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 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.

NCT Number	NCT06478017
Lead Sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Conditions	Heart Transplant
Enrollment	66 participants
Start Date	2025-01-29
Primary Completion	2028-01-31 (estimated)
Study Completion	2028-01-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-22