Belatacept in Heart Transplantation (NCT06478017)

🧪 Interventions in This Study

• Belatacept (DRUG)
• Tacrolimus (DRUG)
• Mycophenolate Mofetil/Sodium (DRUG)
• Prednisone (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Study entry
2. Subject must be able to understand the purpose of the study and be willing to participate and provide written consent
3. Recipient of a primary heart transplant (heart transplant only)
4. Epstein-Barr Virus (EBV) seropositive (VCA IgG, EBNA IgG). If EBNA is not available, enrollment may proceed but the result must be available prior to randomization.
5. Agreement to use contraception; according to the Food and Drug Administration (FDA) Office of Women's Health (http://www.fda.gov/birthcontrol), there are a number of birth control methods that are more than 80% effective. Female participants of child-bearing potential must consult with their physician and determine the most suitable method(s) from this list to be used for the duration of the study
6. In the absence of a contraindication, vaccinations must be up to date per the Division of Allergy, Immunology, and Transplantation (DAIT) Vaccination Guidance for Patients in Transplant Trials (niaidtransplantstudies.org)
7. Mechanical support or investigational drug trials where the intervention ends at the time of transplantation are permitted. Randomization
8. Recipient of a primary heart transplant
9. No desensitization therapy prior to transplant
10. Negative crossmatch actual or virtual, on the most recent sera as determined by the participating study center
11. Female subjects of childbearing potential must have a negative pregnancy test (serum or urine) prior to randomization
12. Agreement to use contraception; according to the FDA Office of Women's Health (http://www.fda.gov/birthcontrol), there are a number of birth control methods that are more than 80% effective. Female participants of child-bearing potential must consult with their physician and determine the most suitable method(s) from this list to be used for the duration of the study. Those who choose oral contraception must agree to use a second form of contraception after administration of study drug for a period of 1 year after the last dose of study drug

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (6 Sites)

• Cedars Sinai Heart Institute/ Cedars Sinai Medical (Site # 71146) — Los Angeles, California
• Tampa General Hospital (Site # 71150) — Tampa, Florida
• Emory University Hospital (Site #: 71103) — Atlanta, Georgia
• St. Luke's Hospital of Kansas City — Kansas City, Missouri
• NYU Langone Health (Site # 71177) — New York, New York
• University of Utah Medical Center (Site # 71126) — Salt Lake City, Utah

📞 Contact the Study Coordinator

Phone: (301) 706-9137

Email: ymorrison@niaid.nih.gov

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Heart Transplant

• XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP) — La Jolla, California
• US National OCS Heart Perfusion (OHP) Registry — Phoenix, Arizona
• Randomized Trial of SGLT2i in Heart Transplant Recipients — Palo Alto, California
• OCS DCD Heart + CAP Continued Follow-Up — La Jolla, California
• Non-invasive Prediction of EArly Cardiac rEjection — Little Rock, Arkansas

Explore by condition: All Heart Transplant clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.