Condition: Heart Transplant · Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
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.
This description comes directly from the study's public registry record.
Yvonne Morrison · 301-706-9137 · ymorrison@niaid.nih.gov
Jaclyn Evans · 240-669-5470 · Jaclyn.evans@nih.gov
Always discuss trial participation with your own doctor first.
| Cedars Sinai Heart Institute/ Cedars Sinai Medical (Site # 71146) | Los Angeles, California, United States | Recruiting |
| Tampa General Hospital (Site # 71150) | Tampa, Florida, United States | Recruiting |
| Emory University Hospital (Site #: 71103) | Atlanta, Georgia, United States | Recruiting |
| St. Luke's Hospital of Kansas City | Kansas City, Missouri, United States | Recruiting |
| NYU Langone Health (Site # 71177) | New York, New York, United States | Recruiting |
| University of Utah Medical Center (Site # 71126) | Salt Lake City, Utah, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06478017