NCT07119372View on ClinicalTrials.gov

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

PHASE3RecruitingINTERVENTIONAL
Enrollment

228

Participants

Timeline

Start Date

March 1, 2025

Primary Completion Date

May 31, 2026

Study Completion Date

November 30, 2026

Conditions
AnemiaChronic Kidney DiseaseChronic Kidney Disease Patients on HemodialysisChronic Kidney Disease 5D
Interventions
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

Trial Locations (2)

199004

RECRUITING

B. Braun Avitum Russland Clinics Ltd., Saint Petersburg

220045

RECRUITING

Minsk Scientific and Practical Center for Surgery, Transplantology and Hematology, Minsk

Sponsors

Lead Sponsor

Biocad
All Listed Sponsors
lead

Biocad

INDUSTRY

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 | Biotech Hunter | Biotech Hunter