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.