Anemia, Chronic Kidney Disease
Conditions
Keywords
Kidney, Chronic Kidney Disease, CKD, Stage 3 or 4 Chronic Kidney Disease, Renal, Anemia, Oral anemia treatment, Hemoglobin levels, Blood count, Erythropoietin
Brief summary
The primary objective of the study is to evaluate the safety, tolerability, and pharmacodynamic effects of different oral doses of roxadustat administered 2 times a week (BIW) or 3 times a week (TIW) for up to 4 weeks to participants with chronic kidney disease (CKD) not requiring dialysis.
Detailed description
This study in participants with CKD not requiring dialysis was conducted in 2 parts (designated Part 1 and Part 2). Part 1 evaluated roxadustat doses at 1.0 and 2.0 milligrams/kilograms (mg/kg). Part 2 evaluated roxadustat doses at 0.7, 1.5, and 2.0 mg/kg. On 08 May 2007, the Food and Drug Administration (FDA) placed a clinical hold on the study until evaluation of a report of a death due to fulminant hepatic failure in a participant with CKD in a FibroGen-sponsored clinical trial of another hypoxia inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) (FG-2216) being investigated for treatment of anemia in participants with CKD and other diseases. The clinical hold resulted in early termination of Part 1 of the study. On 24 March 2008, the FDA lifted the clinical hold and Part 2 of this study started.
Interventions
DRUGRoxadustat
Capsule
DRUGPlacebo
Capsule
Sponsors
Astellas Pharma Inc
Kyntra Bio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 18 to 80 years of age. Participants aged over 75 years but otherwise meet all other participant selection criteria will be evaluated on a case-by-case basis and can be included in this study, per discretion of Sponsor's physician representative such as medical monitor or clinical leader. 2. Chronic Kidney Disease Stage 3 or 4 with hemoglobin \<11.0 grams (g)/deciliter (dL). 3. Normal iron studies. 4. Normal folate and vitamin B12 levels. 5. Liver function tests within normal limits at screening. 6. Absence of active or chronic rectal bleeding. 7. Absence of diagnosis of age-related macular degeneration (AMD), diabetic macular edema, or diabetic proliferative retinopathy that is likely to require treatment during the trial. 8. Female participants must not be pregnant nor breastfeeding and agree to use acceptable method of contraception. 9. Male participants with partners who can have children must agree to use a medically acceptable method of contraception.
Exclusion criteria
1. Seropositive for HIV. 2. History of chronic liver disease. 3. History of polycystic kidney disease (PKD). 4. Uncontrolled hypertension (diastolic BP \>110 millimeter of mercury (mmHg) or systolic BP \>170 mmHg at screening). 5. New York Heart Association Class III or IV congestive heart failure. 6. Recent myocardial infarction or acute coronary syndrome. 7. History of myelodysplastic syndrome. 8. Any history of malignancy or a known genetic predisposition for developing cancer (for example, with diagnostic markers suggesting a genetic predisposition of cancer) except for curatively resected basal cell carcinoma of skin, squamous cell carcinoma of skin, cervical carcinoma in situ, or resected benign colonic polyps. 9. Active inflammatory infection or chronic inflammatory disease. 10. Any clinically significant and uncontrolled medical condition considered a high risk for participation in an investigational study. 11. Blood clots within 4 weeks. 12. History of ongoing hemolysis or diagnosis of hemolytic syndrome. 13. Known history of bone marrow fibrosis. 14. History of hemosiderosis or hemochromatosis. 15. Androgen therapy within 12 weeks. 16. Red blood cell transfusion within 12 weeks. 17. Therapy with an erythropoiesis stimulating agent (ESA) such as human recombinant erythropoietin within the past 60 days. 18. Intravenous iron supplementation within the past 60 days. 19. Currently taking dapsone or acetaminophen \>2.6 g/day. 20. History of prior organ transplantation. 21. Alcohol consumption greater than 3 or more drinks per day within the past year. 22. Use of an investigational medication or participation in an investigational study within 4 weeks preceding Day 1. 23. Positive urine toxicology screen for a substance that has not been prescribed for the participant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Baseline up to Week 16 (End of Study (EoS]) | An adverse event (AE) was any untoward medical event in a participant who received study drug whether or not the event is considered drug related. TEAEs defined as an AE beginning after first dose of study drug until 28 days after last dose of study drug or existing AEs that worsened after first dose of study drug until the participant's last study visit. Severe AEs defined as incapacitating, inability to perform usual activities. Drug-related TEAEs defined as TEAEs with possible, probable, or definite relationship to study drug. Serious AE criteria included death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed here. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
| Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) | Baseline, End of Treatment (EoT) (Day 26 for TIW Dosing or Day 29 for BIW Dosing) | Mean Hb change from baseline was analyzed by treatment group and study visit. Baseline was defined as the mean of last 3 available values prior to the first dose. |
| Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) | Baseline, Week 8 (2 Weeks of Follow Up) | Mean Hb change from baseline was analyzed by treatment group and study visit. Baseline is defined as the mean of last 3 available values prior to the first dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Baseline up to Day 26-29 (EoT), up to Week 8 (2 weeks of follow up), and up to Week 16 (EoS, 4 weeks of follow up) | Hb response defined as an increase in Hb from baseline by ≥1.0 g/dL (not due to red blood cell transfusion or IV iron supplementation during treatment). The baseline for Hb was defined as the mean of the last 3 available Hb values obtained prior to the first dose. |
| Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1 | Baseline, 4, 8, 12, and 24 hours on Day 1 | Baseline is defined as the last value obtained prior to the first dose. |
| Plasma Roxadustat Concentration (Part 2) | Predose on Days 3 (TIW dose groups) or 4 (BIW dose groups), 8, 15, 22, and 26 (TIW dose groups) or 29 (BIW dose groups) | — |
| Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Baseline (Day 1), 1, 2, 3, 4, 6, 8, 12, 18, 24, 48, and 72 hours on Day 26 (TIW Dosing) or Day 29 (BIW Dosing) | Baseline is defined as the last value obtained prior to the first dose. |
Countries
United States
Participant flow
Pre-assignment details
On 08 May 2007, the Food and Drug Administration (FDA) placed a clinical hold on the study. The clinical hold resulted in early termination of Part 1 of the study. On 24 March 2008, the FDA lifted the clinical hold and Part 2 of this study started.
