drugset / Trial / NCT00560547
A Study of Once-Monthly Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia.
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This single arm study will assess the long-term maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in hemodialysis patients with chronic renal anemia. Patients currently receiving darboepoetin alfa or epoetin alfa maintenance treatment will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/4 weeks (based on the ESA dose administered on week-1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10.5-12.5g/dL. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Timeline
- Start
- 2007-10
- Primary completion
- —
- Completion
- 2009-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 120 ug | Intravenous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 200 ug | Intravenous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 360 ug | Intravenous |