Belatacept in De Novo Heart Transplantation
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Heart Transplantation
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Study population includes first-time Epstein-Barr virus (EBV) seropositive, male and non-pregnant female heart transplant recipients 18 years of age or older, who are able to provide written informed consent for the study.Masking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
Long-term outcomes after heart transplant remain suboptimal with renal failure and cardiac allograft vasculopathy contributing to morbidity and mortality. Belatacept is Food and Drug Administration (FDA) approved for use in kidney transplant recipients on the basis of two randomized controlled trial...
Long-term outcomes after heart transplant remain suboptimal with renal failure and cardiac allograft vasculopathy contributing to morbidity and mortality. Belatacept is Food and Drug Administration (FDA) approved for use in kidney transplant recipients on the basis of two randomized controlled trials, which demonstrated important renal sparing benefits, a reduction in de novo donor-specific antibodies (DSA), and improved long-term outcomes. In this study, ten (10) primary heart transplant recipients will receive belatacept in addition to mycophenolate mofetil, corticosteroids, and a tacrolimus tapering regimen.
Tracking Information
- NCT #
- NCT04477629
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Principal Investigator: Marlena V. Habal, MD Columbia University
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