Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease

Phase 3

Completed

• Conditions: Kidney Disease; Chronic Kidney Disease
• Interventions: Drug: darbepoetin alfa SF

• Registration Number: NCT00093977
• Lead Sponsor: Amgen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2004-10-07
• Study First Submitted QC: 2004-10-08
• Study First Posted: 2004-10-11
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-22
• Last Update Posted: 2013-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

• Currently diagnosed with Chronic Kidney Disease, either receiving or not receiving dialysis
• Anemic
• Currently on erythropoietic therapy
• Controlled hypertension
• Clinically stable

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
darbepoetin alfa SF	darbepoetin alfa SF	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
To characterize laboratory parameters in subjects with CKD	Entire Study