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)

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.

Disease Group: Malignant neoplasms stated as primary lymphoid haematopoietic

Treatment Agent: Roxadustat (FG-4592)

Treatment Location: Both at MDACC & and Other Sites

Sponsor: FibroGen Inc

IRB Review and Approval Date: 11/29/2017

Recruitment Status: Open

Projected Accrual: 184

Phone Number: 1-877-MDA-6789

clinicaltrials.gov NCT No: NCT03263091