Belatacept to reduce rejection and protect kidneys after a heart transplant
Safety and efficacy of Belatacept in heart transplantation
['FUNDING_U01'] · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · NIH-11326277
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
| Phase | ['FUNDING_U01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | NEW YORK UNIVERSITY SCHOOL OF MEDICINE (nih funded) |
| Locations | 1 site (NEW YORK, UNITED STATES) |
| Trial ID | NIH-11326277 on ClinicalTrials.gov |
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.
Who could benefit from this research
Good fit: Adults receiving their first heart transplant who can attend study visits and follow the planned immunosuppression changes are the intended participants.
Not a fit: People with contraindications to belatacept, uncontrolled infections, or other medical reasons that make changing immunosuppression unsafe may not receive benefit from this approach.
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 performed: 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, UNITED STATES
- 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
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 below.