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

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 \<100×10\^9/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.

What this study is about