CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 208 enrolled
Drug / intervention
Methoxy polyethylene glycol-epoetin betadrug
Likely dose
Methoxy polyethylene glycol-epoetin beta 360 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/NCT00550680
NCT00550680Phase 3Completed
CompareCT.gov

A Single Arm, Open Label Study to Assess the Efficacy, Safety, and Tolerability of Once-Monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia

Hoffmann-La Roche·interventional·Posted Oct 30, 2007·Updated Mar 30, 2016

In Brief

A Phase 3 clinical trial evaluating Methoxy polyethylene glycol-epoetin beta for Chronic Renal Anemia. Completed, enrolled 208 participants across 24 sites.

Detailed Summary

This single-arm study will assess the efficacy and safety of intravenous (IV) Mircera when administered for the maintenance of hemoglobin (Hb) levels in participants with chronic renal anemia. Individuals currently receiving maintenance treatment with epoetin alfa or darbepoetin alfa will receive monthly injections of Mircera, with the starting dose (120, 200, or 360 micrograms \[mcg\] IV injection) derived from the dose of epoetin alfa or darbepoetin alfa they were receiving in the week preceding study start.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Renal Anemia
CountriesGreece
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 30, 2007
Enrollment StartJan 1, 2008
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 18.7 years ago

Interventions

Methoxy polyethylene glycol-epoetin betadrug

Participants will receive a starting dose of 120, 200, or 360 mcg via IV injection. Thereafter, the once-monthly dose will be titrated to achieve target Hb concentrations.