At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 358 enrolled
Drug / intervention
darbepoetin alfadrug
Likely dose
darbepoetin alfa 600 mcgfrom 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 Study Comparing De Novo Once Monthly and Once Every 2 Week Darbepoetin Alfa Dosing for the Correction of Anemia in Subjects With Chronic Kidney Disease Not Receiving Dialysis
In Brief
A Phase 3 clinical trial evaluating darbepoetin alfa for Anemia and Chronic Kidney Disease. Completed, enrolled 358 participants across 157 sites in 23 countries.
Detailed Summary
The purpose of this study is to determine whether once monthly (QM) dosing of darbepoetin alfa is non-inferior to that of once every 2 week (Q2W) dosing of darbepoetin alfa for the correction of anemia in patients with Chronic Kidney Disease who are not receiving dialysis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia, Chronic Kidney Disease
CountriesAustralia, Belgium, Bulgaria, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, Israel, Italy, Latvia, Mexico, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, Spain, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2009
First PostedJun 2009
Primary CompletionApr 2012
Study CompletionMay 2012
TodayJul 2026
First PostedJun 22, 2009
Enrollment StartJun 1, 2009
Primary CompletionApr 1, 2012
Study CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.0 years ago
Interventions
darbepoetin alfadrug
Drug administered either Q2W or QM using a prefilled syringe. Allowable doses of: 10, 20, 30, 40, 50, 60, 80, 100, 130, 150, 200, 300, 400 or 600 mcg.