Participants by arm
| Arm | Count |
|---|---|
| Roxadustat 0.7 mg/kg BIW Participants received roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | 10 |
| Roxadustat 0.7 mg/kg TIW Participants received roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | 13 |
| Roxadustat 1.0 mg/kg BIW Participants received roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days. | 12 |
| Roxadustat 1.0 mg/kg TIW Participants received roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days. | 9 |
| Roxadustat 1.5 mg/kg BIW Participants received roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | 10 |
| Roxadustat 1.5 mg/kg TIW Participants received roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | 11 |
| Roxadustat 2.0 mg/kg BIW Participants received roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. | 11 |
| Roxadustat 2.0 mg/kg TIW Participants received roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. | 12 |
| Placebo Participants received placebo orally, matching to the roxadustat dose, number of days per week, and duration. | 28 |
| Total | 116 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 (up to Day 57) | Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Part 1 (up to Day 57) | Sponsor Decision | 0 | 0 | 3 | 4 | 0 | 0 | 1 | 1 | 1 |
| Part 1 (up to Day 57) | Withdrawal by Subject | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Part 2 (up to Day 114) | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Roxadustat 0.7 mg/kg BIW | Roxadustat 0.7 mg/kg TIW | Roxadustat 1.0 mg/kg BIW | Roxadustat 1.0 mg/kg TIW | Roxadustat 1.5 mg/kg BIW | Roxadustat 1.5 mg/kg TIW | Roxadustat 2.0 mg/kg BIW | Roxadustat 2.0 mg/kg TIW | Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 64.6 years STANDARD_DEVIATION 4.9 | 60.6 years STANDARD_DEVIATION 9.2 | 69.5 years STANDARD_DEVIATION 7.7 | 67.0 years STANDARD_DEVIATION 8.4 | 63.8 years STANDARD_DEVIATION 8.8 | 63.5 years STANDARD_DEVIATION 6.4 | 64.3 years STANDARD_DEVIATION 9 | 66.8 years STANDARD_DEVIATION 7.8 | 68.6 years STANDARD_DEVIATION 6.2 | 65.8 years STANDARD_DEVIATION 7.8 |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 8 Participants | 3 Participants | 6 Participants | 10 Participants | 8 Participants | 9 Participants | 12 Participants | 67 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 4 Participants | 6 Participants | 4 Participants | 1 Participants | 3 Participants | 3 Participants | 16 Participants | 49 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 | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 10 | 9 / 13 | 7 / 12 | 5 / 9 | 9 / 10 | 7 / 11 | 7 / 11 | 5 / 12 | 12 / 28 |
| serious Total, serious adverse events | 0 / 10 | 4 / 13 | 0 / 12 | 0 / 9 | 0 / 10 | 0 / 11 | 0 / 11 | 0 / 12 | 1 / 28 |
Outcome results
Primary
Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment)
Mean Hb change from baseline was analyzed by treatment group and study visit. Baseline was defined as the mean of last 3 available values prior to the first dose.
