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

StatusRecruiting
PhasePhase 2
SponsorTakeda
Started

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Record History

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  1. Enrollment increased: 160 → 210 participants
    • Eligibility criteria expanded, about 142 words
    • Secondary endpoints: details revised at 5 of 12 entries
    • Site details revised at 5 of 53 sites
  2. Trial sites expanded: 47 → 53 locationsv16
  3. Study sites: 48 to 47v15
  4. Study sites: 43 to 48v14
  5. Primary endpoint revisedv13 Show 8 more changesShow less
    • Enrollment target: 140 to 160
    • Study completion date: Oct 30, 2030 to Oct 30, 2031
    • Interventions: KER-050 (Drug) to Elritercept (Drug)
    • Eligibility criteria expanded, about 2,416 words
    • Secondary endpoints: 10 to 12
    • Study description shortened, about 29 words
    • Study arms: 6 to 13
    • Study title expanded, about 2 words
Show 11 earlier versionsHide 11 earlier versions
  1. Lead sponsor: Keros Therapeutics, Inc. to Takeda
    • Primary completion date: Jun 30, 2025 to Oct 30, 2029
    • Study completion date: Nov 30, 2025 to Oct 30, 2030
    v12
  2. Site details revised at 1 of 43 sitesv11
  3. Study sites: 42 to 43v10
  4. Study sites: 41 to 42v9
  5. Site details revised at 2 of 41 sitesv8
  6. Enrollment target: 110 to 140
    • Study sites: 24 to 41
    • Secondary endpoints: 8 to 10
    • Eligibility criteria shortened, about 2 words
    v7
  7. Study sites: 19 to 24v6
  8. Study sites: 13 to 19v5
  9. Enrollment target: 54 to 110v4 Show 6 more changesShow less
    • Primary completion date: Jan 31, 2022 to Jun 30, 2025
    • Study completion date: Jul 31, 2022 to Nov 30, 2025
    • Eligibility criteria shortened, about 21 words
    • Secondary endpoints: details revised at 8 of 8 entries
    • Study sites revised (13)
    • Study arms: 5 to 6
  10. Study sites: 1 to 13
    • Start date changed from estimate of Sep 15, 2020 to Aug 19, 2020
    • Eligibility criteria revised
    v3
  11. Secondary endpoints revised (8)
    • Study arms: 1 to 5
    • Study description expanded, about 4 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 learn how safe elritercept is and how well adults with anemia associated with lower-risk MDS tolerate treatment with different doses of elritercept. Other aims are to learn how safe elritercept is by looking at how many participants have MDS that worsens during the study and learn about the effects of elritercept on anemia linked to MDS. The study will also look to learn how elritercept affects the production of healthy RBCs.
Trial Details
NCT Number NCT04419649
Lead Sponsor Takeda
Conditions
(from sponsor)		 Myelodysplastic Syndromes, Cytopenia
Related terms Cytopenia, Myelodysplastic Syndromes
Enrollment 210 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov