Study Complete
Sponsor ID
20010212
Phase 2 Study of Darbepoetin alfa Extended Dosing
Study Details
Multicenter, open label single arm study in which 140 subjects with CRI who are currently receiving SC darbepoetin alfa once every other week will receive darbepoetin alfa once every 4 weeks for 24 weeks. Upon enrollment into this study, subjects will receive darbepoetin alfa once every 4 weeks for 24 weeks. The initial dose will be equivalent to the subject's total dose in the month preceding enrollment. Doses may be titrated to maintain the Hb concentration in the target range.
Protocol Summary
Primary Outcome Measures
To assess the proportion of CRI subjects maintaining a target hemoglobin (Hb) range of 10.0 to 12.0 g/dL when administered subcutaneous (SC) darbepoetin alfa once every 4 weeks
Timeframe: Study weeks 21 - 29
Secondary Outcome Measures
To assess the safety, toleratbility, and pharmacokinetic (PK) profile of darbepoetin alfa when administered once every 4 weeks.
Timeframe: Entire study
Locations
No locations found.