NCT00526929

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pre-Dialysis

Interventions

Type	Name	Description
DRUG	darbepoetin alfa	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

Timeline

• Start date: 2000-05-01
• Primary completion: 2002-02-01
• Completion: 2002-02-01
• First posted: 2007-09-10
• Last updated: 2009-05-22