Clinical Research Directory
Browse clinical research sites, groups, and studies.
Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
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 lung(s). 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.
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)
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
234
Start Date
2025-03-12
Completion Date
2027-06-30
Last Updated
2026-01-20
Healthy Volunteers
No
Conditions
Interventions
Belumosudil
Participants will receive Belumosudil 200 mg daily (increased to 200 mg twice daily in participants receiving concurrent strong CYP3A inducers or PPIs) + maintenance IS for a duration of one year from randomization.
Placebo for Belumosudil
Participants will receive Placebo for Belumosudil 200 mg daily (increased to 200 mg twice daily in participants receiving concurrent strong CYP3A inducers or PPIs) + maintenance IS for a duration of one year from randomization.
Locations (10)
University of California, Los Angeles (Site #: 71123)
Los Angeles, California, United States
Johns Hopkins (Site #: 71119)
Baltimore, Maryland, United States
University of Minnesota (Site 71151)
Minneapolis, Minnesota, United States
Washington University (Site #: 71157)
St Louis, Missouri, United States
NYU Langone Health (Site #: 71177)
New York, New York, United States
Duke University (Site #: 71139)
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center (Site #: 71017)
Cincinnati, Ohio, United States
Cleveland Clinic (Site #: 71101)
Cleveland, Ohio, United States
University of Pennsylvania (Site #: 71111)
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center (Site #: 71174)
Nashville, Tennessee, United States