CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 572 enrolled
Drug / intervention
epoetin alfa or beta +2 moredrug
Likely dose
Methoxy polyethylene glycol-epoetin beta (Mircera) 60, 100, or 180 micrograms subcutaneously every 2 or 4 weeksAI-extracted
Key inclusion· 4
  • ✓Adult age ≥18 years
  • ✓Chronic renal anemia
  • ✓On dialysis therapy for at least 12 weeks before screening
  • ✓Receiving subcutaneous epoetin for at least 8 weeks before screening
Key exclusion· 2
  • ✕Pregnancy, breastfeeding, or unreliable birth control
  • ✕Investigational drug within 4 weeks before screening or during study

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

Search/NCT00077623
NCT00077623Phase 3Completed
CompareCT.gov

A Randomized, Controlled, Open-Label, Multi- Center, Parallel-Group Study to Demonstrate the Efficacy and Safety of RO0503821 When Administered Subcutaneously for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Dialysis

Hoffmann-La Roche·interventional·Posted Feb 13, 2004·Updated May 25, 2016

In Brief

A Phase 3 clinical trial evaluating epoetin alfa or beta and methoxy polyethylene glycol-epoetin beta (Mircera) for Anemia. Completed, enrolled 572 participants across 90 sites in 21 countries.

Detailed Summary

This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia
CountriesBelgium, Brazil, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Mexico, New Zealand, Panama, Poland, Puerto Rico, South Africa, Spain, Sweden, Taiwan, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 13, 2004
Enrollment StartMar 1, 2004
Primary CompletionSep 1, 2005
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 22.4 years ago

Interventions

epoetin alfa or betadrug

iv 3 times weekly, as prescribed

methoxy polyethylene glycol-epoetin beta (Mircera)drug

60, 100 or 180 micrograms sc (starting dose) every 2 weeks

methoxy polyethylene glycol-epoetin beta (Mircera)drug

60, 100 or 180 micrograms sc (starting dose) every 4 weeks