CLINI CAL TRIALS

BCD-109-1
STATUS: COMING SOON

A multicenter, open-label, randomized clinical study of the efficacy and safety of BCD-109 (CJSC BIOCAD, Russia) versus Venofer® (Vifor (International) Inc., Switzerland) in the therapy of iron deficiency anemia in chronic kidney disease patients who do not need dialysis. Eligible population included both male and female patients aged from 18 to 75 years old (inclusive) with diagnosed iron deficiency anemia or anemia of combined genesis (iron deficiency + anemia of chronic disease) that developed due to chronic kidney disease, who do not need dialysis and receive erythropoiesis-stimulating therapy.

Inclusion Criteria

  • Written Informed Consent;
  • Males and females aged from 18 to 75 years old, both inclusive;
  • Kidney disease stage 3-5 with no need for dialysis;
  • Regular administration of erythropoiesis-stimulating agents (erythropoietin, darbepoetin, etc. in stable dose with stable frequency) for at least 8 weeks before enrollment (randomization);
  • Hemoglobin < 115 g/l;
  • Transferrin saturation (TSAT) <25%; serum ferritin <300 ng/ml;
  • Patients should be able to follow the Protocol procedures (according to Investigator's assessment);
  • Patients and their sexual partners of childbearing potential should agree to implement highly effective contraception methods across the entire study (starting from signing the Informed Consent). This requirement does not apply to participants who have undergone surgical sterilization.

Exclusion Criteria


  • Any other causes of anemia except for renal anemia, including folate and B12 deficiency, chronic blood loss, and aluminum intoxication;
  • Isolated chronic disease anemia caused by any other inflammatory or non-inflammatory process (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 <80 g/l;
  • Body weight over 90 kg;
  • Dose modification for erythropoiesis-stimulating agents (erythropoietin, darbepoetin, etc.) within 8 weeks prior to randomization;
  • Parenteral iron products within 6 months before randomization;
  • Blood transfusion within 3 months before randomization;
  • Clinically relevant hemorrhages within 3 months before randomization;
  • Vaccination in less than 12 weeks before randomization;
  • Liver cirrhosis with portal hypertension and/or splenomegaly and/or ascitis;
  • HIV infection, active HBV or HCV, syphilis, active tuberculosis;
  • ALT or AST > 3 ULN;
  • Total bilirubin ≥ 1.5 ULN;
  • LDH > 3 ULN;
  • Documented bone marrow fibrosis;
  • Congestive heart failure (NYHA grade IV);
  • Resistant arterial hypertension
  • Unstable angina;
  • Bronchial asthma that requires regular therapy; 
  • Hemoglobinopathies, MDS, or malignant tumors involving hematopoietic and lymphoid tissues;
  • Hemochromatosis or hemosiderosis;
  • Severe secondary hyperparathyroidism (PTH > 800 pcg/ml);
  • 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;
  • Planned surgery (including vascular surgery such as fistula or catheter insertion for dialysis), dialysis or kidney transplant scheduled within the assumed period of study participation; 
  • Any acute inflammatory diseases or exacerbation of chronic inflammatory diseases including septic or aseptic inflammation foci;
  • 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); 
  • Malignant tumors, except for:
  • appropriately treated basal carcinoma and/or cervical cancer in situ;
  • any malignancies with complete remission over 5 years;
  • Alcohol or drug abuse;
  • Hypersensitivity to parenteral iron-containing drugs including iron(III)- hydroxide sucrose complex or any component of study medications;
  • History of allergic reactions to 2 or more drugs;
  • Female patients included in the study should not be pregnant or nursing;
  • Simultaneous participation in other clinical studies or previous participation in other clinical studies within 3 months from enrollment to the present trial.