Belatacept in Heart Transplantation

This study is testing a new approach to prevent rejection after a heart transplant. It's comparing the standard treatment, which includes tacrolimus, with a regimen that uses belatacept (NULOJIX®) and gradually reduces tacrolimus over nine months. Both groups will also receive mycophenolate mofetil/sodium (CellCept® or Myfortic®). The main goal is to see if belatacept is safe and effective at preventing acute cellular rejection (ACR), which is when your body's immune system attacks the new heart, or other serious problems like re-transplantation or death. You may be able to join if you are between 18 and 71 years old, are receiving your first heart transplant, and have a specific virus called Epstein-Barr Virus (EBV) in your system. The study plans to enroll 66 participants.

Study design
This is a Phase 2, multi-center study where 66 heart transplant recipients will be randomly assigned to one of two treatment groups: standard care or a belatacept-based regimen.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the time they are randomly assigned to a treatment group until 18 months after their transplant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06478017

Belatacept in Heart Transplantation

Recruiting
PHASE2Ages 18–71InterventionalTreatment
National Institute of Allergy and Infectious Diseases (NIAID)
~66 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:BelataceptTacrolimusMycophenolate Mofetil/SodiumPrednisone

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of subjects who experience acute cellular rejection (ACR) >ISHLT 2R (local or core read), hemodynamic compromise (HDC) rejection in the absence of a biopsy or histological rejection, re-transplantation, or death as a composite endpoint.
Measured over From randomization to 18 months post-transplantation
Heart Transplant

NCT06478017

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cedars Sinai Heart Institute/ Cedars Sinai Medical (Site # 71146)

    Los Angeles, Californiastudy coordinator listed

    Recruiting

  • Emory University Hospital (Site #: 71103)

    Atlanta, Georgiastudy coordinator listed

    Recruiting

  • NYU Langone Health (Site # 71177)

    New York, New Yorkstudy coordinator listed

    Recruiting

  • St. Luke's Hospital of Kansas City

    Kansas City, Missouristudy coordinator listed

    Recruiting

  • Tampa General Hospital (Site # 71150)

    Tampa, Floridastudy coordinator listed

    Recruiting

  • University of Utah Medical Center (Site # 71126)

    Salt Lake City, Utahstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Joren C Madsen, MD, DPhil · STUDY_CHAIR · Massachusetts General Hospital
  • Jon A. Kobashigawa, MD · STUDY_CHAIR · Cedars-Sinai Medical Center
  • Marlena Habal, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health
  • Christian P. Larsen, MD, DPhil · STUDY_CHAIR · Emory University

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  • Proportion of subjects who experience acute cellular rejection (ACR) >ISHLT 2R (local or core read), hemodynamic compromise (HDC) rejection in the absence of a biopsy or histological rejection, re-transplantation, or death as a composite endpoint.From randomization to 18 months post-transplantation