Phase 2 Study of Darbepoetin Alfa Extended Dosing

Pre-Dialysis Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Pre-Dialysis

Clinical Trial Details

NCT number	NCT00527215
Study type	Interventional
Source	Amgen
Contact
Status	Completed
Phase	Phase 2
Start date	March 2002
Completion date	October 2003

View Details

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