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NCT Number: NCT07722988

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

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).

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Key information

Conditions

Myelodysplastic Syndromes Anemia Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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.

Note: Other protocol-defined inclusion and exclusion criteria may apply.

Treatment and study plan

Roxadustat

Drug

Roxadustat will be administered per schedule specified in the arm description.

Other names: FG-4592

Placebo

Drug

Placebo matching to roxadustat will be administered per schedule specified in the arm description.

Primary outcomes

  1. Percentage of Participants With Red Blood Cell-transfusion Independence (RBC-TI) Over Any Consecutive 56-day Period

    Time frame: Week 1 through Week 24

Secondary outcomes

  1. Percentage of Participants With RBC-TI Over Any Consecutive 84-day Period

    Time frame: Week 1 through Week 48 or end of treatment (EOT; up to 5 years)

  2. Percentage of Participants With RBC-TI Over Any Consecutive 112-day Period

    Time frame: Week 1 through Week 48 or EOT (up to 5 years)

  3. Percentage of Participants With ≥50% Reduction in Rate of Total Red Blood Cell (RBC) Units Transfused During a 16-week Period

    Time frame: Week 1 through Week 48 or EOT (up to 5 years)

  4. Percentage of Participants With RBC-TI Over Any Consecutive 168-day Period

    Time frame: Week 1 through Week 48 or EOT (up to 5 years)

Study contacts

Contact information is provided by the study sponsor or research team.

Javier Moreno

CONTACT

[email protected]

415-978-1466

Mairead Carney

CONTACT

[email protected]

415-978-1337

Sponsors and collaborators

Lead sponsor

Kyntra Bio

Industry

Registry information

Official study 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

Important dates

Study start
2027
Primary completion
2030
Study completion
2032
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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