Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Amgen
Treatments:
Darbepoetin alfa
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