Safety and Efficacy Study of BCD-066 Compared to Aranesp® for Anemia Treatment in Chronic Kidney Disease Patients
Condition: Chronic Kidney Disease; End Stage Renal Failure on Dialysis; Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Anemia
Intervention: Darbepoetin alfa
Intervention description: Weekly sc administration of darbepoetin alfa
Intervention MeSH terms: Darbepoetin alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 196.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: darbepoetin alfa

Summary:

      The purpose of the study is to prove equivalence of efficacy and safety of BCD-066 and
      Aranesp® in treatment of anemia in end-stage chronic kidney disease patients on dialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  Age between 18 and 75 years

          -  End-stage kidney disease

          -  Need for dialysis for at least 3 months before enrollment

          -  Need for at least 12 hours on standard dialysis procedure weekly

          -  Regular rHuEpo (epoetin alfa, epoetin beta, darbepoetin alfa) administration 1, 2 or 3
             times a week (stable dose, stable frequency) for at least 3 months before enrollment

          -  Target hemoglobin level (100-120 g/l) for at least 3 months before enrollment

          -  Effective dialysis (Kt/v≥1,2)

          -  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 (according to Investigator's
             assessment)

        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

          -  Hemoglobin above 120 g/l or below 100 g/l

          -  Scheduled kidney transplant during study participation period

          -  Binding/neutralizing antibodies against erythropoetin/darbepoetin

          -  History of severe allergic reactions

          -  Vaccination less than 8 weeks before enrollment

          -  Liver cirrhosis with portal hypertension and/or splenomegaly and/or ascitis

          -  HIV infection, active HBV, HCV

          -  ALT, AST level above 3x ULN

          -  Bone marrow fibrosis

          -  Congestive heart failure (Grade IV NYHA)

          -  Resistant arterial hypertension

          -  Unstable angina

          -  Hemoglobinopathy, MDS, hematologic malignancy

          -  PRCA

          -  Severe secondary hyperparathyroidism (PTH > 9x ULN)

          -  GI bleeding history

          -  Thrombotic events history (myocardial infarction, stroke, TIA, DVT, PATE) less than 6
             months before enrollment

          -  Acute hemolysis history

          -  Seizures, including epilepsy

          -  Major surgery in less than 1 month before enrollment

          -  Blood transfusions in less than 3 months before enrollment

          -  Acute inflammatory diseases or exacerbations of chronic inflammation including septic
             of aseptic inflammation foci

          -  Severe psychiatric disorders

          -  History of malignancy, excluding appropriately treated basal cell carcinoma or
             cervical carcinoma in situ

          -  Alcohol or drug abuse

          -  Hypersensitivity to darbepoetin alfa of any components of study drugs

          -  Simultaneous participation in other trials or in less than 3 months before enrollment

          -  Pregnancy of breast-feeding