Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease

Amgen

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease; Kidney Disease

Treatments: Drug: darbepoetin alfa SF

Study type: Interventional

Funder types: Industry

Identifiers

NCT00093977

20040180

Details and patient eligibility

About

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.

Enrollment: 1,100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,100 participants in 1 patient group

darbepoetin alfa SF

Experimental group

Treatment:

Drug: darbepoetin alfa SF