Belatacept in Heart Transplant Patients
This study is looking at whether Belatacept (NULOJIX), an anti-rejection medicine, is safe for adults who have recently received a heart transplant. Belatacept is approved for kidney transplants, but this study is testing its use in heart transplant patients. You would also receive standard anti-rejection medications like Tacrolimus, Mycophenolate Mofetil, and Corticosteroids. Researchers will be watching for major problems with the transplanted heart for up to 18 months. To join, you must be between 18 and 75 years old, waiting for your first heart transplant, and have tested positive for Epstein-Barr virus (EBV) IgG. The study plans to enroll 12 participants.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 12 participants.
- What's involved
- You would receive Belatacept infusions on a specific schedule, along with other anti-rejection medications. You would also need to take oral medications.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will follow participants for up to 18 months after transplantation to measure major graft-related adverse events.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Belatacept in De Novo Heart Transplantation
At a glance
Conditions
NCT04477629
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
NYU Langone Health
New York, New Yorkstudy coordinator listed
Recruiting
Columbia University
New York, New Yorkno site contact published
Active, not recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Marlena V. Habal, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Number of Major Graft-Related Adverse EventsUp to 18 months after transplantation
Adverse events that will be counted in the total number include: Episodes of acute cellular rejection ≥ 2R/3A, antibody mediated rejection (AMR) ≥ International Society of Heart and Lung Transplantation (ISHLT) AMR 1, hemodynamically compromised rejection, development of cardiac allograft vasculopathy, graft failure occurring ≥ 14 days post-transplant, the need for re-transplant, serious infection requiring inpatient intravenous therapies, post-transplant lymphoproliferative disorder (PTLD), or death.