Time frame: Baseline, End of Treatment (EoT) (Day 26 for TIW Dosing or Day 29 for BIW Dosing)
Population: Part 1 and Part 2 EE Population: Participants who were anemic at baseline (Hb ≤11.0 g/dL and were in study treatment for at least 2.5 weeks with corresponding Hb values. Last-observation-carried-forward (LOCF) method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Roxadustat 0.7 mg/kg BIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) | Baseline | 10.32 g/dL | Standard Deviation 0.678 |
| Roxadustat 0.7 mg/kg BIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) | Change at Day 26-29 | 0.25 g/dL | Standard Deviation 0.849 |
| Roxadustat 0.7 mg/kg TIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) | Change at Day 26-29 | 0.60 g/dL | Standard Deviation 0.756 |
| Roxadustat 0.7 mg/kg TIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) | Baseline | 10.03 g/dL | Standard Deviation 0.709 |
| Roxadustat 1.0 mg/kg BIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) | Baseline | 9.18 g/dL | Standard Deviation 0.6 |
| Roxadustat 1.0 mg/kg BIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) | Change at Day 26-29 | 0.44 g/dL | Standard Deviation 0.781 |
| Roxadustat 1.0 mg/kg TIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) | Baseline | 10.35 g/dL | Standard Deviation 0.849 |
| Roxadustat 1.0 mg/kg TIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) | Change at Day 26-29 | 0.21 g/dL | Standard Deviation 1.016 |
| Roxadustat 1.5 mg/kg BIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) | Baseline | 10.28 g/dL | Standard Deviation 0.551 |
| Roxadustat 1.5 mg/kg BIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) | Change at Day 26-29 | 1.22 g/dL | Standard Deviation 1.112 |
| Roxadustat 1.5 mg/kg TIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) | Baseline | 10.08 g/dL | Standard Deviation 0.65 |
| Roxadustat 1.5 mg/kg TIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) | Change at Day 26-29 | 1.65 g/dL | Standard Deviation 1.033 |
| Roxadustat 2.0 mg/kg BIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) | Baseline | 9.97 g/dL | Standard Deviation 0.43 |
| Roxadustat 2.0 mg/kg BIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) | Change at Day 26-29 | 1.35 g/dL | Standard Deviation 0.577 |
| Roxadustat 2.0 mg/kg TIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) | Baseline | 9.93 g/dL | Standard Deviation 0.806 |
| Roxadustat 2.0 mg/kg TIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) | Change at Day 26-29 | 1.75 g/dL | Standard Deviation 1.2 |
| Placebo | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) | Change at Day 26-29 | -0.05 g/dL | Standard Deviation 0.5 |
| Placebo | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment) | Baseline | 10.10 g/dL | Standard Deviation 0.616 |
Comparison: P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.p-value: 0.2073t-test, 2 sided
Comparison: P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.p-value: 0.0046t-test, 2 sided
Comparison: P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.p-value: 0.086t-test, 2 sided
Comparison: P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.p-value: 0.4005t-test, 2 sided
Comparison: P-value is presented for Day 26-29 timepoint. P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.p-value: <0.0001t-test, 2 sided
Comparison: P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.p-value: <0.0001t-test, 2 sided
Comparison: P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.p-value: <0.0001t-test, 2 sided
Comparison: P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.p-value: <0.0001t-test, 2 sided
Primary
Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up)
Mean Hb change from baseline was analyzed by treatment group and study visit. Baseline is defined as the mean of last 3 available values prior to the first dose.
Time frame: Baseline, Week 8 (2 Weeks of Follow Up)
Population: Part 1 and Part 2 EE Population: Participants who were anemic at baseline (Hb ≤11.0 g/dL and were in study treatment for at least 2.5 weeks with corresponding Hb values. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Roxadustat 0.7 mg/kg BIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) | Change at Week 8 | 0.59 g/dL | Standard Deviation 0.808 |
| Roxadustat 0.7 mg/kg BIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) | Baseline | 10.32 g/dL | Standard Deviation 0.678 |
| Roxadustat 0.7 mg/kg TIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) | Change at Week 8 | 0.24 g/dL | Standard Deviation 0.846 |
| Roxadustat 0.7 mg/kg TIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) | Baseline | 10.03 g/dL | Standard Deviation 0.709 |
| Roxadustat 1.0 mg/kg BIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) | Baseline | 9.18 g/dL | Standard Deviation 0.6 |
| Roxadustat 1.0 mg/kg BIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) | Change at Week 8 | 0.50 g/dL | Standard Deviation 0.356 |
| Roxadustat 1.0 mg/kg TIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) | Baseline | 10.35 g/dL | Standard Deviation 0.849 |
| Roxadustat 1.0 mg/kg TIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) | Change at Week 8 | 0.05 g/dL | Standard Deviation 1.435 |
| Roxadustat 1.5 mg/kg BIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) | Change at Week 8 | 0.79 g/dL | Standard Deviation 0.916 |
| Roxadustat 1.5 mg/kg BIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) | Baseline | 10.28 g/dL | Standard Deviation 0.551 |
| Roxadustat 1.5 mg/kg TIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) | Baseline | 10.08 g/dL | Standard Deviation 0.65 |
| Roxadustat 1.5 mg/kg TIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) | Change at Week 8 | 1.31 g/dL | Standard Deviation 0.743 |
| Roxadustat 2.0 mg/kg BIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) | Change at Week 8 | 1.21 g/dL | Standard Deviation 0.656 |
| Roxadustat 2.0 mg/kg BIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) | Baseline | 9.97 g/dL | Standard Deviation 0.43 |
| Roxadustat 2.0 mg/kg TIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) | Baseline | 9.93 g/dL | Standard Deviation 0.806 |
| Roxadustat 2.0 mg/kg TIW | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) | Change at Week 8 | 1.52 g/dL | Standard Deviation 0.815 |
| Placebo | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) | Change at Week 8 | 0.04 g/dL | Standard Deviation 0.684 |
| Placebo | Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up) | Baseline | 10.10 g/dL | Standard Deviation 0.616 |
Comparison: P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.p-value: 0.0507t-test, 2 sided
Comparison: P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.p-value: 0.4502t-test, 2 sided
