Fixed Dose NESP Study in Subjects With CRI

• Status: Completed
• Trial end date: 2002-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Darbepoetin alfa

Criteria

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