CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 20 enrolled
Drug / intervention
methoxy polyethylene glycol-epoetin beta [C.E.R.A.]drug
Likely dose
methoxy polyethylene glycol-epoetin beta [C.E.R.A.] 300 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/NCT00642304
NCT00642304Phase 3Completed
CompareCT.gov

A Single Arm Open Label Study to Assess Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneously C.E.R.A. for the Maintenance of Hemoglobin Levels in Patients With Chronic Renal Anemia Not on Dialysis

Hoffmann-La Roche·interventional·Posted Mar 25, 2008·Updated Jun 26, 2018

In Brief

A Phase 3 clinical trial evaluating methoxy polyethylene glycol-epoetin beta [C.E.R.A.] for Anemia. Completed, enrolled 20 participants across 23 sites.

Detailed Summary

This single arm study will assess the efficacy and safety of subcutaneous C.E.R.A. when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of C.E.R.A., with the starting dose (120, 200 or 300 micrograms \[mcg\] subcutaneously \[SC\]) derived from the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding study start.

Study Details

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

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 25, 2008
Enrollment StartMar 27, 2008
Primary CompletionDec 9, 2009
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 18.3 years ago

Interventions

methoxy polyethylene glycol-epoetin beta [C.E.R.A.]drug

Methoxy polyethylene glycol-epoetin beta is administered SC every four week up to Week 20.The starting dose is 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta participants shall be receiving in the week preceding the study start. Further dose adjustment during the study depending on the hemoglobin (Hb) values.