At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 137 enrolled
Drug / intervention
methoxy polyethylene glycol-epoetin beta [Mircera]drug
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.
An Open-label, Multicenter, Randomized Study to Determine Dose Conversion Factors at Different Frequencies of Administration After Switching From Maintenance Treatment With Subcutaneous Epoetin Alfa or Beta to Maintenance Treatment With Subcutaneous RO0503821 in Dialysis Patients With Chronic Renal Anemia
In Brief
A Phase 2 clinical trial evaluating methoxy polyethylene glycol-epoetin beta [Mircera] for Anemia. Completed, enrolled 137 participants across 23 sites in 4 countries.
Detailed Summary
This study will determine the appropriate dose and frequency of administration of sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. 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
CountriesGermany, Italy, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2001
Primary CompletionJul 2005
First PostedAug 2006
TodayJul 2026
First PostedAug 16, 2006
Enrollment StartOct 1, 2001
Primary CompletionJul 1, 2005
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 19.9 years ago
Interventions
methoxy polyethylene glycol-epoetin beta [Mircera]drug
Differing doses and frequencies of sc administration