RecruitingPhase 3NCT07119372

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


Sponsor

Biocad

Enrollment

228 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two medications used to treat anemia in patients with end-stage kidney disease who are on dialysis. It compares BCD-131 (a biosimilar drug) against Mircera (a well-established anemia treatment), both of which stimulate the body to make more red blood cells. The goal is to show that BCD-131 is just as effective and safe as Mircera. **You may be eligible if...** - You are aged 18–75 with documented end-stage kidney disease - You have been on dialysis for at least 90 days (hemodialysis at least 3 times a week, or peritoneal dialysis) - You have been using a specific form of erythropoietin (epoetin alfa or similar) as your current anemia treatment - You have stable hemoglobin levels within the required range **You may NOT be eligible if...** - You have not been on dialysis for at least 90 days - You are not currently on an erythropoiesis-stimulating agent - You are pregnant or breastfeeding - You have uncontrolled hypertension or recent cardiovascular events Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALBCD-131 (pegdarbepoetin beta)

BCD-131 (pegdarbepoetin beta), subcutaneous injection; regimen: once every 4 weeks; therapy duration: 52 weeks

BIOLOGICALMircera (methoxypolyethylene glycol-epoetin beta)

Mircera (methoxypolyethylene glycol-epoetin beta), subcutaneous injection; regimen: once every 4 weeks; therapy duration: 52 weeks


Locations(2)

Minsk Scientific and Practical Center for Surgery, Transplantology and Hematology

Minsk, Belarus

B. Braun Avitum Russland Clinics Ltd.

Saint Petersburg, Russia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07119372


Related Trials