Comparison: P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.p-value: 0.1603t-test, 2 sided
Comparison: P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.p-value: 0.9816t-test, 2 sided
Comparison: P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.p-value: 0.0139t-test, 2 sided
Comparison: P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.p-value: <0.0001t-test, 2 sided
Comparison: P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.p-value: 0.0001t-test, 2 sided
Comparison: P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.p-value: <0.0001t-test, 2 sided
Primary
Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined)
An adverse event (AE) was any untoward medical event in a participant who received study drug whether or not the event is considered drug related. TEAEs defined as an AE beginning after first dose of study drug until 28 days after last dose of study drug or existing AEs that worsened after first dose of study drug until the participant's last study visit. Severe AEs defined as incapacitating, inability to perform usual activities. Drug-related TEAEs defined as TEAEs with possible, probable, or definite relationship to study drug. Serious AE criteria included death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed here. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Baseline up to Week 16 (End of Study (EoS])
Population: Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Roxadustat 0.7 mg/kg BIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Serious TEAEs | 0 Participants |
| Roxadustat 0.7 mg/kg BIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Severe TEAEs | 0 Participants |
| Roxadustat 0.7 mg/kg BIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Any TEAEs | 3 Participants |
| Roxadustat 0.7 mg/kg BIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | TEAEs Leading to Treatment Discontinuation | 0 Participants |
| Roxadustat 0.7 mg/kg BIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Drug-Related TEAEs | 1 Participants |
| Roxadustat 0.7 mg/kg TIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | TEAEs Leading to Treatment Discontinuation | 0 Participants |
| Roxadustat 0.7 mg/kg TIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Drug-Related TEAEs | 2 Participants |
| Roxadustat 0.7 mg/kg TIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Serious TEAEs | 4 Participants |
| Roxadustat 0.7 mg/kg TIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Severe TEAEs | 3 Participants |
| Roxadustat 0.7 mg/kg TIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Any TEAEs | 9 Participants |
| Roxadustat 1.0 mg/kg BIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Severe TEAEs | 1 Participants |
| Roxadustat 1.0 mg/kg BIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Drug-Related TEAEs | 2 Participants |
| Roxadustat 1.0 mg/kg BIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | TEAEs Leading to Treatment Discontinuation | 0 Participants |
| Roxadustat 1.0 mg/kg BIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Serious TEAEs | 0 Participants |
| Roxadustat 1.0 mg/kg BIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Any TEAEs | 7 Participants |
| Roxadustat 1.0 mg/kg TIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Serious TEAEs | 0 Participants |
| Roxadustat 1.0 mg/kg TIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Drug-Related TEAEs | 1 Participants |
| Roxadustat 1.0 mg/kg TIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | TEAEs Leading to Treatment Discontinuation | 1 Participants |
| Roxadustat 1.0 mg/kg TIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Any TEAEs | 5 Participants |
| Roxadustat 1.0 mg/kg TIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Severe TEAEs | 0 Participants |
| Roxadustat 1.5 mg/kg BIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Severe TEAEs | 0 Participants |
| Roxadustat 1.5 mg/kg BIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Drug-Related TEAEs | 3 Participants |
| Roxadustat 1.5 mg/kg BIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Any TEAEs | 9 Participants |
| Roxadustat 1.5 mg/kg BIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | TEAEs Leading to Treatment Discontinuation | 0 Participants |
| Roxadustat 1.5 mg/kg BIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Serious TEAEs | 0 Participants |
| Roxadustat 1.5 mg/kg TIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | TEAEs Leading to Treatment Discontinuation | 0 Participants |
| Roxadustat 1.5 mg/kg TIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Drug-Related TEAEs | 3 Participants |
| Roxadustat 1.5 mg/kg TIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Any TEAEs | 7 Participants |
| Roxadustat 1.5 mg/kg TIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Serious TEAEs | 0 Participants |
| Roxadustat 1.5 mg/kg TIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Severe TEAEs | 1 Participants |
| Roxadustat 2.0 mg/kg BIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Any TEAEs | 7 Participants |
| Roxadustat 2.0 mg/kg BIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Serious TEAEs | 0 Participants |
| Roxadustat 2.0 mg/kg BIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Drug-Related TEAEs | 3 Participants |
| Roxadustat 2.0 mg/kg BIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | TEAEs Leading to Treatment Discontinuation | 1 Participants |
| Roxadustat 2.0 mg/kg BIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Severe TEAEs | 1 Participants |
| Roxadustat 2.0 mg/kg TIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Serious TEAEs | 0 Participants |
| Roxadustat 2.0 mg/kg TIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Drug-Related TEAEs | 1 Participants |
| Roxadustat 2.0 mg/kg TIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Any TEAEs | 5 Participants |
| Roxadustat 2.0 mg/kg TIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | TEAEs Leading to Treatment Discontinuation | 0 Participants |
| Roxadustat 2.0 mg/kg TIW | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Severe TEAEs | 0 Participants |
| Placebo | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Any TEAEs | 13 Participants |
| Placebo | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Drug-Related TEAEs | 3 Participants |
| Placebo | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Serious TEAEs | 1 Participants |
| Placebo | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | Severe TEAEs | 1 Participants |
| Placebo | Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) | TEAEs Leading to Treatment Discontinuation | 1 Participants |
Secondary
Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29
Baseline is defined as the last value obtained prior to the first dose.
