Last updated on February 2018

Safety and Efficacy Study of BCD-066 Compared to Aranesp for Anemia Treatment in Chronic Kidney Disease Patients

Brief description of study

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.

Detailed Study Description

In this study CKD patients on dialysis previously treated by short-acting epoetins will switch to one of darbepoetin alfa products - BCD-066 (experimental arm) or Aranesp (active comparator) to maintain previously achieved target level of hemoglobin (100-120 g/l).

Patients will be treated for 52 weeks. IV iron supplementation will be provided to maintain serum ferritin level above 500 g/l according to KDIGO Anemia Guidelines (2012).

Clinical Study Identifier: NCT02506868

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Tula Regional Hospital

Tula, Russian Federation
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Recruitment Status: Open

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