Study #2017-0042
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)
Study Status
Open
Treatment Agent
Roxadustat (FG-4592)
Principal Investigator
Yesid Alvarado
Description
The goal of this clinical research study is to learn if roxadustat (also known as FG-4592) is safe and effective for treating anemia (not enough red blood cells) in patients with myelodysplastic syndrome (MDS). In this study, roxadustat will be compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect. There are 2 parts to this study. In Part 1, all participants will receive the study drug. In Part 2, neither participants nor the study staff will not know if you are receiving placebo or the study drug.
General Information
Disease Group: Malignant neoplasms stated as primary lymphoid haematopoietic
Treatment Agent: Roxadustat (FG-4592)
Treatment Location: Both at MD Anderson & Other Sites
Sponsor: FibroGen Inc
Study Status
IRB Review and Approval Date: 11/29/2017
Recruitment Status: Open
Projected Accrual: 184
Resources and Links
Information and next steps
Disease:
Malignant neoplasms stated as primary lymphoid haematopoietic
Study phase:
Phase III
Physician name:
Yesid Alvarado
Department:
Leukemia
For general questions about clinical trials:
1-877-632-6789