CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 64 enrolled
Drug / intervention
Methoxy Polyethylene Glycol-Epoetin Betadrug
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.

Search/NCT00717366
NCT00717366Phase 2Completed
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An Open-Label Multi-center, Multiple Dose Study to Determine the Optimum Starting Dose of Intravenous MIRCERA for Maintenance Treatment of Anemia in Pediatric Participants With Chronic Kidney Disease on Hemodialysis

Hoffmann-La Roche·interventional·Posted Jul 17, 2008·Updated Sep 8, 2017

In Brief

A Phase 2 clinical trial evaluating Methoxy Polyethylene Glycol-Epoetin Beta for Renal Anemia. Completed, enrolled 64 participants across 39 sites in 12 countries.

Detailed Summary

This sequential study will assess the efficacy and safety of multiple doses of intravenous (IV) methoxy polyethylene glycol-epoetin beta (MIRCERA), and will determine the optimum starting dose for maintenance treatment of anemia in children with chronic kidney disease on hemodialysis. Pediatric participants will remain on epoetin alfa, epoetin beta or darbepoetin alfa during the screening period, after which they will receive IV MIRCERA monthly, at a starting dose related to the previous weekly epoetin or darbepoetin alfa dose. Depending on the response achieved, another group may be selected to receive a higher or a lower dose.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Anemia
CountriesAustralia, Belgium, France, Germany, Hungary, Italy, Poland, Romania, Russia, Spain, Thailand, Ukraine
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 17, 2008
Enrollment StartJul 1, 2008
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 18.0 years ago

Interventions

Methoxy Polyethylene Glycol-Epoetin Betadrug

Will be administered IV, every 4 weeks.