RecruitingPhase 2NCT06478017

Belatacept in Heart Transplantation

Belatacept With Delayed Tacrolimus Withdrawal Versus Standard-of-Care Tacrolimus in Heart Transplant Recipients (RTB-013)


Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

66 participants

Start Date

Jan 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase 2, prospective, multi-center, open-label clinical trial. Sixty-six (66) primary heart transplant recipients will be randomized (1:2) to receive either standard-of-care, tacrolimus-based immunosuppression, or a belatacept-based regimen with gradual tacrolimus withdrawal over 9-months post-transplant. Both study arms will receive CellCept® (mycophenolate mofetil- MMF) or Myfortic® (mycophenolate sodium). Corticosteroids will be continued throughout the study in the belatacept arm. The primary objective is to evaluate whether NULOJIX® (belatacept), when implemented with gradual tacrolimus withdrawal over 9 months, is safe with respect to preventing the composite endpoint of acute cellular rejection (ACR) \>= International Society of Heart and Lung Transplantation (ISHLT) 2R, hemodynamic compromise rejection in the absence of a biopsy or histological rejection, re-transplantation, and death at 18 months post-transplant.


Eligibility

Min Age: 18 YearsMax Age: 71 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Belatacept, a drug called Mycophenolate Mofetil/Sodium, and others for people with heart transplant. The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBelatacept

Patients will receive 10mg/kg on Day 3 post-transplant (72 hours +/- 12 hours post-transplant) Day 7 post-transplant (+/- 6 hours) Day 16 (End of Week 2 after 1st dose of belatacept) post-transplant (+/- 2 days) Day 30 (End of Week 4 after 1st dose of belatacept) post-transplant (+/- 3 days) Day 58 (Week 8) post-transplant (+/- 3 days) Day 86 (Week 12) post-transplant (+/- 3 days) Patients will receive 5mg/kg Every 28 days (+/- 3 days) thereafter

DRUGTacrolimus

Prograf (tacrolimus) or tacrolimus generic

DRUGMycophenolate Mofetil/Sodium

CellCept (mycophenolate mofetil- MMF), or Myfortic (mycophenolate sodium)

DRUGPrednisone

Prednisone


Locations(5)

Cedars Sinai Heart Institute/ Cedars Sinai Medical (Site # 71146)

Los Angeles, California, United States

Tampa General Hospital (Site # 71150)

Tampa, Florida, United States

St. Luke's Hospital of Kansas City

Kansas City, Missouri, United States

NYU Langone Health (Site # 71177)

New York, New York, United States

University of Utah Medical Center (Site # 71126)

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT06478017


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