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An Open-label, Randomized, Multi-centre, Multiple Dose Trial to Investigate the Efficacy and Safety of Subcutaneous Injections of RO0503821 at Different Dosing Intervals in Patients With Chronic Renal Anemia Who Are Not on Renal Replacement Therapy
This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis. 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 | 65 |
| Start date | 2002-03 |
| Completion | 2004-11 |
Conditions
- Anemia
Interventions
- methoxy polyethylene glycol-epoetin beta [Mircera]
Primary outcomes
- The Change in Hemoglobin Over Time Between Baseline and End of Initial Treatment Based on Individual Regression Slopes — From Baseline (Day -28 to Day 1) to EOIT (Week 19)
The primary efficacy variable was blood Hb level and its changes from Baseline (defined as the mean Hb of Screening assessment (SA) (Week -3), Weeks -2 and -1 of the Run-in period) over time during the core treatment period. For each participant, the primary efficacy parameter was the change in hemoglobin level over time based on regression slopes. All values until end-of-initial treatment (EOIT), defined as the last observed value before a dose change or blood transfusion, were included in the calculation of this endpoint. For participants without any dose adjustments, the EOIT value was identical to the value for Week 19.
Countries
United States, Canada, Mexico, Poland, United Kingdom