Actively Recruiting
A Randomized, Open-label, Comparative Study of the Efficacy and Safety of BCD-131 and Mircera in Treating Anemia in Chronic Kidney Disease Patients on Dialysis
Led by Biocad · Updated on 2025-08-13
228
Participants Needed
2
Research Sites
26 weeks
Total Duration
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AI-Summary
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 g/L, 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.
CONDITIONS
Brief Title
Study of the Efficacy and Safety of BCD-131 and Mircera® in the Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient signed a written informed consent form.
- Men and women aged 18 to 75 years inclusive.
- Documented end-stage kidney disease.
- Receiving dialysis sessions for at least 90 days prior to consent.
- For hemodialysis patients, at least 3 sessions per week totaling 12 hours per week.
- Use of recombinant erythropoietin for at least 90 days prior to consent.
- Stable dose of recombinant erythropoietins for at least 90 days prior to consent and during screening.
- Target hemoglobin level between 100-120 g/L based on two screening measurements.
- Established dialysis efficacy at screening (Kt/v ≥1.2 for hemodialysis, ≥1.7 for peritoneal dialysis).
- Transferrin saturation ≥20% and ferritin level >100 ng/mL at screening.
- Vitamin B12 and folic acid levels within normal lab reference values at screening.
- Willingness to use contraception during and up to 90 days after the study.
- Ability to comply with study protocol requirements as judged by investigator.
You will not qualify if you...
- Any anemia causes other than renal origin, including anemia of chronic disease (CRP >20 mg/L).
- Diagnosed lupus nephritis or CKD due to systemic vasculitis.
- Platelet count less than 100 x 10^9/L at screening.
- Planned kidney transplant surgery during study participation.
- History of severe allergic reactions or hypersensitivity to study drugs or components.
- Vaccination less than 8 weeks before consent.
- Diagnosed liver cirrhosis.
- HIV infection.
- ALT or AST greater than three times the upper limit of normal.
- Decompensated heart disease (NYHA Class IV CHF).
- Resistant hypertension or unstable angina.
- History of acute hemolysis.
- Hemoglobinopathy, myelodysplastic syndrome, hematological malignancy, or pure red cell aplasia.
- Severe secondary hyperparathyroidism or bone marrow fibrosis.
- Gastrointestinal or other bleeding episodes within 90 days prior to consent.
- Thrombosis episodes within 6 months or vascular access thrombosis within 30 days prior to consent.
- Seizure syndrome or epilepsy during screening.
- Major surgery less than 30 days before consent.
- Blood transfusion within 90 days prior to consent.
- Acute or exacerbated chronic infections or other diseases affecting safety.
- History of severe depression, suicidal ideation, or attempts.
- Malignancies except cured basal-cell carcinoma or cervical carcinoma in situ with remission over 5 years.
- Known or current alcohol or drug addiction affecting treatment adherence.
- Participation in other drug clinical trials within 90 days prior to consent.
- Pregnancy or breastfeeding.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 28 days
Participants are screened for eligibility to participate in the trial.
Multiple visits during screening period
Duration - 52 weeks
Participants receive subcutaneous injections of either BCD-131 or Mircera once every 4 weeks as maintenance therapy for anemia related to chronic kidney disease on dialysis.
Monthly visits for injections and assessments
Duration - 4 weeks
Participants are monitored for safety and efficacy outcomes after treatment completion.
1 follow-up visit
Trial Site Locations
Total: 2 locations
1
Minsk Scientific and Practical Center for Surgery, Transplantology and Hematology
Minsk, Belarus, 220045
Actively Recruiting
2
B. Braun Avitum Russland Clinics Ltd.
Saint Petersburg, Russia, 199004
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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