At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 132 enrolled
Drug / intervention
methoxy polyethylene glycol-epoetin betadrug
Likely dose
methoxy polyethylene glycol-epoetin beta 360 microgramsfrom 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.
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 Haemodialysis Patients With Chronic Renal Anaemia.
In Brief
A Phase 3 clinical trial evaluating methoxy polyethylene glycol-epoetin beta for Anemia. Completed, enrolled 132 participants across 20 sites.
Detailed Summary
This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients will receive 4-weekly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia
CountriesTurkey (Türkiye)
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2008
Enrollment StartMay 2008
Primary CompletionJun 2010
TodayJul 2026
First PostedApr 18, 2008
Enrollment StartMay 14, 2008
Primary CompletionJun 22, 2010
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 18.2 years ago
Interventions
methoxy polyethylene glycol-epoetin betadrug
120, 200 or 360 micrograms iv every 4 weeks (starting dose)