Darbepoetin Alfa Administered Once Every 4 Weeks in the Treatment of Subjects With Anemia of Cancer

Phase 2

Completed

• Conditions: Anemia

• Registration Number: NCT00095277
• Lead Sponsor: Amgen

Brief Summary

The purpose of this trial is to demonstrate benefit with respect to hematopoietic response in subjects with anemia of cancer randomized to Darbepoetin Alfa once every 4 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2004-11-02
• Study First Submitted QC: 2004-11-02
• Study First Posted: 2004-11-03
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-12
• Last Update Posted: 2009-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To demonstrate benefit with respect to hematopoietic response in subjects with anemia of cancer randomized to darbepoetin alfa once every 4 weeks.

Secondary Outcome Measures

Name	Time	Method
Assess safety of dose and frequency
Assess efficacy
Assess PROs
Assess relationship between PROs and hemoglobin concentration