CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 490 enrolled
Drug / intervention
Darbepoetin alfa +1 moredrug
Likely dose
methoxy polyethylene glycol-epoetin beta [Mircera] 360 microgramsfrom 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.

Search/NCT00394953
NCT00394953Phase 3Completed
CompareCT.gov

A Randomized, Controlled, Open Label, Multicenter, Parallel-group Study to Compare the Effect of Mircera With That of Darbepoetin Alfa, Administered Intravenously at Extended Dosing Intervals, for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Hemodialysis

Hoffmann-La Roche·interventional·Posted Nov 2, 2006·Updated Jan 20, 2017

In Brief

A Phase 3 clinical trial evaluating Darbepoetin alfa and methoxy polyethylene glycol-epoetin beta [Mircera] for Anemia. Completed, enrolled 490 participants across 88 sites in 14 countries.

Detailed Summary

This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa, administered at extended dosing intervals, in the maintenance treatment of anemia in patients with chronic kidney disease (CKD) who are on hemodialysis. Eligible patients receiving once-weekly intravenous (IV) darbepoetin alfa maintenance treatment will be randomized to receive either intravenous Mircera once a month (at a starting dose of 120, 200 or 360 micrograms/month, depending on the weekly dose of darbepoetin alfa prior to start of study) or intravenous darbepoetin alfa every 2 weeks before switching to once monthly administration. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia
CountriesAustralia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2, 2006
Enrollment StartDec 1, 2006
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 19.7 years ago

Interventions

Darbepoetin alfadrug

As prescribed, iv.

methoxy polyethylene glycol-epoetin beta [Mircera]drug

120, 200 or 360 micrograms iv / month, starting dose