CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 65 enrolled
Drug / intervention
methoxy polyethylene glycol-epoetin beta [Mircera]drug
Likely dose
Mircera at differing doses and frequencies via subcutaneous injectionAI-extracted
Key inclusion· 3
  • ✓Adult patients 18 years of age or older
  • ✓Diagnosis of chronic renal anemia
  • ✓Not currently receiving renal replacement therapy (e.g., dialysis)
Key exclusion· 3
  • ✕Pregnant or breastfeeding women
  • ✕Women using unreliable birth control methods
  • ✕Receipt of any investigational drug within 30 days before screening or during run-in period

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

Search/NCT00048048
NCT00048048Phase 2Completed
CompareCT.gov

An Open-label, Randomized, Multi-centre, Multiple Dose Trial to Investigate the Efficacy and Safety of Subcutaneous Injections of RO0503821 at Different Dosing Intervals in Patients With Chronic Renal Anemia Who Are Not on Renal Replacement Therapy

Hoffmann-La Roche·interventional·Posted Oct 25, 2002·Updated Jan 2, 2018

In Brief

A Phase 2 clinical trial evaluating methoxy polyethylene glycol-epoetin beta [Mircera] for Anemia. Completed, enrolled 65 participants across 15 sites in 5 countries.

Detailed Summary

This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis. 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
CountriesCanada, Mexico, Poland, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 25, 2002
Enrollment StartMar 1, 2002
Primary CompletionOct 1, 2003
Study CompletionNov 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 23.7 years ago

Interventions

methoxy polyethylene glycol-epoetin beta [Mircera]drug

Differing doses and frequencies of sc administration