• 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.