Overview

Fixed Dose NESP Study in Subjects With CRI

Status:
Completed
Trial end date:
2002-02-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Amgen
Treatments:
Darbepoetin alfa