At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 75 enrolled
Drug / intervention
BCD-131 +1 morebiological
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.
Randomized Open-Label Comparative Study of the Efficacy and Safety of BCD-131 (JSC BIOCAD, Russia) and Mircera (F. Hoffmann-La Roche Ltd, Switzerland) in Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis
In Brief
A Phase 2 clinical trial evaluating BCD-131 and Mircera for Anemia. Completed, enrolled 75 participants across 3 sites in 2 countries.
Detailed Summary
BCD-131 is pegylated darbepoetin beta. BCD-131-2 is International Multicenter Randomized Open-Label Comparative Study (Phase II) of the Efficacy and Safety of BCD-131 and Mircera in Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia
CountriesBelarus, Russia
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
Enrollment StartOct 2017
First PostedMay 2018
Primary CompletionDec 2018
Study CompletionDec 2018
TodayJul 2026
First PostedMay 8, 2018
Enrollment StartOct 24, 2017
Primary CompletionDec 1, 2018
Study CompletionDec 10, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.2 years ago
Interventions
BCD-131biological
subcutaneously monthly
Mircerabiological
subcutaneously monthly