Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
12 participants
INTERVENTIONAL
2020-08-06
2026-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Belatacept in Heart Transplantation
NCT06478017
Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation
NCT01436305
Belatacept (Nulojix) in Renal Transplant Recipient With Mild Immunologic Risk Factor: a Pilot Prospective Study.
NCT02738918
Belatacept to Prevent Organ Rejection in Kidney Transplant Patients
NCT00346151
Belatacept Pilot Study in Lung Transplantation Immunosuppression in Lung Transplantation
NCT03388008
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Belatacept
Participants will receive Belatacept along with an upfront tacrolimus taper Participants will also receive mycophenolate mofetil and corticosteroids are part of standard of care after heart transplant and will follow dosing recommendations as per standard clinical practice.
Belatacept
Belatacept will be given in the following way - 10mg/kg IV day 1, 5, end of weeks 2, 4, 8, 12 then 5mg/kg every 4 weeks.
Tacrolimus
Non-experimental: Tacrolimus will be given in the following way - trough level at month 1, 10-12ng/mL; month 2-3, 6-10ng/mL; month 4-6, 4-6ng/mL; months 7-9 taper off.
Mycophenolate Mofetil
Non-experimental: MMF is part of standard of care after heart transplant and will follow dosing recommendations as per standard clinical practice at 500-1500mg twice a day (BID) (dosed to tolerance and effect).
Corticosteroid
Non-experimental: CS is part of standard of care after heart transplant and will follow dosing recommendations as per standard clinical practice at a dose no less than 5mg/d.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Belatacept
Belatacept will be given in the following way - 10mg/kg IV day 1, 5, end of weeks 2, 4, 8, 12 then 5mg/kg every 4 weeks.
Tacrolimus
Non-experimental: Tacrolimus will be given in the following way - trough level at month 1, 10-12ng/mL; month 2-3, 6-10ng/mL; month 4-6, 4-6ng/mL; months 7-9 taper off.
Mycophenolate Mofetil
Non-experimental: MMF is part of standard of care after heart transplant and will follow dosing recommendations as per standard clinical practice at 500-1500mg twice a day (BID) (dosed to tolerance and effect).
Corticosteroid
Non-experimental: CS is part of standard of care after heart transplant and will follow dosing recommendations as per standard clinical practice at a dose no less than 5mg/d.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
NYU Langone Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marlena V. Habal, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
NYU Langone Health
New York, New York, United States
Columbia University
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
22-01135
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.