Actively Recruiting
Belatacept in De Novo Heart Transplantation - Pilot Study
Led by NYU Langone Health · Updated on 2025-12-04
12
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
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 mg/kg on day 1, 5, and at the end of weeks 2, 4, 8, and 12, followed by 5 mg/kg 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.
CONDITIONS
Brief Title
Belatacept in De Novo Heart Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or non-pregnant female, age 18 to 75 years
- Awaiting a primary heart transplant (listed for heart transplant only)
- Epstein-Barr virus (EBV) IgG seropositive
- Able to take oral medication and willing to follow the belatacept infusion schedule
- No prior desensitization therapy before transplant
- Up to date on vaccinations for hepatitis B, influenza, pneumococcal, haemophilus, varicella zoster virus, measles, mumps, rubella, and HPV if under 45 years
- Negative pregnancy test for females of childbearing potential
- Mechanical support or investigational drug trials ending at transplantation are allowed
- Negative virtual crossmatch
You will not qualify if you...
- Awaiting multiorgan transplant
- Estimated glomerular filtration rate (eGFR) below 45 ml/min/m2
- Prior organ transplant
- Currently treated with immunosuppressive therapies
- History of cytolytic therapy treatment
- Planned cytolytic therapy after transplant as induction
- Epstein-Barr virus (EBV) IgG seronegative
- Active or prior infections with HIV, Hepatitis B, or Hepatitis C
- Untreated latent or active tuberculosis
- History of central nervous system infection
- Active infections including viral, fungal, or mycobacterial except driveline infections
- Live vaccination within past 30 days
- Cancer within the last 5 years
- Previous alkylating agent or total lymphoid irradiation treatment
- Sensitized heart transplant candidates with panel-reactive antibodies over 50% or receiving desensitization
- Prior treatment with belatacept or abatacept
- Severe allergic reactions to monoclonal antibodies
- Treatment with DMARDs or biologics within past year
- Treatment with other investigational drugs at transplant time
- Use of calcineurin inhibitors other than tacrolimus expected after transplant
- Mechanical circulatory support over 72 hours post-transplant
- Need for high dose vasopressor support over 72 hours post-transplant
- Need or expected need for post-transplant dialysis
- Platelet count under 75,000/mm within 24 hours prior to transplant
- Absolute neutrophil count under 2000/mm3 within 24 hours prior to transplant
- Any other medical issues posing added risk or interfering with study participation as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 months after transplantation
Participants receive belatacept infusions along with a tacrolimus tapering regimen, mycophenolate mofetil, and corticosteroids as part of their post-heart transplant immunosuppression.
Multiple visits for infusions and monitoring over 18 months
Trial Site Locations
Total: 2 locations
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
2
Columbia University
New York, New York, United States, 10032
Active, Not Recruiting
Research Team
A
Andrea Kim
D
Dylan McDonald
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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