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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Kaluga Region Hospital

Kaluga, Russian Federation
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Fresenius Medical Care Kuban

Krasnodar, Russian Federation
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NEFROS Ltd, Medical Centre

Krasnodar, Russian Federation
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Centr Dializa Ltd

Moscow, Russian Federation
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City Clinical Hospital #24

Moscow, Russian Federation
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Nefrolayn-Novosibirsk Ltd

Novosibirsk, Russian Federation
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City Mariin Hospital

St. Petersburg, Russian Federation
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City Hospital #40, Kurortny district

St. Petersburg, Russian Federation
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Nikolaevskaya Hospital

St. Petersburg, Russian Federation
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B.Braun Avitum Russland Clinics Ltd.

St.Petersburg, Russian Federation
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Centr Dializa Sankt-Peterburg Ltd

St.Petersburg, Russian Federation
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City Hospital #15

St.Petersburg, Russian Federation
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Tula Regional Hospital

Tula, Russian Federation
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Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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