At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Chronic renal anemia
- ✓On dialysis therapy for at least 12 weeks before screening
- ✓Receiving darbepoetin alfa intravenously for at least 8 weeks before screening
- ✕Pregnant, breastfeeding, or using unreliable contraception
- ✕Administration of another investigational drug within 4 weeks before screening or during the study
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Controlled, Open-label, Multi-center, Parallel-group Study to Demonstrate the Efficacy and Safety of RO0503821 When Administered Intravenously for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Dialysis.
In Brief
A Phase 3 clinical trial evaluating Darbepoetin alfa and methoxy polyethylene glycol-epoetin beta [Mircera] for Anemia. Completed, enrolled 313 participants across 48 sites in 12 countries.
Detailed Summary
This study will assess the efficacy and safety of intravenous (iv) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv darbepoetin alfa. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
Study Details
Timeline
Interventions
Darbepoetin alfa was administered IV, every week or every 2 weeks during Weeks 1 through 52.
RO0503821 was administered IV, every 2 weeks during Weeks 1 through 52. The starting dose of RO0503821 (60, 100, or 180 micro gram \[µg\]) was based on the dose of darbepoetin alfa at the time of randomization (\< 40, 40 to 80, or \> 80 µg per week, respectively).