A Study to Investigate the Efficacy and Safety of Roxadustat (FG-4592) for Treating Anemia in Participants With Myelodysplastic Syndromes (MDS) | NCT07722988

NCT07722988

Overview

NCT ID: NCT07722988
Lead Sponsor: Kyntra BioINDUSTRY
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
Brief 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: Myelodysplastic Syndromes
Interventions: Roxadustat

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.