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Belatacept in Heart Transplantation

NCT06478017 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-04-07

No results posted yet for this study

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.

Conditions

  • Heart Transplant

Interventions

DRUG

Belatacept

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

DRUG

Tacrolimus

Prograf (tacrolimus) or tacrolimus generic

DRUG

Mycophenolate Mofetil/Sodium

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

DRUG

Prednisone

Prednisone

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Joren C Madsen, MD, DPhil · Massachusetts General Hospital

  • Jon A. Kobashigawa, MD · Cedars-Sinai Medical Center

  • Marlena Habal, MD · NYU Langone Health

  • Christian P. Larsen, MD, DPhil · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
71 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-29
Primary Completion
2028-01-31
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06478017 on ClinicalTrials.gov