CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 96 enrolled
Drug / intervention
Methoxy polyethylene glycol-epoetin betadrug
Likely dose
Methoxy polyethylene glycol-epoetin beta 200 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.

Search/NCT00737477
NCT00737477Phase 3Completed
CompareCT.gov

A Single Arm, Open-Label, Multicentre Study to Assess the Maintenance of Haemoglobin Levels With Once Monthly Subcutaneous Administration of C.E.R.A (Continuous Erythropoietin Receptor Activator) in Patients With Chronic Kidney Disease on Peritoneal Dialysis

Hoffmann-La Roche·interventional·Posted Aug 19, 2008·Updated Jun 23, 2017

In Brief

A Phase 3 clinical trial evaluating Methoxy polyethylene glycol-epoetin beta for Anemia. Completed, enrolled 96 participants across 52 sites.

Detailed Summary

This single-arm study will assess the efficacy and safety of monthly administration of SC Mircera for the maintenance of hemoglobin levels in participants with chronic kidney disease on peritoneal dialysis. Participants currently receiving maintenance treatment with SC erythropoietin stimulating agents (ESAs) will receive monthly SC injections of Mircera, with the starting dose derived from the last weekly ESA they had been receiving.

Study Details

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

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 19, 2008
Enrollment StartSep 30, 2008
Primary CompletionJul 31, 2011
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.9 years ago

Interventions

Methoxy polyethylene glycol-epoetin betadrug

Mircera will be administered SC every 4 weeks for a total of 48 weeks. The first dose of 120 or 200 mcg will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.