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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00095264
First Posted: November 3, 2004
Last Update Posted: January 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Amgen
  Purpose
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 Intervention Phase
Myelodysplastic Syndromes Drug: Darbepoetin Alfa Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • The proportion of subjects achieving an erythroid response during the 13-week test period

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

Estimated Enrollment: 209
Study Start Date: October 2004
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00095264


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00095264     History of Changes
Other Study ID Numbers: 20030207
First Submitted: November 2, 2004
First Posted: November 3, 2004
Last Update Posted: January 15, 2010
Last Verified: January 2010

Keywords provided by Amgen:
Myelodysplastic Syndrome

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Darbepoetin alfa
Hematinics