Actively Recruiting
Belatacept in De Novo Heart Transplantation
Led by NYU Langone Health · Updated on 2025-12-04
12
Participants Needed
2
Research Sites
316 weeks
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
The purpose of this study is to determine if Belatacept is safe to give to adult heart transplant recipients. Belatacept (NULOJIX) is an anti-rejection medication that is available through a prescription from a doctor. In this research study, belatacept is being used in an investigational manner (not for the purpose that it is approved for).
CONDITIONS
Official Title
Belatacept in De Novo Heart Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or non-pregnant female aged 18 to 75 years
- Awaiting a primary heart transplant only
- Epstein-Barr virus (EBV) IgG seropositive
- Able to take oral medications and willing to follow belatacept infusion schedule
- No desensitization therapy before transplant
- Up to date vaccinations for hepatitis B, influenza, pneumococcal, haemophilus, varicella zoster virus, measles, mumps, rubella, and HPV (if under 45 years old)
- Negative pregnancy test for females of childbearing potential before randomization
- Mechanical support or investigational drug trials ending at transplant allowed
- Negative virtual crossmatch
You will not qualify if you...
- Awaiting multiorgan transplant
- Estimated glomerular filtration rate (eGFR) below 45 ml/min/m2
- Previous organ transplant
- Currently treated with immunosuppressive therapies
- History of treatment with cytolytic therapy (e.g., anti-thymocyte globulin)
- Planned cytolytic therapy as induction after transplant
- Epstein-Barr virus (EBV) IgG seronegative
- Active or prior HIV, Hepatitis C, or Hepatitis B infection
- Untreated latent tuberculosis
- History of active tuberculosis
- History of central nervous system infection
- Known active infections (viral, fungal, mycobacterial) excluding driveline infections; screening for certain fungal infections if from endemic areas
- Received live vaccine within 30 days
- Cancer within last 5 years
- Previous treatment with alkylating agents or total lymphoid irradiation
- Sensitized heart transplant candidates with panel-reactive antibodies over 50% or receiving desensitization
- Previous treatment with belatacept or abatacept
- History of severe allergic reactions to monoclonal antibodies
- Treatment with disease modifying anti-rheumatic drugs or monoclonal antibodies within past year
- Treatment with other investigational drugs at transplant (except specified exceptions)
- Expected use of calcineurin inhibitors other than tacrolimus after transplant, unless changed during study
- Mechanical circulatory support over 72 hours after transplant
- Need for high dose vasopressors over 72 hours after transplant
- Need or expected need for dialysis after transplant
- Platelet count below 75,000/mm within 24 hours before transplant
- Absolute neutrophil count below 2000/mm3 within 24 hours before transplant
- Any other medical problems posing risk or interfering with study according to investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
D
Dylan McDonald
CONTACT
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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