NCT00121602

Efficacy Study: Darbepoetin Alfa for the Treatment of Anemia in Patients With Chronic Kidney Disease

Randomized, Double-Blind, Equivalence Study of the Efficacy of Darbepoetin Alfa Manufactured by Serum Free Bioreactor Technology and Darbepoetin Alfa Manufactured by Roller-Bottle Technology for the Treatment of Anemia in Patients With Chronic Kidney Disease Receiving Hemodialysis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 446 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether the efficacy of darbepoetin alfa SF is equivalent to that of darbepoetin alfa RB for the treatment of anemia in patients with chronic kidney disease (CKD) receiving hemodialysis.

Conditions

• Anemia
• Kidney Disease

Interventions

Type	Name	Description
DRUG	Darbepoetin Alfa	Initial dose, frequency and route of administration of study drug will be the same as that administered for darbepoetin alfa prior to enrollment. Frequency either once a week or once every two weeks, frequency may not change for duration of study. Route of administration either subcutaneous or intravenous, route of administration may not change for duration of study. Study drug provided in pre-filled syringes at the following unit doses: 10, 15, 20, 30, 40, 50, 60, 80, 100 or 150 ug.

Timeline

• Start date: 2005-03-01
• Primary completion: 2005-10-01
• Completion: 2006-10-01
• First posted: 2005-07-21
• Last updated: 2008-02-28