Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06033196
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2023-08-24
Brief Title:
Tocilizumab in Lung Transplantation
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Targeting Inflammation and Alloimmunity in Lung Transplant Recipients With Tocilizumab CTOT-45
Status:
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:
ALL IN LUNG
Brief Summary:
This is a trial in which 350 primary lung transplant recipients will be randomized 11 to receive either Tocilizumab six doses over 20 weeks plus standard triple maintenance immunosuppression or placebo sterile normal saline plus standard triple maintenance immunosuppression Tacrolimus Mycophenolate Mofetil corticosteroids
The primary objective is to test the hypothesis that treatment with triple maintenance immunosuppression plus Tocilizumab TCZ is superior to triple maintenance immunosuppression plus placebo saline as defined by a composite endpoint of a CLAD b listed for re-transplantation and c death
The primary objective is to test the hypothesis that treatment with triple maintenance immunosuppression plus Tocilizumab TCZ is superior to triple maintenance immunosuppression plus placebo saline as defined by a composite endpoint of a CLAD b listed for re-transplantation and c death
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