A Study of Darbepoetin Alfa in Anemic Subjects With Low Risk Myelodysplastic Syndrome

Phase 2

Completed

• Conditions: Myelodysplastic Syndromes

• Registration Number: NCT00095264
• Lead Sponsor: Amgen

Brief Summary

The purpose of this study is to assess the effect of 13 weeks of darbepoetin alfa treatment on erythroid response in anemic subjects with low risk Myelodysplastic Syndrome (MDS).

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: 2010-01
• Last Update Submitted: 2010-01-14
• Last Update Posted: 2010-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The proportion of subjects achieving an erythroid response during the 13-week test period

Secondary Outcome Measures

Name	Time	Method
The proportion of subjects achieving an erythroid response during the 28-week treatment period
The incidence of red blood cell (RBC) transfusions (greater than or equal to 1 unit)
The change in FACT-F from baseline
The change in Hb from baseline