drugset / Trial / NCT00642304
A Study of Subcutaneous C.E.R.A. for the Maintenance of Hemoglobin Levels in Participants With Chronic Renal Anemia Not on Dialysis.
NaSingle-groupOpen-labelTreatment
Summary
This single arm study will assess the efficacy and safety of subcutaneous C.E.R.A. when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of C.E.R.A., with the starting dose (120, 200 or 300 micrograms \[mcg\] subcutaneously \[SC\]) derived from the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding study start.
Timeline
- Start
- 2008-03-27
- Primary completion
- 2009-12-09
- Completion
- 2009-12-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 120 ug | Subcutaneous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 200 ug | Subcutaneous |
| Subject | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 300 ug | Subcutaneous |