Study Enrollment

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Clinical Trial

FGCL-4592-082: A Phase 3 Randomized Double-Blind Placebo-Controlled Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients with Lower Risk Myelodysplastic Syndrome (MDS) with Low Red Blood Cell (RBC) Transfusion Burden (LTB)

This is a research study to test a new drug called roxadustat (also known as FG-4592) that is not approved by the Food and Drug Administration (FDA) to treat anemia (not enough red blood cells) in people diagnosed with lower risk myelodysplastic syndrome (MDS) (a rare disorder in which your bone marrow does not make enough healthy blood cells). We are looking to test the safety of the study drug, how much of the study drug is in your body based on what dose you get, how the study drug works on your cancer, and to find the appropriate dose of this study drug to use in this and other future studies.

Eligibility Criteria

  • Male or female, aged 18 years or older Subjects with confirmed relapsed/refractory acute myeloid leukemia (AML) or another cancer of the bone marrow, for example, myeloid neoplasms Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Contact Information

    Kelly Jenkins, RN, MSN, CNL

    (706) 721-1206