Time frame: Baseline (Day 1), 1, 2, 3, 4, 6, 8, 12, 18, 24, 48, and 72 hours on Day 26 (TIW Dosing) or Day 29 (BIW Dosing)
Population: Part 1 Safety Population: Participants who received at least 1 dose of study drug. Participants with missing erythropoietin values at any timepoint were excluded from analysis. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Roxadustat 0.7 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 29, 24 Hour | 10.18 milli-international units (mIU)/mL | Standard Deviation 3.16 |
| Roxadustat 0.7 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 29, 2 Hour | -1.27 milli-international units (mIU)/mL | Standard Deviation 2.23 |
| Roxadustat 0.7 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 29, 18 Hour | 43.80 milli-international units (mIU)/mL | Standard Deviation 13.41 |
| Roxadustat 0.7 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 29, 1 Hour | -1.08 milli-international units (mIU)/mL | Standard Deviation 1.22 |
| Roxadustat 0.7 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 29, 12 Hour | 77.35 milli-international units (mIU)/mL | Standard Deviation 43.8 |
| Roxadustat 0.7 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Day 1, Baseline | 13.46 milli-international units (mIU)/mL | Standard Deviation 5.69 |
| Roxadustat 0.7 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 29, 72 Hour | -2.93 milli-international units (mIU)/mL | Standard Deviation 3.91 |
| Roxadustat 0.7 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 29, 8 Hour | 135.08 milli-international units (mIU)/mL | Standard Deviation 83.95 |
| Roxadustat 0.7 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 29, 6 Hour | 66.85 milli-international units (mIU)/mL | Standard Deviation 43.07 |
| Roxadustat 0.7 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 29, 48 Hour | -5.17 milli-international units (mIU)/mL | Standard Deviation 4.7 |
| Roxadustat 0.7 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 29, 4 Hour | 12.03 milli-international units (mIU)/mL | Standard Deviation 10.12 |
| Roxadustat 0.7 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 29, 3 Hour | -0.55 milli-international units (mIU)/mL | Standard Deviation 1.13 |
| Roxadustat 0.7 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 1 Hour | -1.50 milli-international units (mIU)/mL | Standard Deviation 1.41 |
| Roxadustat 0.7 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Day 1, Baseline | 13.30 milli-international units (mIU)/mL | Standard Deviation 6.59 |
| Roxadustat 0.7 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 12 Hour | 81.80 milli-international units (mIU)/mL | Standard Deviation 81.03 |
| Roxadustat 0.7 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 8 Hour | 57.95 milli-international units (mIU)/mL | Standard Deviation 63.29 |
| Roxadustat 0.7 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 6 Hour | 8.05 milli-international units (mIU)/mL | Standard Deviation 11.81 |
| Roxadustat 0.7 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 18 Hour | 37.30 milli-international units (mIU)/mL | Standard Deviation 13.01 |
| Roxadustat 0.7 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 2 Hour | -0.85 milli-international units (mIU)/mL | Standard Deviation 1.91 |
| Roxadustat 0.7 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 72 Hour | -2.85 milli-international units (mIU)/mL | Standard Deviation 5.02 |
| Roxadustat 0.7 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 24 Hour | 22.35 milli-international units (mIU)/mL | Standard Deviation 19.73 |
| Roxadustat 0.7 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 3 Hour | -0.95 milli-international units (mIU)/mL | Standard Deviation 1.34 |
| Roxadustat 0.7 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 48 Hour | 0.55 milli-international units (mIU)/mL | Standard Deviation 10.39 |
| Roxadustat 0.7 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 4 Hour | -0.45 milli-international units (mIU)/mL | Standard Deviation 0.07 |
| Roxadustat 1.0 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Day 1, Baseline | 9.00 milli-international units (mIU)/mL | — |
| Roxadustat 1.0 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 4 Hour | 29.70 milli-international units (mIU)/mL | — |
| Roxadustat 1.0 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 2 Hour | -0.60 milli-international units (mIU)/mL | — |
| Roxadustat 1.0 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 8 Hour | 462.00 milli-international units (mIU)/mL | — |
| Roxadustat 1.0 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Day 1, Baseline | 8.50 milli-international units (mIU)/mL | Standard Deviation 3.96 |
| Roxadustat 1.0 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 3 Hour | 2.30 milli-international units (mIU)/mL | — |
| Roxadustat 1.0 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 1 Hour | 0.00 milli-international units (mIU)/mL | — |
| Roxadustat 1.0 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 6 Hour | 132.80 milli-international units (mIU)/mL | — |
| Roxadustat 1.0 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 12 Hour | 492.00 milli-international units (mIU)/mL | — |
| Roxadustat 1.0 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 18 Hour | 176.90 milli-international units (mIU)/mL | — |
| Roxadustat 1.0 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 24 Hour | 33.90 milli-international units (mIU)/mL | — |
| Roxadustat 1.0 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 48 Hour | -0.50 milli-international units (mIU)/mL | — |
