At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 147 enrolled
Drug / intervention
Darbepoetin alfa +1 moredrug
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.
A Multicenter, Randomised, Double-blind, Placebo-controlled Study of Darbepoetin Alfa for the Treatment of Anaemic Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
In Brief
A Phase 3 clinical trial evaluating Darbepoetin alfa and Placebo for MDS. Completed, enrolled 147 participants across 72 sites in 9 countries.
Detailed Summary
The primary objective was to assess the superiority of darbepoetin alfa versus placebo on the incidence of red blood cell transfusions during the 24-week double-blind treatment period in anemic patients with low or intermediate-1 risk MDS.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMDS
CountriesAustria, Belgium, Czechia, France, Germany, Greece, Italy, Spain, Switzerland
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2011
Enrollment StartDec 2011
Primary CompletionFeb 2015
Study CompletionSep 2017
TodayJul 2026
First PostedMay 30, 2011
Enrollment StartDec 21, 2011
Primary CompletionFeb 11, 2015
Study CompletionSep 14, 2017
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 15.1 years ago
Interventions
Darbepoetin alfadrug
Administered by subcutaneous injection every 3 weeks
Placebodrug
Administered by subcutaneous injection every 3 weeks