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Not yet recruiting NCT07722988

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

Phase III Interventional Myelodysplastic Syndromes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Roxadustat, Placebo.
Who it may be relevant to
Registry conditions: Myelodysplastic Syndromes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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).

Interventions

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

Primary outcome measures

  • 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 outcome measures (4)
  • 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)]
  • 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)]
  • 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)]
  • 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)]

Eligibility criteria

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07722988 · FGCL-4592-115

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