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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
10 mcg NESP administered SC every other week 15 mcg NESP administered SC every other week 20 mcg NESP administered SC every other week 30 mcg NESP administered SC every other week 40 mcg NESP administered SC every other week 50 mcg NESP administered SC every other week 60 mcg NESP administered SC every other week 80 mcg NESP administered SC every other week 100 mcg NESP administered SC every other week
To determine the effectiveness of fixed dose(s) of NESP, administered once every other week, in the treatment of anemia in subjects with CRI
Time frame: entire study - 24 weeks
To assess the safety and tolerability of chronic NESP therapy
Time frame: entire study - 24 weeks
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