A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis
CKD Anemia
About this trial
This is an interventional treatment trial for CKD Anemia focused on measuring anemia, chronic kidney disease (CKD), non-dialysis, Hemoglobin (Hb), End-Stage Renal Disease, erythropoeitin, ASP1517, erythropoeisis stimulating-agent, AZD9941
Eligibility Criteria
Inclusion Criteria:
- Chronic kidney disease Stages 3, 4, or 5 and not receiving dialysis
- Anemia qualified by measurements of hemoglobin values during screening
- Additional blood work must be in a safe range for study entry
- Body weight 45 to 160 kilograms (kg)
- Willingness to use contraception if of child-bearing potential
Exclusion Criteria:
- Treatment with an erythropoiesis-stimulating agent (ESA) within 12 weeks prior to study participation
- More than 1 dose of intravenous iron within 12 weeks prior to study participation
- Blood transfusion within 8 weeks prior to study participation
- Active infection
- Chronic liver disease
- Severe congestive heart failure, recent heart attack, stroke, seizure, or blood clot
- Uncontrolled blood pressure within 2 weeks prior to study participation
- Renal cell carcinoma
- History of malignancy, including multiple myeloma or other myelodysplastic syndrome
- Chronic inflammatory disease that could impact red blood cell production
- Any prior organ transplant or a scheduled organ transplantation
- Anticipated elective surgery that is expected to lead to significant blood loss or anticipated elective heart procedure
- Gastrointestinal bleeding
- Any prior treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI)
- Recent use of an investigational drug or treatment, or participation in an investigational study
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Roxadustat
Placebo
Participants will receive roxadustat tablets orally 3 times a week (TIW). The initial dose will be according to the tiered weight-based approach, with starting roxadustat doses of 70 milligrams (mg) TIW to participants weighing <70 kilograms (kg) and roxadustat doses of 100 mg TIW to participants weighing ≥70 kg. Dose-titration (up to a maximum dose of 300 mg) will be performed based upon regular measurement of Hb levels until the participant achieves central Hb value of ≥11.0 grams/deciliter (g/dL) and Hb increase from baseline (BL) of ≥1.0 g/dL at 2 consecutive study visits, separated by at least 5 days. Once target Hb level is reached, the participant will enter the maintenance period during which roxadustat dosage will be adjusted every 4 weeks to maintain participant's Hb level within the target range of 10.0 g/dL and 12.0 g/dL. The maximum treatment duration will be up to 234.9 weeks.
Participants will receive roxadustat-matching placebo tablets orally TIW. The initial dose will be according to the tiered weight-based approach, with starting roxadustat-matching placebo doses of 70 mg TIW to participants weighing <70 kg and roxadustat-matching placebo doses of 100 mg TIW to participants weighing ≥70 kg. Dose-titration (up to a maximum dose of 300 mg) will be performed based upon regular measurement of Hb levels until the participant achieves central Hb value of ≥11.0 g/dL and Hb increase from BL of ≥1.0 g/dL at 2 consecutive study visits, separated by at least 5 days. Once target Hb level is reached, the participant will enter the maintenance period during which roxadustat dosage will be adjusted every 4 weeks to maintain participant's Hb level within the target range of 10.0 g/dL and 12.0 g/dL. The maximum treatment duration will be up to 208.1 weeks.