[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648595":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":31,"locations":30,"responsibleParty":41,"collaborators":30,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":30,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":30,"enrollmentInfo":52,"targetDuration":30,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":76,"whyStopped":30,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":30},{"fullName":5,"class":6},"Kyntra Bio","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Roxadustat","EXPERIMENTAL","Participants will receive roxadustat, administered orally 3 times per week (TIW).",[13],"Drug: Roxadustat",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants will receive placebo matching to roxadustat, administered orally TIW.",[19],"Drug: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Roxadustat will be administered per schedule specified in the arm description.",[9],[26],"FG-4592",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Placebo matching to roxadustat will be administered per schedule specified in the arm description.",[15],null,[32,37],{"name":33,"role":34,"phone":35,"phoneExt":30,"email":36},"Mairead Carney","CONTACT","415-978-1337","mcarney@kyntrabio.com",{"name":38,"role":34,"phone":39,"phoneExt":30,"email":40},"Javier Moreno","415-978-1466","jmoreno@kyntrabio.com",{"type":42,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100648595","phase-3-a-study-to-investigate-the-efficacy-and-safety-of-roxadustat-fg-4592-for-treating-anemia-in-participants-with-myelodysplastic-syndromes-mds-100648595",false,"NCT07722988","A Study to Investigate the Efficacy and Safety of Roxadustat (FG-4592) for Treating Anemia in Participants With Myelodysplastic Syndromes (MDS)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) in Participants With High Red Blood Cell Transfusion Burden","Key Inclusion Criteria:\n\n* Diagnosis of MDS according to World Health Organization (WHO) criteria confirmed by bone marrow aspirate and biopsy within 12 weeks before randomization.\n* Revised International Prognostic Scoring System (IPSS-R) very low, low, or intermediate risk MDS\n* HTB: Participants requiring ≥ 4 units of packed red blood cell (pRBC) in two consecutive 8-week periods prior to randomization\n* Refractory to, intolerant to, or ineligible for prior erythropoiesis-stimulating agents (ESAs).\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2\n\nKey Exclusion Criteria:\n\n* Pregnant or breastfeeding females\n* Participant has any significant medical illness or is considered vulnerable by local regulations\n* Prior allogeneic or autologous stem cell transplant\n* Major surgery within 8 weeks prior to randomization.\n\nNote: Other protocol-defined inclusion and exclusion criteria may apply.","ALL","18 Years",{"count":53,"type":54},201,"ESTIMATED","INTERVENTIONAL",[57],"PHASE3","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).",[60],"Myelodysplastic Syndromes",[9,26,62,63,64,65,66,67,68,69,70,71,5,72,73,74,75],"LR-MDS","MDS","Myelodysplastic syndromes","Oral","Transfusion","High transfusion burden","Anemia","Red blood cell","Transfusion independence","Hemoglobin","Kyntra","FibroGen","KYNB","ESA","NOT_YET_RECRUITING","2026-07-20",{"date":79,"type":80},"2026-07-23","ACTUAL",{"date":82,"type":54},"2027-04",{"date":84,"type":54},"2032-12",{"name":5,"class":6}]