Actively Recruiting
Belatacept in Heart Transplantation
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-07
66
Participants Needed
5
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase 2, prospective, multi-center, open-label clinical trial. Sixty-six (66) primary heart transplant recipients will be randomized (1:2) to receive either standard-of-care, tacrolimus-based immunosuppression, or a belatacept-based regimen with gradual tacrolimus withdrawal over 9-months post-transplant. Both study arms will receive CellCept® (mycophenolate mofetil- MMF) or Myfortic® (mycophenolate sodium). Corticosteroids will be continued throughout the study in the belatacept arm. The primary objective is to evaluate whether NULOJIX® (belatacept), when implemented with gradual tacrolimus withdrawal over 9 months, is safe with respect to preventing the composite endpoint of acute cellular rejection (ACR) \>= International Society of Heart and Lung Transplantation (ISHLT) 2R, hemodynamic compromise rejection in the absence of a biopsy or histological rejection, re-transplantation, and death at 18 months post-transplant.
CONDITIONS
Official Title
Belatacept in Heart Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand the study and willing to provide written consent
- Recipient of a primary heart transplant only
- Epstein-Barr Virus (EBV) seropositive (VCA IgG, EBNA IgG). If EBNA not available, result must be available before randomization
- Agreement to use contraception; females of child-bearing potential must select suitable birth control for the study duration
- Vaccinations must be up to date per transplant vaccination guidelines unless contraindicated
- Mechanical support or investigational drug trials ending at transplant are allowed
- No desensitization therapy prior to transplant
- Negative crossmatch on most recent sera
- Female participants of childbearing potential must have a negative pregnancy test before randomization
- Pre-transplant estimated glomerular filtration rate (eGFR) over 30 ml/min/1.73m² or expected renal recovery if lower
- Dialysis patients at randomization or expected to require dialysis are excluded
You will not qualify if you...
- Candidate for multiple organ or tissue transplants
- Prior history of any organ, tissue, or cellular transplant
- Currently breastfeeding or planning pregnancy during study follow-up
- History of severe allergic or anaphylactic reactions to monoclonal antibodies
- Known allergy to belatacept (NULOJIX) or abatacept (ORENCIA)
- Previous treatment with belatacept or abatacept
- EBV seronegative or indeterminant
- HIV positive
- Hepatitis B surface antigen or core antibody positive
- Hepatitis C antibody and PCR positive or transplant from HCV NAT positive donor
- Active tuberculosis in past 2 years or untreated latent TB
- Positive serology or history of Chagas disease
- Residents or prior residents in endemic areas for coccidiomycosis without prophylaxis
- Chest imaging suggestive of fungal infection without alternative cause
- Active viral, fungal, mycobacterial, or other infections (except drive line infections)
- Low white blood cell or neutrophil counts likely to require immunosuppression reduction
- History of active inflammatory bowel disease, chronic diarrhea, or malabsorption
- History of malignancy or AL amyloidosis
- Use or planned use of induction therapy or desensitization treatments around transplant
- Calculated panel reactive antibody (cPRA) over 50%
- Use of immunosuppressive biologics within 1 month prior to transplant
- Intent to use biologics not indicated by protocol during study
- Use of high dose intravenous immunoglobulin before or at transplant
- Severe hypogammaglobulinemia (<300 mg/dL)
- Receipt of live vaccine within 30 days prior to randomization
- Use of other investigational drugs after transplant
- Any medical condition that may increase risk or interfere with study participation as judged by investigator
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Cedars Sinai Heart Institute/ Cedars Sinai Medical (Site # 71146)
Los Angeles, California, United States, 90048
Actively Recruiting
2
Tampa General Hospital (Site # 71150)
Tampa, Florida, United States, 33606
Actively Recruiting
3
St. Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Actively Recruiting
4
NYU Langone Health (Site # 71177)
New York, New York, United States, 10016
Actively Recruiting
5
University of Utah Medical Center (Site # 71126)
Salt Lake City, Utah, United States, 84132
Actively Recruiting
Research Team
Y
Yvonne Morrison
CONTACT
J
Jaclyn Evans
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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