drugset / Trial / NCT00077623
A Study of Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients.
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2004-03
- Primary completion
- 2005-09
- Completion
- 2005-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | epoetin alfa | Protein / enzyme biologic | — | Intravenous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 60 ug | Subcutaneous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 100 ug | Subcutaneous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 120 ug | Subcutaneous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 180 ug | Subcutaneous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 200 ug | Subcutaneous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 360 ug | Subcutaneous |