Deviation 1.721 |
| Cohort C: Roxadustat at 50 mg TIW | Weekly Total Dose and Cumulative Total Dose (mg/kg) When First Achieving Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | Cumulative Dose | 24.41 mg/kg | Standard Deviation 23.838 |
| Cohort D: Roxadustat at 100 mg TIW | Weekly Total Dose and Cumulative Total Dose (mg/kg) When First Achieving Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | Weekly Dose | 4.17 mg/kg | Standard Deviation 1.119 |
| Cohort D: Roxadustat at 100 mg TIW | Weekly Total Dose and Cumulative Total Dose (mg/kg) When First Achieving Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | Cumulative Dose | 21.21 mg/kg | Standard Deviation 18.229 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Weekly Total Dose and Cumulative Total Dose (mg/kg) When First Achieving Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | Weekly Dose | 2.65 mg/kg | Standard Deviation 0.886 |
| Cohort E: Roxadustat Tiered, Weight Based Dosing BIW Then QW | Weekly Total Dose and Cumulative Total Dose (mg/kg) When First Achieving Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | Cumulative Dose | 16.57 mg/kg | Standard Deviation 12.154 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Weekly Total Dose and Cumulative Total Dose (mg/kg) When First Achieving Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | Weekly Dose | 3.02 mg/kg | Standard Deviation 0.876 |
| Cohort F: Roxadustat at 70 mg BIW Then QW | Weekly Total Dose and Cumulative Total Dose (mg/kg) When First Achieving Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL) | Cumulative Dose | 22.16 mg/kg | Standard Deviation 17.612 |