Ignite Creation Date:
2024-07-17 @ 11:01 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478017
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-07
Brief Title:
Belatacept in Heart Transplantation
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Belatacept With Delayed Tacrolimus Withdrawal Versus Standard-of-Care Tacrolimus in Heart Transplant Recipients RTB-013
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase 2 prospective multi-center open-label clinical trial Sixty-six 66 primary heart transplant recipients will be randomized 12 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None