At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Randomized, Multicenter, Parallel-group Study to Demonstrate Correction of Anemia Using Once Every 4 Weeks Subcutaneous Injections of RO0503821 in Patients With Chronic Kidney Disease Who Are Not on Dialysis
In Brief
A Phase 3 clinical trial evaluating Methoxy polyethylene glycol-epoetin beta and Darbepoetin alfa for Renal Anemia, Chronic. Completed, enrolled 307 participants across 76 sites in 16 countries.
Detailed Summary
This study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous darbepoetin in the treatment of renal anemia in participants with chronic kidney disease who are not on dialysis and not receiving erythropoiesis-stimulating agents (ESA). Participants will be randomized to receive either Mircera once every 4 weeks, at a starting dose of 1.2 micrograms/kilogram (mcg/kg), or darbepoetin alfa once weekly, at a starting dose of 0.45 mcg/kg (or once every two weeks, 0.75 mcg/kg). The anticipated time on study treatment is 3-12 months.
Study Details
Timeline
Interventions
1.2 mcg/kg SC monthly, starting dose
0.45 mcg/kg SC weekly or 0.75 mcg/kg every 2 weeks, starting dose