drugset / Trial / NCT00081484
A Study of Intravenous or Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
Timeline
- Start
- 2004-06
- Primary completion
- 2006-03
- Completion
- 2006-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | epoetin alfa | Protein / enzyme biologic | — | Intravenous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 30 ug | Intravenous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 50 ug | Intravenous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 90 ug | Intravenous |