Who is sponsoring NCT00093977?

NCT00093977 is sponsored by Amgen.

What condition does NCT00093977 study?

NCT00093977 studies Kidney Disease, Chronic Kidney Disease.

What drugs are being tested in NCT00093977?

Interventions: darbepoetin alfa SF.

What is the status of NCT00093977?

NCT00093977 is currently COMPLETED.

Last reviewed 2013-05-22 · How we verify

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

NCT00093977 Phase 3 COMPLETED

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.

Details

Lead sponsor	Amgen
Phase	Phase 3
Status	COMPLETED
Enrolment	1100
Start date	2004-10
Completion	2007-01

Conditions

Kidney Disease
Chronic Kidney Disease

Interventions

darbepoetin alfa SF

Primary outcomes

To determine whether darbepoetin alfa manufactured by a roler bottle technology (darbepoetin alfa RB) and darbepoetin alfa manufactured by a serum free process (darbepoetin alfa SF) have a comparable safety profile — Entire Study