Belatacept in De Novo Heart Transplantation
ConditionHeart Transplantation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNYU Langone Health
About this trial
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).
Eligibility criteria
Qualifiers
Male or non-pregnant female, age ≥18 to ≤75 years
Awaiting a primary heart transplant (listed for heart transplant only)
Epstein-Barr virus (EBV) IgG seropositive
Able to take oral medication and willing to adhere to the belatacept infusion regimen
Disqualifiers
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
Trial design
Treatments tested in this trial
- Belatacept
- Tacrolimus
- Mycophenolate Mofetil
- Corticosteroid
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
NYU Langone Health
Lead sponsor
Bristol-Myers Squibb
Collaborator
Source ClinicalTrials.gov