NCT00527215

Phase 2 Study of Darbepoetin Alfa Extended Dosing

A Study of Darbepoetin Alfa Administered Once Every Four Weeks in Chronic Renal Insufficiency (CRI) Subjects With Anemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, open label single arm study in which 140 subjects with CRI who are currently receiving SC darbepoetin alfa once every other week will receive darbepoetin alfa once every 4 weeks for 24 weeks. Upon enrollment into this study, subjects will receive darbepoetin alfa once every 4 weeks for 24 weeks. The initial dose will be equivalent to the subject's total dose in the month preceding enrollment. Doses may be titrated to maintain the Hb concentration in the target range.

Conditions

• Pre-Dialysis

Interventions

Type	Name	Description
DRUG	darbepoetin alfa	starting dose determined by calculating a subject's total dose in the month preceding enrollment. Administered QM for 25 weeks. Change made as necessary to maintain a hemoglobin concentration within the target range os 10.0 - 12.0 g.dL

Timeline

• Start date: 2002-03-01
• Primary completion: 2003-10-01
• Completion: 2003-10-01
• First posted: 2007-09-10
• Last updated: 2009-05-22