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Clinical trialNCT06478017RecruitingPhase 2Interventional

Belatacept in Heart Transplantation

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment66Heart Transplant
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Cedars Sinai Heart Institute/ Cedars Sinai Medical (site # 71146)

    Los Angeles, California, United States

    Recruiting
  • Tampa General Hospital (site # 71150)

    Tampa, Florida, United States

    Recruiting
  • Emory University Hospital (site #: 71103)

    Atlanta, Georgia, United States

    Recruiting
  • St. Luke'S Hospital of Kansas City

    Kansas City, Missouri, United States

    Recruiting
  • Nyu Langone Health (site # 71177)

    New York, New York, United States

    Recruiting
  • University of Utah Medical Center (site # 71126)

    Salt Lake City, Utah, United States

    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
29 Jan 2025
Primary completion
31 Jan 2028
Completion
31 Jan 2028
Last update posted
22 Jul 2026
Registered enrollment
66
Registry id
NCT06478017

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.