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An Open-label, Multicenter, Randomized Study to Determine Dose Conversion Factors at Different Frequencies of Administration After Switching From Maintenance Treatment With Intravenous Epoetin Alfa to Maintenance Treatment With Intravenous RO0503821 in Hemodialysis Patients With Chronic Renal Anemia.
This study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.
Details
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 91 |
| Start date | 2002-03 |
| Completion | 2005-06 |
Conditions
- Anemia
Interventions
- methoxy polyethylene glycol-epoetin beta [Mircera]
Primary outcomes
- Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen — From Baseline (Day -28 to Day 1) to EOIT (Week 19)
Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported. For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks. Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week -1). For all participants, an EOIT value was calculated as the last observed Hb value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 value.
Countries
United States