Ignite Creation Date:
2024-07-17 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476132
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-05-08
Brief Title:
Belumosudil to Block Chronic Lung Allograft Dysfunction CLAD in High Risk Lung Transplant Recipients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Belumosudil to Block Chronic Lung Allograft Dysfunction CLAD in High Risk Lung Transplant Recipients A Randomized Multicenter Double Blind Placebo-Controlled Trial CTOT-47
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:
CLAD
Brief Summary:
The purpose of this study is to see if taking the study drug Belumosudil for 52 weeks in addition to your usual care and medication will prevent Chronic Lung Allograft Dysfunction CLAD in participants who have a lung biopsy that shows evidence of rejection or inflammation to the transplanted lungs For this study biopsies that show evidence of Acute Rejection AR Lymphocytic Bronchiolitis LB Organizing Pneumonia OP or Acute Lung Injury ALI are referred to as Qualifying Biopsies patients who had evidence of one or more of these conditions on a recent biopsy are eligible for enrollment in this study Belumosudil is an investigational drug that blocks a molecule in the body that reduces inflammation and scarring and may play a role in the development and progression of CLAD Belumosudil is a drug approved by the FDA to treat adults and children 12 years and older with chronic graft-versus-host disease cGVHD a condition with some similarities to CLAD
The primary objective it to determine the efficacy of treatment with Belumosudil maintenance immunosuppression IS versus placebo maintenance IS on preventing the subsequent development of probable or definite CLAD lung retransplant or death
The primary objective it to determine the efficacy of treatment with Belumosudil maintenance immunosuppression IS versus placebo maintenance IS on preventing the subsequent development of probable or definite CLAD lung retransplant or 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