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Heart transplant patients may get safer Anti-Rejection option

NCT ID NCT04477629

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2020

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

  • Columbia University

    ACTIVE_NOT_RECRUITING

    New York, New York, 10032, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

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