drugset / Trial / NCT00048048
A Study of Mircera in Anemic Patients With Chronic Kidney Disease Not Yet on Dialysis.
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2002-03
- Primary completion
- 2003-10
- Completion
- 2004-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 0.15 ug/kg | Subcutaneous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 0.3 ug/kg | Subcutaneous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 0.45 ug/kg | Subcutaneous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 0.6 ug/kg | Subcutaneous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 0.9 ug/kg | Subcutaneous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 1.2 ug/kg | Subcutaneous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 1.8 ug/kg | Subcutaneous |