FGCL-4592-082 (FL)
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 treatments
- Arm 1: FG-4592
- Arm 2: placebo
Inclusion criteria
- Diagnosis of primary MDS classified as very low, low or intermediate risk with <5% blasts.
- RBC transfusion of either 2-4 pRBC units over the 8 weeks prior to randomization or 1 pRBC in two consecutive periods of 8 weeks within the 16 weeks prior to randomization
- No restriction on prior use of ESAs, except no ESA use within 8 weeks prior to registration/randomization
- Pre-transfusion hemoglobin of <= 10 g/dL,
- ECOG of 0-2 at screen
Exclusion criteria
- Diagnosis of secondary MDS
- Significant myelofibrosis (>2+fibrosis)
- MDS associated with 5q(del) abnormality
- Screen serum erythropoietin level > 400 mIU/mL,
- Clinically significant anemia due to non-MDS etiologies
Participating sites
- Cliniques Universitaires Saint-Luc