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