Study Complete
Sponsor ID
990151
Fixed Dose NESP Study in Subjects with CRI
Study Details
Multicenter, open-label, single-arm, fixed dose study of darbepoetin alfa in subjects with Chronic Renal Insufficiency (CRI). Subjects will be screened for 2 weeks during which time blood will be drawn and vital signs will be taken. Upon enrollment, subjects will receive SC darbepoetin alfa administered once every other week for 24 weeks. Darbepoetin alfa will be titrated in fixed-dose steps to maintain a hemoglobin of 11.0 - 13.0. During the study, laboratory assessments will be completed and vital signs will be taken. Subjects will enter a 1-week post-treatment observation and evaluation period after the last dose of study drug.
Protocol Summary
Primary Outcome Measures
To determine the effectiveness of fixed dose(s) of NESP, administered once every other week, in the treatment of anemia in subjects with CRI
Timeframe: entire study - 24 weeks
Secondary Outcome Measures
To assess the safety and tolerability of chronic NESP therapy
Timeframe: entire study - 24 weeks
Locations
No locations found.