CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 80 enrolled
Drug / intervention
methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera] +1 moredrug
Likely dose
methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera] 0.6 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/NCT00546481
NCT00546481Phase 3Completed
CompareCT.gov

An Open-label, Randomized, Multi-center, Parallel Group Study to Demonstrate Correction of Anemia Using Intravenous Injections of RO0503821 in Patients With Chronic Kidney Disease Who Are on Dialysis

Hoffmann-La Roche·interventional·Posted Oct 19, 2007·Updated Sep 19, 2016

In Brief

A Phase 3 clinical trial evaluating methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera] and Epoetin for Anemia. Completed, enrolled 80 participants across 7 sites.

Detailed Summary

This 2 arm study will evaluate the efficacy of intravenous Mircera treatment for the correction of anemia in patients with chronic kidney disease who are on dialysis. Patients will be randomized to receive either Mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin 3 times per week i.v. according to approved treatment recommendations. 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
CountriesSouth Korea
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 19, 2007
Enrollment StartNov 1, 2007
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 18.7 years ago

Interventions

methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera]drug

0.6 micrograms/kg every 2 weeks

Epoetindrug

As prescribed, iv, 3 times weekly