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Belatacept in Heart Transplantation

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 1 of 1 entry Study sites: 6 to 8 · Interventions: Belatacept (Drug), Mycophenolate Mofetil/Sodium (Drug), Prednisone (Drug), Tacrolimus (Drug) to Belatacept (Drug), Mycophenolate Mofetil/Sodium (Drug), Prednisone (Drug), Tacrolimus (Drug) · Eligibility criteria expanded, about 30 words · 1 more Show 4 more changesShow less
    • Study sites: 6 to 8
    • Interventions: Belatacept (Drug), Mycophenolate Mofetil/Sodium (Drug), Prednisone (Drug), Tacrolimus (Drug) to Belatacept (Drug), Mycophenolate Mofetil/Sodium (Drug), Prednisone (Drug), Tacrolimus (Drug)
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: details revised at 10 of 23 entries
  2. Study sites: 5 to 6v12
  3. Study sites: 4 to 5v11
  4. Site contacts updated at 1 of 4 sitesv10
  5. Site contacts updated at 1 of 4 sitesv9
Show 7 earlier versionsHide 7 earlier versions
  1. Eligibility criteria expanded, about 364 wordsv8 See this version in full on ClinicalTrials.gov ↗
  2. Site details revised at 1 of 4 sitesv7
  3. Start date changed from estimate of Jan 15, 2025 to Jan 29, 2025 Site details revised at 2 of 4 sitesv6 Show 1 more changeShow less
    • Site details revised at 2 of 4 sites
  4. Start date: Nov 18, 2024 to Jan 15, 2025 Eligibility criteria revised · Secondary endpoints revised (23)v5 Show 2 more changesShow less
    • Eligibility criteria revised
    • Secondary endpoints revised (23)

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status: Not Yet Recruiting to Recruiting Start date: Sep 27, 2024 to Nov 18, 2024 · Site details revised at 4 of 4 sitesv4 Show 2 more changesShow less
    • Start date: Sep 27, 2024 to Nov 18, 2024
    • Site details revised at 4 of 4 sites
  6. Start date: Sep 3, 2024 to Sep 27, 2024v3
  7. Start date: Jul 1, 2024 to Sep 3, 2024 Secondary endpoints revised (23)v2 Show 1 more changeShow less
    • Secondary endpoints revised (23)

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
This is a phase 2, prospective, multi-center, open-label clinical trial. Sixty-six (66) primary heart transplant recipients will be randomized (1:2) to receive either standard-of-care, tacrolimus-based immunosuppression, or a belatacept-based regimen with gradual tacrolimus withdrawal over 9-months post-transplant. Both study arms will receive CellCept® (mycophenolate mofetil- MMF) or Myfortic® (mycophenolate sodium). Corticosteroids will be continued throughout the study in the belatacept arm. The primary objective is to evaluate whether NULOJIX® (belatacept), when implemented with gradual tacrolimus withdrawal over 9 months, is safe with respect to preventing the composite endpoint of acute cellular rejection (ACR) \>= International Society of Heart and Lung Transplantation (ISHLT) 2R, hemodynamic compromise rejection in the absence of a biopsy or histological rejection, re-transplantation, and death at 18 months post-transplant.
Trial Details
NCT Number NCT06478017
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Heart Transplant
Enrollment 66 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov