Belatacept in Heart Transplantation
ConditionHeart Transplant
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-71
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
About this trial
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 criteria
Qualifiers
Subject must be able to understand the purpose of the study and be willing to participate and provide written consent
Recipient of a primary heart transplant (heart transplant only)
Epstein-Barr Virus (EBV) seropositive (VCA IgG, EBNA IgG). If EBNA is not available, enrollment may proceed but the result must be available prior to randomization.
Agreement to use contraception; according to the Food and Drug Administration (FDA) Office of Women's Health (http://www.fda.gov/birthcontrol), there are a number of birth control methods that are more than 80% effective. Female participants of child-bearing potential must consult with their physician and determine the most suitable method(s) from this list to be used for the duration of the study
Disqualifiers
Candidate for multiple solid organ or tissue transplants
Prior history of any organ, tissue, or cellular transplant
Currently breast-feeding a child or plans to become pregnant during the timeframe of the study follow up period
History of severe allergic and/or anaphylactic reactions to humanized or murine monoclonal antibodies
Trial design
Treatments tested in this trial
- Belatacept
- Tacrolimus
- Mycophenolate Mofetil/Sodium
- Prednisone
Treatment groups
66 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov