Comparative Study of the Efficacy and Safety of BCD-131 and Mircera in Treatment of Anemia in CKD Patients on Dialysis
Condition: Anemia
MeSH terms: Anemia
Intervention: BCD-131; Mircera
Intervention description: subcutaneously monthly; subcutaneously monthly
Intervention MeSH terms: Darbepoetin alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      BCD-131 is pegylated darbepoetin beta. BCD-131-2 is International Multicenter Randomized
      Open-Label Comparative Study (Phase II) of the Efficacy and Safety of BCD-131 and Mircera in
      Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed written informed consent.

          -  Men and women aged from 18 to 75 years (inclusive) on the day of signing informed
             consent;

          -  End-stage kidney disease.

          -  Need for dialysis for at least 3 months before signing informed consent.

          -  Need for at least 12 hours on standard dialysis procedure weekly.

          -  rHuEpo (epoetin alpha, epoetin beta, darbepoetin alpha) administration for at least 3
             months before signing informed consent.

          -  Regular rHuEpo (epoetin alfa, epoetin beta, darbepoetin alfa) administration 1, 2 or 3
             times a week (stable dose, stable frequency) before signing informed consent.

          -  Target hemoglobin level (100-120 g/l) for at least 3 months before signing informed
             consent.

          -  Effective dialysis dose index (Kt/v) ≥1.2 for patients receiving hemodialysis and
             (Kt/v) ≥1.7 for patients receiving peritoneal dialysis.

          -  TSAT ≥20%, Serum ferritin >200 ng/ml.

          -  Patients and their sexual partners with childbearing potential must implement reliable
             contraceptive measures during all the study treatment, starting 4 weeks prior to the
             administration of the first dose of investigational product until 4 weeks after the
             last dose of investigational product. This requirement does not apply to participants
             who have undergone surgical sterilization. Reliable contraceptive measures include two
             methods of contraception, including one barrier method/

          -  Patients should be able to follow the Protocol procedures

        Exclusion Criteria:

          -  Any other causes of anemia except for renal anemia, including folate and B12
             deficiency, chronic blood loss, aluminium intoxication, sickle-cell anemia, chronic
             disease anemia (CRP above 20 mg/l), refractory anemia with blast cells in peripheral
             blood.

          -  Lupus nephritis of kidney disease due to systemic vasculitis.

          -  Platelet count below 100х10^9 cells/l.

          -  Scheduled kidney transplant during study participation period.

          -  Hypersensitivity to darbepoetin alfa or of any components of study drugs, or to Fe
             (III)-hydroxide-sucrose complex.

          -  Vaccination less than 8 weeks before signing informed consent.

          -  Liver cirrhosis with portal hypertension and/or splenomegaly and/or ascitis.

          -  HIV infection, active HBV, HCV.

          -  ALT, AST level above 3x ULN.

          -  Congestive heart failure (Grade IV NYHA)

          -  Resistant arterial hypertension.

          -  Unstable angina.

          -  Hemoglobinopathy, MDS, hematologic malignancy, PRCA.

          -  Severe secondary hyperparathyroidism.

          -  Gastrointestinal bleeding history.

          -  Thrombotic events history (myocardial infarction, stroke, TIA, DVT, PATE) less than 6
             months before signing informed consent.

          -  Seizures, including epilepsy.

          -  Major surgery in less than 1 month before signing informed consent

          -  Blood transfusions in less than 3 months before signing informed consent.

          -  Acute inflammatory diseases or exacerbations of chronic inflammation.

          -  Severe psychiatric disorders and suicidal ideation and suicidal behavior.

          -  History of malignancy, excluding appropriately treated basal cell carcinoma or
             cervical carcinoma in situ.

          -  Alcohol or drug abuse.

          -  Simultaneous participation in other trials or in less than 3 months before signing
             informed consent

          -  Pregnancy of breast-feeding.