Study of Belatacept to Prevent Rejection in Adults Undergoing First Heart Transplant

What this Trial Is About

Researchers are evaluating the safety of Belatacept, an anti-rejection medication, in adult patients who have received a heart transplant for the first time. The study aims to improve long-term outcomes after heart transplantation, focusing on reducing kidney failure and cardiac allograft vasculopathy, which contribute to illness and death. Belatacept is already FDA-approved for kidney transplant patients and is being studied here in heart transplant recipients. Participants in this pilot study will receive Belatacept intravenously starting with 10 mgkg on day 1, 5, and at the end of weeks 2, 4, 8, and 12, followed by 5 mgkg every 4 weeks. Alongside Belatacept, they will receive a tapering dose of tacrolimus, mycophenolate mofetil, and corticosteroids as part of the standard care after heart transplantation. The tacrolimus dose is carefully adjusted over several months, and other medications follow usual clinical dosing recommendations. Throughout the 18 months after transplantation, participants will be closely monitored for major graft-related adverse events. Researchers will assess kidney function through estimated glomerular filtration rate eGFR and check for the development of new donor-specific antibodies. Participants will have regular visits for assessments including blood tests and clinical evaluations to track their health and medication effects during the study period.

Belatacept in De Novo Heart Transplantation