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A Study to Investigate the Efficacy and Safety of Roxadustat (FG-4592) for Treating Anemia in Participants With Myelodysplastic Syndromes (MDS)
Sponsor: Kyntra Bio
Summary
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).
Official title: 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 Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
201
Start Date
2027-04
Completion Date
2032-12
Last Updated
2026-07-23
Healthy Volunteers
No
Conditions
Interventions
Roxadustat
Roxadustat will be administered per schedule specified in the arm description.
Placebo
Placebo matching to roxadustat will be administered per schedule specified in the arm description.