Desidustat in the Treatment of Anemia in CKD (NCT04012957) | Clinical Trial Compass
CompletedPhase 3
Desidustat in the Treatment of Anemia in CKD
India588 participantsStarted 2019-07-20
Plain-language summary
This is a phase III, multicenter, multi-country, open-label, randomized, active-controlled clinical trial to evaluate the efficacy and safety of Desidustat versus Darbepoetin for the treatment of anemia in patients with CKD who are not on dialysis. The study will be conducted over a period of up to 30 weeks.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Current clinical diagnosis of anemia due to CKD, baseline hemoglobin concentrations must be 7.0-10.0 g/dL (both inclusive) before the enrollment.
✓. Ability to understand and give informed consent for participation.
✓. Male or female patients diagnosed with CKD (stage III to V, not receiving dialysis) defined by estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.
✓. Male or female, 18 to 80 years of age.
✓. Body weight \> 40 kg.
✓. Subjects not on dialysis and not expected to start dialysis during the study period.
✓. Patients must not be treated with erythropoiesis-stimulating agent (ESA) therapy within 6 weeks prior to enrollment.
✓. Estimated GFR ≥10 mL/min/1.73 m2.
Exclusion criteria
✕. Prior chronic hemodialysis or chronic peritoneal dialysis treatment.
✕. Intravenous iron within 14 days prior to enrollment.
✕. Prior exposure of rhEPO analogues less than 04 weeks.
✕. Red blood cell transfusion within 8 weeks prior to enrollment.