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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)

NCT07722988 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2026-07-23

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Placebo

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

DRUG

Roxadustat

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

Sponsors & Collaborators

  • Kyntra Bio

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-04-30
Primary Completion
2030-09-30
Completion
2032-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07722988 on ClinicalTrials.gov