A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants with Very Low-, Low-, or Intermediate-Risk Myelodysplastic Syndromes (MDS) (RENEW)
Trial status: Authorised
1. Proportion of participants achieving TI for ≥ 24 weeks from baseline through week 48, 2. Proportion of participants with HTB achieving TI for ≥ 8 weeks from baseline through week 24, 3. Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), 4. Change from baseline in clinical laboratory values, vital signs, and electrocardiograms (ECGs)
Proportion of participants achieving transfusion independence (TI) for ≥ 8 weeks from baseline through week 24
Description
1. Proportion of participants achieving TI for ≥ 24 weeks from baseline through week 48, 2. Proportion of participants with HTB achieving TI for ≥ 8 weeks from baseline through week 24, 3. Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), 4. Change from baseline in clinical laboratory values, vital signs, and electrocardiograms (ECGs)
Who can participate
Age group: 65+ years, 18-64 years
Gender: Female, Male
Target enrollment: 82 participants
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