| Roxadustat 1.0 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 72 Hour | -1.50 milli-international units (mIU)/mL | — |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 48 Hour | -7.50 milli-international units (mIU)/mL | Standard Deviation 2.4 |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 18 Hour | 0.87 milli-international units (mIU)/mL | Standard Deviation 1.07 |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 29, 72 Hour | -1.63 milli-international units (mIU)/mL | Standard Deviation 4.71 |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 12 Hour | -1.30 milli-international units (mIU)/mL | Standard Deviation 1.71 |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 29, 2 Hour | -2.73 milli-international units (mIU)/mL | Standard Deviation 1.85 |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 8 Hour | 0.20 milli-international units (mIU)/mL | Standard Deviation 1.18 |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 29, 3 Hour | -3.70 milli-international units (mIU)/mL | Standard Deviation 2.14 |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 3 Hour | -1.27 milli-international units (mIU)/mL | Standard Deviation 3.15 |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 29, 4 Hour | -4.90 milli-international units (mIU)/mL | Standard Deviation 1.95 |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 2 Hour | 0.67 milli-international units (mIU)/mL | Standard Deviation 1.47 |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 29, 6 Hour | -4.17 milli-international units (mIU)/mL | Standard Deviation 1.27 |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Day 1, Baseline | 13.75 milli-international units (mIU)/mL | Standard Deviation 4.53 |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 29, 8 Hour | -2.97 milli-international units (mIU)/mL | Standard Deviation 2.2 |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 29, 1 Hour | -1.57 milli-international units (mIU)/mL | Standard Deviation 1.14 |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 29, 12 Hour | -2.07 milli-international units (mIU)/mL | Standard Deviation 1.08 |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 72 Hour | -0.60 milli-international units (mIU)/mL | Standard Deviation 1.27 |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 29, 18 Hour | -0.20 milli-international units (mIU)/mL | Standard Deviation 1.77 |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 6 Hour | 0.33 milli-international units (mIU)/mL | Standard Deviation 3.8 |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 29, 24 Hour | -3.07 milli-international units (mIU)/mL | Standard Deviation 0.96 |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 4 Hour | 0.50 milli-international units (mIU)/mL | Standard Deviation 4.24 |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 29, 48 Hour | -4.87 milli-international units (mIU)/mL | Standard Deviation 2.24 |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 24 Hour | 2.60 milli-international units (mIU)/mL | Standard Deviation 5.46 |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29 | Change at Day 26, 1 Hour | 0.17 milli-international units (mIU)/mL | Standard Deviation 0.21 |
Secondary
Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1
Baseline is defined as the last value obtained prior to the first dose.
Time frame: Baseline, 4, 8, 12, and 24 hours on Day 1
Population: Part 2 PK Population: Participants who received roxadustat and had sufficient plasma data to allow calculation of PK parameters. Participants with missing erythropoietin values at any timepoint were excluded from analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Roxadustat 0.7 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1 | Change at 4 Hour | 2.80 mIU/mL | Standard Deviation 3.96 |
| Roxadustat 0.7 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1 | Change at 8 Hour | 66.70 mIU/mL | Standard Deviation 90.23 |
| Roxadustat 0.7 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1 | Baseline | 8.30 mIU/mL | Standard Deviation 2.26 |
| Roxadustat 0.7 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1 | Change at 24 Hour | 10.05 mIU/mL | Standard Deviation 8.56 |
| Roxadustat 0.7 mg/kg TIW | Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1 | Change at 12 Hour | 66.25 mIU/mL | Standard Deviation 90.16 |
| Roxadustat 1.0 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1 | Change at 4 Hour | 2.10 mIU/mL | Standard Deviation 3.54 |
| Roxadustat 1.0 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1 | Baseline | 9.55 mIU/mL | Standard Deviation 3.32 |
| Roxadustat 1.0 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1 | Change at 8 Hour | 100.40 mIU/mL | Standard Deviation 92.77 |
| Roxadustat 1.0 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1 | Change at 12 Hour | 147.15 mIU/mL | Standard Deviation 128.91 |
| Roxadustat 1.0 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1 | Change at 24 Hour | 107.65 mIU/mL | Standard Deviation 53.25 |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1 | Change at 24 Hour | 461.05 mIU/mL | Standard Deviation 589.8 |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1 | Change at 12 Hour | 201.10 mIU/mL | Standard Deviation 240.42 |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1 | Change at 4 Hour | 1.00 mIU/mL | Standard Deviation 2.97 |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1 | Change at 8 Hour | 42.05 mIU/mL | Standard Deviation 36.98 |
| Roxadustat 1.5 mg/kg BIW | Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1 | Baseline | 10.45 mIU/mL | Standard Deviation 4.31 |
Secondary
Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment)
Hb response defined as an increase in Hb from baseline by ≥1.0 g/dL (not due to red blood cell transfusion or IV iron supplementation during treatment). The baseline for Hb was defined as the mean of the last 3 available Hb values obtained prior to the first dose.
