A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions

StatusRecruiting
PhasePhase 3
SponsorTakeda
Started

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Record History

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  1. Trial sites expanded: 177 → 182 locations
    • Eligibility criteria expanded, about 194 words
    • Secondary endpoints: details revised at 1 of 4 entries
    • Study description shortened, about 3 words
  2. Study sites: 179 to 177v14
  3. Trial sites expanded: 155 → 179 locationsv13
  4. Study sites: 156 to 155v12
  5. Site details revised at 156 of 156 sitesv11
Show 9 earlier versionsHide 9 earlier versions
  1. Site details revised at 156 of 156 sitesv10
  2. Primary endpoint revisedv9 Show 9 more changesShow less
    • Study sites: 28 to 156
    • Primary completion date: May 2028 to May 1, 2028
    • Study completion date: May 2032 to May 1, 2032
    • Interventions: KER-050 (Biological), Placebo (Drug) to Elritercept (Drug), Placebo (Drug)
    • Eligibility criteria expanded, about 63 words
    • Secondary endpoints: 3 to 4
    • Study description expanded, about 7 words
    • Collaborators shortened, about 2 words
    • Study title expanded, about 2 words
  3. Lead sponsor: Keros Therapeutics, Inc. to Takeda
    • Start date changed from estimate of Jun 2025 to May 6, 2025
    v8
  4. Study sites: 6 to 28
    • Start date: May 2025 to Jun 2025
    v7
  5. Study sites: 5 to 6v6
  6. Start date: Mar 2025 to May 2025
    • Study sites: 2 to 5
    • Primary completion date: Mar 2028 to May 2028
    • Study completion date: Mar 2032 to May 2032
    v5
  7. Study sites: 1 to 2
    • Start date: Feb 2025 to Mar 2025
    v4
  8. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Mar 14, 2032 to Mar 2028
    • Start date: Dec 31, 2024 to Feb 2025
    • Study sites: 0 to 1
    • Study completion date: Mar 14, 2032 to Mar 2032
  9. Eligibility criteria expanded, about 538 words
    • Secondary endpoints expanded, about 48 words
    • Study description expanded, about 222 words
    • Collaborators expanded, about 2 words
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The main aim of this study is to find out how well elritercept works in lowering the need for RBC transfusions. Other aims are to learn how well elritercept works in reducing the need for RBC transfusions over longer periods of time or in adults with high transfusion needs. The study will also check on how safe elritercept is and how well it is tolerated.
Trial Details
NCT Number NCT06499285
Lead Sponsor Takeda
Conditions
(from sponsor)		 Myelodysplastic Syndromes
Related terms Anemia, Myelodysplastic Syndromes
Enrollment 225 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov