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)

Study treatment

• Experimental arm: FG-4592 (three times a week)
• Placebo arm: placebo (three times a week)

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
• pre-transfusion hemoglobin of <= 10 g/dL
• ECOG 0-2

Exclusion criteria

• Diagnosis of secondary MDS
• Significant myelofibrosis
• MDS associated with 5q(del) abnormality
• Screen serum erythropoietin level > 400 mlU/Ml

Participating sites

• CHU UCL Cliniques Universitaires St-Luc