Fixed Dose NESP Study in Subjects With CRI

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.

Timeline

Start

2000-05

Primary completion

2002-02

Completion

2002-02

Publications

• Results Suranyi MG, Lindberg JS, Navarro J, Elias C, Brenner RM, Walker R. Treatment of anemia with darbepoetin alfa administered de novo once every other week in chronic kidney disease. Am J Nephrol. 2003 Mar-Apr;23(2):106-11. doi: 10.1159/000068041.

Drugs

Indications

No indication recorded.