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NCT07722988Not yet recruitingPhase 3

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

Source: ClinicalTrials.gov · Last updated 23 Jul 2026

Brief summary (registry, in English)

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).

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
201 (estimated)
First submitted
20 Jul 2026
Start date
Apr 2027
Primary completion date
Sept 2030
Lead sponsor
Kyntra Bio
NCT number
NCT07722988

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 201
  • From Apr 2027 to the primary completion date, Sept 2030
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior allogeneic or autologous stem cell transplant
  • Major surgery within 8 weeks prior to randomization.
    • Note: Other protocol-defined inclusion and exclusion criteria may apply.

Other illness

  • Participant has any significant medical illness or is considered vulnerable by local regulations

Other

  • Pregnant or breastfeeding females

Who the study is looking for

  • 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).
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.