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

Launched by BIOCAD · Aug 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medicine called BCD-131 compared to another drug called Mircera® for treating anemia in people with advanced chronic kidney disease who are on dialysis. Anemia is a condition where the body doesn’t have enough healthy red blood cells, which can cause tiredness and weakness. Both medicines aim to help the body make more red blood cells to improve symptoms and quality of life.

People who might be eligible to join this study are adults aged 18 to 75 who have end-stage kidney disease and have been receiving regular dialysis treatments (at least three times a week for hemodialysis) for at least three months. Participants should already be using certain anemia medicines and have stable treatment before joining. The study will carefully check each person’s health to make sure they meet all the requirements and don’t have other conditions that could affect safety. Those who join will receive one of the two medicines and will be monitored closely to see how well the treatment works and if there are any side effects. It’s important for participants to be willing to follow the study rules, including using birth control during and shortly after the trial if needed. This trial is currently recruiting patients who fit these criteria.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • The patient signed a written ICF for participation in the study.
• • Men and women aged 18 to 75 years inclusive at the time of signing the ICF.
• • End stage kidney disease (documented).
• • The need for dialysis sessions within at least the last 90 days prior to signing the ICF.
• • For patients on hemodialysis - hemodialysis procedures should be at least 3 times a week, for a total duration of at least 12 hours a week.
• • Documented use of recombinant erythropoietin (epoetin alfa, epoetin beta or darbepoetin alfa) for at least 90 days prior to signing the ICF.
• • The dose of recombinant erythropoietins (epoetin alfa or epoetin beta received 1, 2 or 3 times a week, or darbepoetin alfa received once a week/once every 2 weeks) should be stable for at least 90 days prior to signing the ICF and the entire screening period (documented).
• • Target hemoglobin level (100-120 g/L inclusive) based on the results of screening examination (two measurements).
• • The efficacy of dialysis established at screening or not more than 14 days before signing the ICF (dialysis dose index (Kt/v) ≥1.2 in patients on long-term hemodialysis, and weekly Kt/v ≥1.7 for patients on peritoneal dialysis).
• • Transferrin saturation ≥20%, ferritin level \>100 ng/mL at screening.
• • Cyancobalamine (vitamin B12) and folic acid levels within the laboratory reference values at screening.
• • Willingness of patients of both sexes and their sexual partners of childbearing potential to use methods of contraception in accordance with the protocol, starting from signing the informed consent form, throughout the study and for up to 90 days after receiving the last dose of the drug in the clinical study, as well as to refrain from donation of eggs for female subjects or sperm for male subjects during this period.
• • The ability of the patient to comply with the Protocol requirements, in the Investigator's opinion.
• Exclusion Criteria:
• • Any other diagnosed forms of anemia, except for anemia of renal disease, including anemia in chronic diseases (C-reactive protein level \>20 mg/L at screening).
• • Diagnosed lupus nephritis or chronic kidney disease due to systemic vasculitis.
• • Platelet count \<100×109/L based on the results of screening examination.
• • A high probability of early withdrawal from the study, in particular a planned (i.e., available information about a planned date and/or a suitable donor) kidney transplant surgery during the estimated period of participation in the study.
• • A history of severe allergic reactions (anaphylactic shock or multiple drug allergy) according to the patient, and hypersensitivity to recombinant erythropoietins, polyethylene glycol or any components of the study drugs, or to iron (III) hydroxide sucrose complex.
• • Vaccination less than 8 weeks before signing the ICF (according to the patient).
• • Diagnosed liver cirrhosis.
• • HIV infection.
• • ALT, AST \>3хULN at screening.
• • Decompensated heart disease (NYHA Class IV CHF).
• • Resistant hypertension.
• • Unstable angina.
• • History of acute hemolysis episodes.
• • Documented hemoglobinopathy, myelodysplastic syndrome, hematological malignancy, pure red cell aplasia.
• • Severe secondary hyperparathyroidism (intact PTH\>1000 pg/mL at screening) or biopsy-confirmed bone marrow fibrosis (myelofibrosis).
• • Documented episodes of gastrointestinal or other bleeding within less than 90 days prior to signing the ICF.
• • Documented history of episodes of thrombosis (acute myocardial infarction, stroke, transient ischemic attacks, deep vein thrombosis, pulmonary thromboembolism within less than 6 months before the signing of the ICF, as well as long-term vascular access thrombosis within 30 days before the signing of the ICF.
• • Seizure syndrome, including a history of or epilepsy during the screening period.
• • Documented major surgery less than 30 days before signing the ICF.
• • Documented blood transfusion within less than 90 days prior to signing the ICF.
• • Any acute or chronic infections in the stage of exacerbation, as well as other chronic diseases that at the time of signing the informed consent, may adversely affect the patient's safety while using the study therapy in the opinion of the investigator.
• • A history of severe depression, suicidal ideation, or attempted suicide.
• • Documented malignancies other than cured basal-cell carcinoma and/or cervical carcinoma in situ with a remission duration of more than 5 years at the time of signing the ICF.
• • Known alcohol or drug addiction, or current signs of alcohol/drug addiction, which, according to the investigator, is contraindication for the treatment with the test drug/reference drug or limits the treatment adherence.
• • Participation in other clinical studies of medicinal products within less than 90 calendar days prior to signing the informed consent form for participation in this study.
• • Pregnancy or breastfeeding.