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

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 contra…