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.
Belatacept in Heart Transplantation
At a glance
Conditions
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.
Study leadership
- 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
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 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