BCD-131 is pegylated darbepoetin beta. This clinical study BCD-131-3 is a randomized, open-label, phase III study of the efficacy and safety of BCD-131 and Mircera used for the treatment of anemia in end-stage chronic kidney disease (CKD) patients on dialysis.
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.
Any other diagnosed forms of anemia, except for anemia of renal disease, including anemia in chronic diseases (C-reactive protein level >20 mg/L at screening).
Diagnosed lupus nephritis or chronic kidney disease due to systemic vasculitis.
Platelet count <100×109/L based on the results of screening examination.
A high probability of early withdrawal from the study, in particular a planned (i.e., available information about a planned date and/or a suitable donor) kidney transplant surgery during the estimated period of participation in the study.
Parallel
BCD-131 (pegdarbepoetin beta)
Biological/VaccineBCD-131 (pegdarbepoetin beta), subcutaneous injection; regimen: once every 4 weeks; therapy duration: 52 weeks
Mircera (methoxypolyethylene glycol-epoetin beta)
Biological/VaccineMircera (methoxypolyethylene glycol-epoetin beta), subcutaneous injection; regimen: once every 4 weeks; therapy duration: 52 weeks
Proportion of subjects (%) with the target hemoglobin level (100-120 g/L inclusive)
Proportion of subjects (%) with the target hemoglobin level (100-120 g/L inclusive) during the last month of therapy
Proportion of subjects (%) with a mean hemoglobin level at the time of assessment within the range of ±10 g/L from baseline
Proportion of subjects (%) with a mean hemoglobin level at the time of assessment within the range of ±10 g/L from baseline
Proportion of subjects (%) who required dose adjustment of the test drug/reference drug during the maintenance therapy stage of the main study period
In the main study period, a dose adjustment is expected during the first 12 weeks of therapy (titration phase), and a maintenance therapy stage is expected during the subsequent weeks of the main study period.