CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 86 enrolled
Drug / intervention
methoxy polyethylene glycol-epoetin beta [Mircera] +1 moredrug
Likely dose
Not stated in 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/NCT01156363
NCT01156363Phase 4Completed
CompareCT.gov

A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous and Intravenous MIRCERA® for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia

Hoffmann-La Roche·interventional·Posted Jul 2, 2010·Updated Dec 3, 2015

In Brief

A Phase 4 clinical trial evaluating Dialysis and methoxy polyethylene glycol-epoetin beta [Mircera] for Anemia. Completed, enrolled 86 participants across 3 sites.

Detailed Summary

This open label, single arm study will assess the efficacy for long-term maintenance of haemoglobin levels and the safety and tolerability of methoxy polyethylene glycol-epoetin beta \[Mircera\] in dialysis patients with chronic renal anaemia. Patients on regular long-term haemodialysis or peritoneal dialysis will receive monthly subcutaneous or intravenous Mircera for 6 months. Target sample size is \<200 patients.

Study Details

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

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2, 2010
Enrollment StartOct 1, 2010
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16 years ago

Interventions

Dialysisprocedure

regular haemodialysis or peritoneal dialysis

methoxy polyethylene glycol-epoetin beta [Mircera]drug

once monthly, subcutaneously or intravenously, for 32 weeks