Clinical Trial

Study of the Efficacy and Safety of BCD-131 and Mircera® in the Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis

Recruiting Phase 3
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Record status
This record was last updated August 13, 2025 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.
Summary
BCD-131 is pegylated darbepoetin beta. This clinical study BCD-131-3 is a randomized, open-label, phase III study of the efficacy and safety of BCD-131 and Mircera used for the treatment of anemia in end-stage chronic kidney disease (CKD) patients on dialysis.
Trial Details
NCT Number NCT07119372
Lead Sponsor Biocad
Conditions Anemia, Chronic Kidney Disease, Chronic Kidney Disease Patients on Hemodialysis, Chronic Kidney Disease 5D
Enrollment 228 participants
Start Date 2025-03-01
Primary Completion 2026-05 (estimated)
Study Completion 2026-11 (estimated)
Updated on ClinicalTrials.gov 2025-08-13