Belatacept to reduce rejection and protect kidneys after a heart transplant
Official title: Safety and efficacy of Belatacept in heart transplantation
Funded at New York University School of Medicine · NIH-11326277 · Data updated 2026-11-12
This trial will compare continuing tacrolimus to gradually switching to belatacept over nine months in people receiving a first-time heart transplant to lower rejection, prevent donor-specific antibodies, and protect kidney function.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | New York University School of Medicine NIH-funded |
| Lab location | 1 site (New York, United States) |
| Project start | June 6, 2023 |
| Project end | March 31, 2028 |
| Funding year | 2026 |
| Award (this year) | $2,042,672 |
| NIH project number | 5U01AI174997-04 |
| Project ID | NIH-11326277 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults receiving their first heart transplant who can attend study visits and follow the planned immunosuppression changes are the intended participants.
✕Less likely to help
People with contraindications to belatacept, uncontrolled infections, or other medical reasons that make changing immunosuppression unsafe may not receive benefit from this approach.
What this research studies
If you receive your first heart transplant, you would be randomly assigned to keep the usual tacrolimus-based drugs or to a plan that slowly stops tacrolimus over nine months and starts belatacept while continuing mycophenolate and prednisone. The team will monitor you with blood tests, antibody checks, and biopsies as needed to watch for rejection, donor-specific antibodies, and kidney function. The gradual withdrawal is designed to reduce early rejection risk while aiming to prevent long-term kidney damage linked to calcineurin inhibitors. The hope is to lower antibody-driven blood vessel disease in the new heart and improve long-term outcomes without causing more rejection.
Why it matters
Potential benefit: If successful, this approach could reduce harmful antibodies and kidney damage after heart transplant, potentially improving long-term graft and patient survival.
How similar studies have gone: Belatacept has improved kidney function and reduced donor-specific antibodies in kidney transplant trials, but its use in heart transplant recipients is newer and being formally tested.
Where this research is happening
-
New York University School of Medicine
New York, United States Active
Researchers
- Principal investigator: Habal, Marlena — New York University School of Medicine
- Study coordinator: Habal, Marlena
Related research
Other NIH-funded projects on the same topics.
-
Targeted immune treatments to protect donated hearts
This project develops ways to send immune-suppressing medicines directly to the lymph nodes and the transplanted heart to help people with heart transplants avoid rejection while reducing side effects.
-
IL-33 helps protect heart transplant patients from long-term rejection
This grant studies how a natural molecule called IL-33 may shield heart transplant patients from ongoing immune damage and chronic rejection.
-
Targeted mRNA delivery to improve heart transplants from donation after circulatory death
This grant tests a new mRNA delivery approach to help donor hearts from donors after circulatory death survive and function better after transplant.
-
Partial heart transplant to give growing heart valves to children
This work tries transplanting only the donor heart part that contains a valve so children can get a valve that grows with them.
-
Predicting Heart Transplant Rejection Risk Before Surgery
This research aims to find ways to predict which heart transplant patients might reject their new heart, helping doctors tailor their medication plans.
-
How IL-33 may protect transplanted hearts
This work looks at whether a natural protein called IL-33 can reduce inflammation and scarring after a heart transplant for transplant recipients.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.