Time frame: Baseline up to Day 26-29 (EoT), up to Week 8 (2 weeks of follow up), and up to Week 16 (EoS, 4 weeks of follow up)
Population: Part 1 and Part 2 EE Population: Participants who were anemic at baseline (Hb ≤11.0 g/dL) and were in study treatment for at least 2.5 weeks with corresponding Hb values.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Roxadustat 0.7 mg/kg BIW | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Week 8 | 5 Participants |
| Roxadustat 0.7 mg/kg BIW | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Week 16 | 7 Participants |
| Roxadustat 0.7 mg/kg BIW | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Day 26-29 | 1 Participants |
| Roxadustat 0.7 mg/kg TIW | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Week 8 | 7 Participants |
| Roxadustat 0.7 mg/kg TIW | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Week 16 | 7 Participants |
| Roxadustat 0.7 mg/kg TIW | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Day 26-29 | 6 Participants |
| Roxadustat 1.0 mg/kg BIW | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Week 8 | 3 Participants |
| Roxadustat 1.0 mg/kg BIW | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Week 16 | 3 Participants |
| Roxadustat 1.0 mg/kg BIW | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Day 26-29 | 1 Participants |
| Roxadustat 1.0 mg/kg TIW | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Day 26-29 | 1 Participants |
| Roxadustat 1.0 mg/kg TIW | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Week 8 | 2 Participants |
| Roxadustat 1.0 mg/kg TIW | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Week 16 | 2 Participants |
| Roxadustat 1.5 mg/kg BIW | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Week 16 | 9 Participants |
| Roxadustat 1.5 mg/kg BIW | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Day 26-29 | 8 Participants |
| Roxadustat 1.5 mg/kg BIW | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Week 8 | 8 Participants |
| Roxadustat 1.5 mg/kg TIW | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Week 16 | 10 Participants |
| Roxadustat 1.5 mg/kg TIW | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Week 8 | 10 Participants |
| Roxadustat 1.5 mg/kg TIW | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Day 26-29 | 10 Participants |
| Roxadustat 2.0 mg/kg BIW | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Week 16 | 9 Participants |
| Roxadustat 2.0 mg/kg BIW | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Week 8 | 9 Participants |
| Roxadustat 2.0 mg/kg BIW | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Day 26-29 | 7 Participants |
| Roxadustat 2.0 mg/kg TIW | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Day 26-29 | 9 Participants |
| Roxadustat 2.0 mg/kg TIW | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Week 8 | 11 Participants |
| Roxadustat 2.0 mg/kg TIW | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Week 16 | 11 Participants |
| Placebo | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Day 26-29 | 3 Participants |
| Placebo | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Week 8 | 6 Participants |
| Placebo | Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment) | Week 16 | 8 Participants |
Secondary
Plasma Roxadustat Concentration (Part 2)
Time frame: Predose on Days 3 (TIW dose groups) or 4 (BIW dose groups), 8, 15, 22, and 26 (TIW dose groups) or 29 (BIW dose groups)
Population: Part 2 PK Population: Participants who received roxadustat and had sufficient plasma data to allow calculation of PK parameters. Participants in the roxadustat groups were evaluated. 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 |
|---|---|---|---|---|
| Roxadustat 0.7 mg/kg BIW | Plasma Roxadustat Concentration (Part 2) | Day 4 | 28.596 nanograms (ng)/milliliter (mL) | Standard Deviation 19.737 |
| Roxadustat 0.7 mg/kg BIW | Plasma Roxadustat Concentration (Part 2) | Day 22 | 36.432 nanograms (ng)/milliliter (mL) | Standard Deviation 33.587 |
| Roxadustat 0.7 mg/kg BIW | Plasma Roxadustat Concentration (Part 2) | Day 15 | 22.997 nanograms (ng)/milliliter (mL) | Standard Deviation 18.442 |
