Fixed Dose NESP Study in Subjects With CRI

A Pilot Study Evaluating Once Every Other Week Administration of Fixed Doses of Novel Erythropoiesis Stimulating Protein (NESP) to Subjects With Chronic Renal Insufficiency (CRI)

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.

Inclusion Criteria:

• Greater than or equal to 18 years of age
• CRI with a creatinine clearance of less than 40 mL/min
• Hemoglobin less than 11.0 g/dL
• Serum vitamin B12 and folate levels above the lower limit of normal and iron replete

Exclusion Criteria:

• Received rHuEPO therapy in the last 12 weeks
• Expected to initiate renal replacement therapy within 24 weeks or a recipient of a renal transplant
• Uncontrolled hypertension
• Seizure activity, CHF, hyperparathyroidism, major surgery, HIV-positive Pregnant or breast-feeding