A Study to Investigate the Efficacy and Safety of Roxadustat (FG-4592) for Treating Anemia in Participants With Myelodysplastic Syndromes (MDS)

Sponsor
Kyntra Bio
Study ID
NCT07722988
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Myelodysplastic Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Roxadustat — DRUG
    Roxadustat will be administered per schedule specified in the arm description.
  • Placebo — DRUG
    Placebo matching to roxadustat will be administered per schedule specified in the arm description.

Study Details

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).

Key Dates

First listed
Jul 23, 2026
Start date
Apr 30, 2027
Status verified
Jul 2026
Primary completion
Sep 30, 2030
Completion
Dec 31, 2032

Study Design

Enrollment
201 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Roxadustat
    Participants will receive roxadustat, administered orally 3 times per week (TIW).
  • Placebo Comparator: Placebo
    Participants will receive placebo matching to roxadustat, administered orally TIW.

Primary Outcome Measure

Percentage of Participants With Red Blood Cell-transfusion Independence (RBC-TI) Over Any Consecutive 56-day Period [ Time Frame: Week 1 through Week 24 ]

Central Contacts

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