CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 91 enrolled
Drug / intervention
methoxy polyethylene glycol-epoetin beta [Mircera]drug
Likely dose
Methoxy polyethylene glycol-epoetin beta (Mircera) at differing doses and frequencies (IV)AI-extracted
Key inclusion· 4
  • ✓Age ≥18 years
  • ✓Diagnosis of chronic renal anemia
  • ✓On hemodialysis for at least 3 months
  • ✓Receiving IV epoetin alfa in the 2 weeks prior to run-in
Key exclusion· 2
  • ✕Pregnant, breastfeeding, or using unreliable contraception
  • ✕Use of any investigational drug within 30 days before run-in, or during run-in/study treatment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00048035
NCT00048035Phase 2Completed
CompareCT.gov

An Open-label, Multicenter, Randomized Study to Determine Dose Conversion Factors at Different Frequencies of Administration After Switching From Maintenance Treatment With Intravenous Epoetin Alfa to Maintenance Treatment With Intravenous RO0503821 in Hemodialysis Patients With Chronic Renal Anemia.

Hoffmann-La Roche·interventional·Posted Oct 25, 2002·Updated Dec 20, 2016

In Brief

A Phase 2 clinical trial evaluating methoxy polyethylene glycol-epoetin beta [Mircera] for Anemia. Completed, enrolled 91 participants across 14 sites.

Detailed Summary

This study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 25, 2002
Enrollment StartMar 1, 2002
Primary CompletionJun 1, 2005
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 23.7 years ago

Interventions

methoxy polyethylene glycol-epoetin beta [Mircera]drug

Differing doses and frequencies of iv administration