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

• Sponsor: Amgen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00095264
• Collaborator: (none)
• Enrollment: 209

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndromes	Drug: Darbepoetin Alfa	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study of Darbepoetin Alfa in Anemic Subjects With Low Risk Myelodysplastic Syndrome
• Study Start Date: Oct 1, 2004

Outcome Measures

Primary Outcome Measures

1. The proportion of subjects achieving an erythroid response during the 13-week test period []

Secondary Outcome Measures

1. The proportion of subjects achieving an erythroid response during the 28-week treatment period []

2. The change in Hb from baseline []

3. The incidence of red blood cell (RBC) transfusions (greater than or equal to 1 unit) []

4. The change in FACT-F from baseline []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Eligibility Criteria: General: - Low risk MDS (low or intermediate-1 risk as defined by IPSS) and FAB classification of RA, RARS, or RAEB with blasts less than or equal to 10% determined via a bone marrow biopsy and CBC - Adequate iron stores determined by bone marrow film or section staining for iron via a bone marrow biopsy - ECOG Performance status score of 0, 1, or 2 Laboratory: - Local laboratory screening Hgb less than or equal to 11.0g/dL - Adequate renal function (serum creatinine concentration less than or equal to 2.0 mg/dL) - Adequate liver function (total bilirubin less than or equal to 2 times, ALT less than or equal to 3 times, and AST less than or equal to 3 times the upper limit of the respective normal range) Ethical: - Must be 18 years of age or older - Provide written Institutional Review Board (IRB)-approved informed consent before any screening procedures are performed

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Amgen

Investigators

• Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• AmgenTrials clinical trials website
• Notice regarding posted summaries of trial results
• To access clinical trial results information click on this link
• FDA-approved Drug Labeling

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00095264
• Other Study ID Numbers: 20030207
• First Posted: Nov 3, 2004
• Last Update Posted: Jan 15, 2010
• Last Verified: Jan 1, 2010

• Keywords provided by , ,: Myelodysplastic Syndrome
• Additional relevant MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome; Darbepoetin alfa

Study Results

No Results Posted as of Jan 15, 2010