Belatacept in De Novo Heart Transplantation (NCT04477629)
Belatacept in De Novo Heart Transplantation - Pilot Study
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to determine if Belatacept is safe to give to adult heart transplant recipients. Belatacept (NULOJIX) is an anti-rejection medication that is available through a prescription from a doctor. In this research study, belatacept is being used in an investigational manner (not for the purpose that it is approved for).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (29 items).
Location: NYU Langone Health — New York, New York
Age range: 18 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck 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).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Candidates awaiting multiorgan transplant
- Estimated glomerular filtration rate (eGFR) \< 45 ml/min/m2
- Candidates with prior organ transplant
- Candidates actively being treated with immunosuppressive therapies
- Candidates who have a history of treatment with cytolytic therapy (e.g. anti-thymocyte globulin)
- Candidates who are intended to be treated with cytolytic therapy in the post-transplant period as induction therapy
- EBV (IgG) seronegative
- Active or prior infection with human immunodeficiency virus (HIV), Hepatitis C (HCV), Hepatitis B (HBV)
- Untreated latent tuberculosis (TB)
- 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
- Prior history of active tuberculosis
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (2 Sites)
- NYU Langone Health — New York, New York
- Columbia University — New York, New York
📞 Contact the Study Coordinator
Phone: (646) 457-0987
Email: Andrea.Kim@nyulangone.org
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.
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Explore by condition: All Heart Transplantation clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.