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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
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.
Details
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 572 |
| Start date | 2004-03 |
| Completion | 2005-09 |
Conditions
- Anemia
Interventions
- epoetin alfa or beta
- methoxy polyethylene glycol-epoetin beta (Mircera)
- methoxy polyethylene glycol-epoetin beta (Mircera)
Primary outcomes
- Mean Change in Hemoglobin Concentration From Baseline to Evaluation Periods — Baseline (Week -4 to Week -1) and Evaluation period (Week 29 to Week 36)
A time adjusted mean change in hemoglobin (Hb) concentration was calculated using an area under the curve (AUC) approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The evaluation period is defined as Week 29 to Week 36.
Countries
United States, Belgium, Brazil, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Mexico, New Zealand, Panama, Poland, Puerto Rico, South Africa, Spain, Sweden, Taiwan, Thailand, United Kingdom