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NCT06478017 · ClinicalTrials.gov registry record · Phase 2
Belatacept in Heart Transplantation
A Phase 2 study of Heart Transplant, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
- 4
- Study locations
NCT06478017 is a Phase 2 study of Heart Transplant that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 66 participants, below the 8,525-participant average among 12 other Heart Transplant trials with a reported enrollment target (99% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT06478017, a Phase 2 study of Heart Transplant, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
- 4
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Prednisone
- DRUG Tacrolimus
- DRUG Belatacept
- DRUG Mycophenolate Mofetil/Sodium
Study Locations (4)
California
- Cedars Sinai Heart Institute/ Cedars Sinai Medical (Site # 71146) - Los Angeles
Florida
- Tampa General Hospital (Site # 71150) - Tampa
New York
- NYU Langone Health (Site # 71177) - New York
Utah
- University of Utah Medical Center (Site # 71126) - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2025-01-29 |
| Est. Completion | 2028-01-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06478017
The ClinicalTrials.gov registry entry for NCT06478017 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 8,525-participant average among 12 other Heart Transplant trials with a reported enrollment target (99% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Heart Transplant appearing as the primary indexed condition, and to 4 interventions - of which Prednisone is the first listed.
NCT06478017 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT06478017 about?
NCT06478017 is a clinical study titled "Belatacept in Heart Transplantation". 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 ...
What is the current status of trial NCT06478017?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2025-01-29. Estimated completion is 2028-01-31.
What conditions does trial NCT06478017 study?
This clinical trial studies the following conditions: Heart Transplant.
What interventions are being tested in trial NCT06478017?
The interventions under investigation include: Prednisone (DRUG), Tacrolimus (DRUG), Belatacept (DRUG), Mycophenolate Mofetil/Sodium (DRUG).
Who is sponsoring clinical trial NCT06478017?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06478017 being conducted?
This trial has 4 study locations across California, Florida, New York, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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