Belatacept in De Novo Heart Transplantation

Status Recruiting

Clinical Trial Summary

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).

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

Heart Transplantation

Clinical Trial Details

NCT number	NCT04477629
Study type	Interventional
Source	NYU Langone Health
Contact	Andrea Kim
Phone	646-457-0987
Email	Andrea.Kim@nyulangone.org
Status	Recruiting
Phase	Phase 2
Start date	August 6, 2020
Completion date	February 2025

View Details

See also
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