Heart transplant patients may get safer Anti-Rejection option
NCT ID NCT04477629
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether belatacept, an anti-rejection medication, is safe for adults who have just received a new heart. About 12 participants will receive the drug and be monitored for serious complications like rejection, infection, or organ failure. The goal is to find a better way to prevent the body from attacking the new heart.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2020
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or non-pregnant female, age ≥18 to ≤75 years 2. Awaiting a primary heart transplant (listed for heart transplant only) 3. Epstein-Barr virus (EBV) IgG seropositive 4. Able to take oral medication and willing to adhere to the belatacept infusion regimen 5. No desensitization therapy prior to transplant 6. Vaccinations should be up to date for hepatitis B, influenza pneumococcal, haemophilus, varicella zoster virus (VZV), measles, mumps and rubella (MMR), and Human Papilloma Virus (HPV) (for participants \< 45 years of age) when available 7. Female subjects of childbearing potential must have a negative pregnancy test (serum or urine) prior to randomization 8. Mechanical support or investigational drug trials where the intervention ends at the time of transplantation are permitted 9. Negative virtual crossmatch Exclusion Criteria: 1. Candidates awaiting multiorgan transplant 2. Estimated glomerular filtration rate (eGFR) \< 45 ml/min/m2 3. Candidates with prior organ transplant 4. Candidates actively being treated with immunosuppressive therapies 5. Candidates who have a history of treatment with cytolytic therapy (e.g. anti-thymocyte globulin) 6. Candidates who are intended to be treated with cytolytic therapy in the post-transplant period as induction therapy 7. EBV (IgG) seronegative 8. Active or prior infection with human immunodeficiency virus (HIV), Hepatitis C (HCV), Hepatitis B (HBV) 9. Untreated latent tuberculosis (TB) 10. All potential candidates will be screened prior to enrolment for a history of tuberculosis (chest radiograph and tuberculosis-Interferon Gamma Release Assay (TB-IGRA) or tuberculin skin tests (TST)). Potential candidates with latent TB must be treated prior to study enrolment 11. Prior history of active tuberculosis 12. Prior history of central nervous system infection 13. Known active current viral, fungal, mycobacterial, or other infections excluding driveline infections - potential participants from endemic areas will additionally be screened for histoplasmosis, blastomycosis, coccidioidomycosis, and strongyloidiasis 14. Vaccination with a live vaccine within the past 30 days 15. Malignancy within the last 5 years 16. Any previous treatment with alkylating agents or total lymphoid irradiation 17. Sensitized heart transplant candidates with panel-reactive antibodies (PRA) \>50% or those receiving desensitization treatment 18. Prior treatment with belatacept or abatacept 19. History of severe allergic anaphylactic reactions to humanized or murine monoclonal antibodies 20. Treatment with a disease modifying anti-rheumatic drug (DMARD) or other biologic agent (monoclonal antibody) within the past year 21. Treatment with another investigational drug or other intervention at the time of transplant (excluding device or intervention mechanical support or investigational drug trials where the intervention ends at the time of transplant) 22. Potential candidates for whom a calcineurin inhibitor other than tacrolimus (Prograf®) is anticipated after transplant. If during the course of the study, a participant is transitioned to another calcineurin inhibitor due to side effects or inability to achieve stable therapeutic trough levels, they may continue in the study at the discretion of the investigator 23. Any potential participant who remains on mechanical circulatory support for \> 72 hours post-transplant will be excluded from the study 24. The need for ongoing high dose vasopressor support \> 72 hours post-transplant 25. The need or anticipated need for post-transplant dialysis 26. Platelet count \<75,000/mm (within 24 hours prior to transplant) 27. Absolute neutrophil count (ANC) of less than 2000/mm3 within 24 hours prior to transplant 28. Any past or current medical problems or findings on history, physical examination, or laboratory testing, not listed above, that in the opinion of the investigator, may pose additional risk to participation, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of study results
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Columbia University
ACTIVE_NOT_RECRUITINGNew York, New York, 10032, United States
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NYU Langone Health
RECRUITINGNew York, New York, 10016, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Thymus cells may teach a new heart to be left alone
- Can a new care pathway speed up advanced heart failure decisions?
- Can a transition program keep young heart transplant patients on track?
- New study aims to spot heart transplant rejection without a biopsy
- Simple saltwater solution may shield kidneys after heart transplant
- Blood test may replace painful heart biopsies for transplant patients