The study is designed to determine the efficacy and safety of roxadustat for the treatment of anemia due to very low, low, or intermediate risk MDS in participants with high transfusion burden (HTB).
Diagnosis of MDS according to World Health Organization (WHO) criteria confirmed by bone marrow aspirate and biopsy within 12 weeks before randomization.
Revised International Prognostic Scoring System (IPSS-R) very low, low, or intermediate risk MDS
HTB: Participants requiring ≥ 4 units of packed red blood cell (pRBC) in two consecutive 8-week periods prior to randomization
Refractory to, intolerant to, or ineligible for prior erythropoiesis-stimulating agents (ESAs).
Pregnant or breastfeeding females
Participant has any significant medical illness or is considered vulnerable by local regulations
Prior allogeneic or autologous stem cell transplant
Major surgery within 8 weeks prior to randomization.