CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 35 enrolled
Drug / intervention
methoxy polyethylene glycol-epoetin betadrug
Likely dose
methoxy polyethylene glycol-epoetin beta 1.2 mcg/kgfrom 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/NCT00642668
NCT00642668Phase 4Completed
CompareCT.gov

Subcutaneous Treatment of Anemia in Patients With a GFR Below 45 ml/Min/1.73m2 Through Injections With Mircera as Low Frequent as Once Monthly (STABILO)

Hoffmann-La Roche·interventional·Posted Mar 25, 2008·Updated Jul 5, 2017

In Brief

A Phase 4 clinical trial evaluating methoxy polyethylene glycol-epoetin beta for Anemia. Completed, enrolled 35 participants across 32 sites.

Detailed Summary

This single arm study assessed the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera), a continuous erythropoietin receptor activator (C.E.R.A.), for correction and/or maintenance of hemoglobin levels in participants with chronic kidney disease and renal anemia, who were not treated with erythropoiesis-stimulating agents (ESA) or on dialysis. Eligible participants received monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta at an initial recommended dose of 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment was 3-10 months, and the target sample size was 200 individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia
CountriesBelgium
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 25, 2008
Enrollment StartJun 30, 2008
Primary CompletionDec 31, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.3 years ago

Interventions

methoxy polyethylene glycol-epoetin betadrug

1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)