At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 196 enrolled
Drug / intervention
Darbepoetin alfadrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicenter Double-blind Randomized Parallel Comparative Study of Efficacy and Safety of BCD-066 (CJSC BIOCAD, Russia) and Aranesp (Amgen Europe B.V., Netherlands) in Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis
In Brief
A Phase 3 clinical trial evaluating Darbepoetin alfa for Chronic Kidney Disease and 2 related conditions. Completed, enrolled 196 participants across 30 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesRussia
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 2015
Enrollment StartAug 2015
Primary CompletionJan 2017
Study CompletionDec 2017
TodayJul 2026
First PostedJul 23, 2015
Enrollment StartAug 8, 2015
Primary CompletionJan 8, 2017
Study CompletionDec 21, 2017
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 10.9 years ago
Interventions
Darbepoetin alfadrug
Weekly sc administration of darbepoetin alfa