Phase III Study Comparing BCD-131 and Mircera to Treat Anemia in Adults with End-Stage Chronic Kidney Disease on Dialysis

What this Trial Is About

Researchers are evaluating the efficacy and safety of BCD-131, a pegylated darbepoetin beta, compared to Mircera in treating anemia in patients with end-stage chronic kidney disease CKD who are on dialysis. This phase III, randomized, open-label trial focuses on patients who have been on dialysis for at least 90 days and have anemia due to kidney disease, excluding other causes of anemia. The study aims to demonstrate that BCD-131 is not inferior to Mircera after 32 weeks of treatment. Participants will receive either BCD-131 or Mircera, both given as subcutaneous injections once every four weeks for a total of 52 weeks. The study includes a 28-day screening period, a main treatment period of 32 weeks divided into dose titration and maintenance phases, followed by a 20-week extension period to assess long-term safety and efficacy, and a 4-week follow-up period. The treatment is administered regularly, and dosing adjustments may be made based on response. During the study, participants will undergo regular assessments including hemoglobin level measurements to maintain target levels between 100-120 gL, dialysis efficacy checks, and safety monitoring for adverse events. Researchers will track the proportion of subjects achieving target hemoglobin levels, dose adjustments, blood transfusions, and any side effects related to the treatments. The total participation lasts about 56 weeks, with ongoing evaluation throughout the different study periods.

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