| Roxadustat 0.7 mg/kg BIW | Plasma Roxadustat Concentration (Part 2) | Day 29 | 14.332 nanograms (ng)/milliliter (mL) | Standard Deviation 9.935 |
| Roxadustat 0.7 mg/kg BIW | Plasma Roxadustat Concentration (Part 2) | Day 8 | 19.884 nanograms (ng)/milliliter (mL) | Standard Deviation 18.858 |
| Roxadustat 0.7 mg/kg TIW | Plasma Roxadustat Concentration (Part 2) | Day 3 | 394.800 nanograms (ng)/milliliter (mL) | Standard Deviation 723.156 |
| Roxadustat 0.7 mg/kg TIW | Plasma Roxadustat Concentration (Part 2) | Day 8 | 203.535 nanograms (ng)/milliliter (mL) | Standard Deviation 343.167 |
| Roxadustat 0.7 mg/kg TIW | Plasma Roxadustat Concentration (Part 2) | Day 15 | 195.483 nanograms (ng)/milliliter (mL) | Standard Deviation 369.794 |
| Roxadustat 0.7 mg/kg TIW | Plasma Roxadustat Concentration (Part 2) | Day 22 | 153.903 nanograms (ng)/milliliter (mL) | Standard Deviation 173.388 |
| Roxadustat 0.7 mg/kg TIW | Plasma Roxadustat Concentration (Part 2) | Day 26 | 331.640 nanograms (ng)/milliliter (mL) | Standard Deviation 435.773 |
| Roxadustat 1.0 mg/kg BIW | Plasma Roxadustat Concentration (Part 2) | Day 4 | 168.310 nanograms (ng)/milliliter (mL) | Standard Deviation 174.426 |
| Roxadustat 1.0 mg/kg BIW | Plasma Roxadustat Concentration (Part 2) | Day 15 | 134.116 nanograms (ng)/milliliter (mL) | Standard Deviation 269.89 |
| Roxadustat 1.0 mg/kg BIW | Plasma Roxadustat Concentration (Part 2) | Day 22 | 147.323 nanograms (ng)/milliliter (mL) | Standard Deviation 235.302 |
| Roxadustat 1.0 mg/kg BIW | Plasma Roxadustat Concentration (Part 2) | Day 8 | 125.185 nanograms (ng)/milliliter (mL) | Standard Deviation 223.124 |
| Roxadustat 1.0 mg/kg BIW | Plasma Roxadustat Concentration (Part 2) | Day 29 | 150.599 nanograms (ng)/milliliter (mL) | Standard Deviation 233.871 |
| Roxadustat 1.0 mg/kg TIW | Plasma Roxadustat Concentration (Part 2) | Day 3 | 260.027 nanograms (ng)/milliliter (mL) | Standard Deviation 133.524 |
| Roxadustat 1.0 mg/kg TIW | Plasma Roxadustat Concentration (Part 2) | Day 8 | 168.955 nanograms (ng)/milliliter (mL) | Standard Deviation 147.019 |
| Roxadustat 1.0 mg/kg TIW | Plasma Roxadustat Concentration (Part 2) | Day 26 | 223.140 nanograms (ng)/milliliter (mL) | Standard Deviation 140.34 |
| Roxadustat 1.0 mg/kg TIW | Plasma Roxadustat Concentration (Part 2) | Day 15 | 247.945 nanograms (ng)/milliliter (mL) | Standard Deviation 204.624 |
| Roxadustat 1.0 mg/kg TIW | Plasma Roxadustat Concentration (Part 2) | Day 22 | 163.100 nanograms (ng)/milliliter (mL) | Standard Deviation 167.695 |
| Roxadustat 1.5 mg/kg BIW | Plasma Roxadustat Concentration (Part 2) | Day 29 | 193.622 nanograms (ng)/milliliter (mL) | Standard Deviation 279.533 |
| Roxadustat 1.5 mg/kg BIW | Plasma Roxadustat Concentration (Part 2) | Day 8 | 291.856 nanograms (ng)/milliliter (mL) | Standard Deviation 376.91 |
| Roxadustat 1.5 mg/kg BIW | Plasma Roxadustat Concentration (Part 2) | Day 4 | 283.067 nanograms (ng)/milliliter (mL) | Standard Deviation 376.601 |
| Roxadustat 1.5 mg/kg BIW | Plasma Roxadustat Concentration (Part 2) | Day 22 | 171.833 nanograms (ng)/milliliter (mL) | Standard Deviation 138.575 |
| Roxadustat 1.5 mg/kg BIW | Plasma Roxadustat Concentration (Part 2) | Day 15 | 358.400 nanograms (ng)/milliliter (mL) | Standard Deviation 491.898 |
| Roxadustat 1.5 mg/kg TIW | Plasma Roxadustat Concentration (Part 2) | Day 15 | 175.570 nanograms (ng)/milliliter (mL) | Standard Deviation 144.779 |
| Roxadustat 1.5 mg/kg TIW | Plasma Roxadustat Concentration (Part 2) | Day 26 | 508.889 nanograms (ng)/milliliter (mL) | Standard Deviation 295.228 |
| Roxadustat 1.5 mg/kg TIW | Plasma Roxadustat Concentration (Part 2) | Day 8 | 297.500 nanograms (ng)/milliliter (mL) | Standard Deviation 393.134 |
| Roxadustat 1.5 mg/kg TIW | Plasma Roxadustat Concentration (Part 2) | Day 22 | 239.600 nanograms (ng)/milliliter (mL) | Standard Deviation 324.307 |
| Roxadustat 1.5 mg/kg TIW | Plasma Roxadustat Concentration (Part 2) | Day 3 | 422.700 nanograms (ng)/milliliter (mL) | Standard Deviation 148.529 |