NCT07119372

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

A Randomized, Open-label, Comparative Clinical Study of the Efficacy and Safety of BCD-131 and Mircera® in the Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: Biocad · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This clinical study is based on the hypothesis that BCD-131 is non-inferior to Mircera when used for the treatment of anemia in dialysis patients with end-stage CKD after 32 weeks of therapy. The study is intended to include subjects with stage 5 CKD, receiving dialysis for at least 90 days before signing the ICF (for patients on hemodialysis - a least 3 times per week and at least 12 hours per week of standard hemodialysis), with established dialysis efficacy, with anemia of renal origin, without other causes for anemia (anemia of chronic disease, vitamin B12 deficiency, folic acid deficiency, iron deficiency, etc.). This is a study of efficacy of BCD-131 as a maintenance therapy, therefore the population includes patients who have been receiving stable doses of erythropoietins (epoetin alfa, epoetin beta or darbepoetin alfa) for at least 3 months prior to signing the informed consent form (ICF) and throughout the screening period and with target hemoglobin level (100-120 g/L) maintained for at least 2 weeks before the ICF signing and at the screening. The study includes the following periods: * Screening period (28 days), * Main period (32 weeks), consisting of dose titration (weeks 0-12) and maintenance therapy (weeks 13-32) - for the primary efficacy analysis * Extension period (weeks 33-52) - for long-term safety and efficacy assessment * Follow-up period (weeks 53-56)

Conditions

• Anemia
• Chronic Kidney Disease
• Chronic Kidney Disease Patients on Hemodialysis
• Chronic Kidney Disease 5D

Interventions

Type	Name	Description
BIOLOGICAL	BCD-131 (pegdarbepoetin beta)	BCD-131 (pegdarbepoetin beta), subcutaneous injection; regimen: once every 4 weeks; therapy duration: 52 weeks
BIOLOGICAL	Mircera (methoxypolyethylene glycol-epoetin beta)	Mircera (methoxypolyethylene glycol-epoetin beta), subcutaneous injection; regimen: once every 4 weeks; therapy duration: 52 weeks

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-05-01
• Completion: 2026-11-01
• First posted: 2025-08-13
• Last updated: 2025-08-13

Locations

2 sites across 2 countries: Belarus, Russia