Study Complete
Sponsor ID
990151

Fixed Dose NESP Study in Subjects with CRI

Sponsor ID
990151
Clinicaltrials.gov ID
NCT00526929
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 2
Product
darbepoetin alfa
Type
Interventional
Masking
None (Open Label)
Enrollment
75
Additional Study Details

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.