Using Belatacept for Heart Transplant Recipients
Belatacept in De Novo Heart Transplantation - Pilot Study
This study is testing if the medication Belatacept can safely help adults who have just received a heart transplant by improving their long-term health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT04477629 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety of Belatacept, an anti-rejection medication, in adult patients receiving a primary heart transplant. Participants will receive Belatacept alongside mycophenolate mofetil, corticosteroids, and a tapering regimen of tacrolimus. The study seeks to improve long-term outcomes for heart transplant recipients, addressing issues like renal failure and cardiac allograft vasculopathy. A total of ten primary heart transplant recipients will be enrolled to assess the efficacy and safety of this investigational use of Belatacept.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 who are awaiting a primary heart transplant and are Epstein-Barr virus IgG seropositive.
Not a fit: Patients awaiting multiorgan transplants or those with significant renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved long-term outcomes and reduced complications for heart transplant recipients.
How similar studies have performed: Other studies have shown success with Belatacept in kidney transplantation, but its use in heart transplantation is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or non-pregnant female, age ≥18 to ≤75 years 2. Awaiting a primary heart transplant (listed for heart transplant only) 3. Epstein-Barr virus (EBV) IgG seropositive 4. Able to take oral medication and willing to adhere to the belatacept infusion regimen 5. No desensitization therapy prior to transplant 6. Vaccinations should be up to date for hepatitis B, influenza pneumococcal, haemophilus, varicella zoster virus (VZV), measles, mumps and rubella (MMR), and Human Papilloma Virus (HPV) (for participants \< 45 years of age) when available 7. Female subjects of childbearing potential must have a negative pregnancy test (serum or urine) prior to randomization 8. Mechanical support or investigational drug trials where the intervention ends at the time of transplantation are permitted 9. Negative virtual crossmatch Exclusion Criteria: 1. Candidates awaiting multiorgan transplant 2. Estimated glomerular filtration rate (eGFR) \< 45 ml/min/m2 3. Candidates with prior organ transplant 4. Candidates actively being treated with immunosuppressive therapies 5. Candidates who have a history of treatment with cytolytic therapy (e.g. anti-thymocyte globulin) 6. Candidates who are intended to be treated with cytolytic therapy in the post-transplant period as induction therapy 7. EBV (IgG) seronegative 8. Active or prior infection with human immunodeficiency virus (HIV), Hepatitis C (HCV), Hepatitis B (HBV) 9. Untreated latent tuberculosis (TB) 10. 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 11. Prior history of active tuberculosis 12. Prior history of central nervous system infection 13. Known active current viral, fungal, mycobacterial, or other infections excluding driveline infections - potential participants from endemic areas will additionally be screened for histoplasmosis, blastomycosis, coccidioidomycosis, and strongyloidiasis 14. Vaccination with a live vaccine within the past 30 days 15. Malignancy within the last 5 years 16. Any previous treatment with alkylating agents or total lymphoid irradiation 17. Sensitized heart transplant candidates with panel-reactive antibodies (PRA) \>50% or those receiving desensitization treatment 18. Prior treatment with belatacept or abatacept 19. History of severe allergic anaphylactic reactions to humanized or murine monoclonal antibodies 20. Treatment with a disease modifying anti-rheumatic drug (DMARD) or other biologic agent (monoclonal antibody) within the past year 21. Treatment with another investigational drug or other intervention at the time of transplant (excluding device or intervention mechanical support or investigational drug trials where the intervention ends at the time of transplant) 22. Potential candidates for whom a calcineurin inhibitor other than tacrolimus (Prograf®) is anticipated after transplant. If during the course of the study, a participant is transitioned to another calcineurin inhibitor due to side effects or inability to achieve stable therapeutic trough levels, they may continue in the study at the discretion of the investigator 23. Any potential participant who remains on mechanical circulatory support for \> 72 hours post-transplant will be excluded from the study 24. The need for ongoing high dose vasopressor support \> 72 hours post-transplant 25. The need or anticipated need for post-transplant dialysis 26. Platelet count \<75,000/mm (within 24 hours prior to transplant) 27. Absolute neutrophil count (ANC) of less than 2000/mm3 within 24 hours prior to transplant 28. Any past or current medical problems or findings on history, physical examination, or laboratory testing, not listed above, that in the opinion of the investigator, may pose additional risk to participation, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of study results
Where this trial is running
New York, New York and 1 other locations
- NYU Langone Health — New York, New York, United States (Recruiting)
- Columbia University — New York, New York, United States (Active_not_recruiting)
Study contacts
- Principal investigator: Marlena V. Habal, MD — NYU Langone Health
- Study coordinator: Andrea Kim
- Email: Andrea.Kim@nyulangone.org
- Phone: 646-457-0987
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.