NCT Number: NCT00095264
A Study of Darbepoetin Alfa in Anemic Subjects With Low Risk Myelodysplastic Syndrome
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).
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
The proportion of subjects achieving an erythroid response during the 13-week test period
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Amgen
Industry
Registry information
Important dates
- Study start
- 2004
- First posted
- Nov 3, 2004
- Registry last updated
- Jan 15, 2010
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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