NCT00093977

Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease

An Open-label, Single-Arm Study to Assess the Safety of Darbepoetin Alfa Manufactured by a Serum Free Bioreactor Technology in Subjects With Chronic Kidney Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,100 (estimated)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether darbepoetin alfa manufactured by the current "roller bottle" technology and darbepoetin alfa manufactured by a serum free process have a comparable safety profile.

Conditions

• Kidney Disease
• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	darbepoetin alfa SF	Frequency of dosing depends on frequency at randomization: rHuEPO QW = darbepoetin alfa SF Q2W (dosing conversion table in protocol) rHuEPO biw or tiw = darbepoetin alfa SF QW (dosing conversion table in protocol) darbepoetin alfa RB = darbepoetin alfa SF at same dose and frequency PFS 10, 15, 20, 30, 40, 50, 60, 80, 100, 150, 200 or 300 mcg; Hb maintained between 11.0 - 13.0 g/dL

Timeline

• Start date: 2004-10-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2004-10-11
• Last updated: 2013-05-24