CLINI CAL TRIALS

BCD-066-2
STATUS: SETTING

A Multicenter, Double-blind, Randomized, Parallel, Comparative Study of Efficacy and Safety of BCD-066 (CJSC BIOCAD, Russia) and Aranesp® (Amgen Europe B.V., Netherlands) in the Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis.

Inclusion Criteria

  • Written Informed Consent.
  • Age from 18 to 75 years old, both inclusive.
  • End-stage kidney disease.
  • Need for dialysis for at least 3 months before enrollment (randomization).
  • Need for at least 12 hours of standard dialysis per week.
  • Regular administration of recombinant human erythropoietin (rHuEpo) 1, 2 or 3 times a week (stable dose, stable frequency) for at least 3 months before enrollment (randomization).
  • Target hemoglobin level (100-120 g/l) for at least 3 months before enrollment (randomization).
  • Effective dialysis (Kt/v) ≥1.2).
  • Transferrin saturation (TSAT) ≥ 20%; serum ferritin >100 ng/ml.
  • Patients and their sexual partners of childbearing potential should agree to implement highly effective contraception methods starting from the screening and until 4 weeks after the last dose of the study product. This requirement does not apply to participants who have undergone surgical sterilization. Reliable contraceptive measures include two separate methods of contraception, one of which is required to be an effective barrier contraceptive method, and another one can be either spermicidal agent or oral contraceptive.
  • 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, aluminum intoxication, sickle-cell anemia, chronic disease anemia (CRP > 10 mg/l), refractory anemia with blast cells in peripheral blood.
  • Lupus nephritis of kidney disease due to systemic vasculitis.
  • Platelet count <100х109/l.
  • Hemoglobin <100 g/l or >120 g/l.
  • Kidney transplant scheduled within the assumed period of study participation.
  • Binding/neutralizing antibodies against erythropoietin/darbepoetin.
  • History of severe allergic reactions (anaphylactic collapse or multiple drug allergies).
  • Vaccination in less than 8 weeks before randomization.
  • Liver cirrhosis with portal hypertension and/or splenomegaly and/or ascitis.
  • HIV infection, active HBV or HCV.
  • ALT or AST levels >3хULN.
  • Documented bone marrow fibrosis.
  • Congestive heart failure (NYHA grade IV).
  • Resistant arterial hypertension.
  • Unstable angina.
  • Hemoglobinopathies, MDS, or malignant tumors involving hematopoietic and lymphoid tissues.
  • PRCA.
  • Severe secondary hyperparathyroidism (PTH > 9xULN).
  • History of GI hemorrhages.
  • History of thrombotic events (myocardial infarction, stroke, TIA, DVT, PATE) within 6 months before inclusion in the active study phase; high risk of DVT.
  • History of acute hemolysis.
  • Seizures, including epilepsy.
  • Major surgery within 1 month before randomization.
  • Blood transfusion within 3 months before randomization.
  • Any acute inflammatory diseases or exacerbation of chronic inflammatory diseases including septic foci or aseptic inflammation foci (hematomas).
  • Any psychiatric disorders including a history of severe depressive disorders and/or suicidal thoughts/attempts, which, in investigator's opinion, can affect patient's ability to follow the study Protocol (including partially impaired patients).
  • History of malignant tumors, except for appropriately treated basal carcinoma and/or cervical cancer in situ.
  • Alcohol or drug abuse.
  • Hypersensitivity to darbepoetin alfa or any other components of study medications.
  • Hypersensitivity to iron(III)-hydroxide sucrose complex.
  • Simultaneous participation in other clinical studies or previous participation in other clinical studies within 3 months from enrollment to the present trial.
  • Pregnancy and lactation.