Actively Recruiting
Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients: A Randomized, Multicenter, Double Blind, Placebo-Controlled Trial (CTOT-47)
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-12
234
Participants Needed
12
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding the drug Belumosudil to usual care for 52 weeks can help prevent Chronic Lung Allograft Dysfunction (CLAD) in lung transplant recipients who have biopsy evidence of rejection or inflammation. This study focuses on participants aged 12 and older with recent lung biopsies showing Acute Rejection (AR), Lymphocytic Bronchiolitis (LB), Organizing Pneumonia (OP), or Acute Lung Injury (ALI). Belumosudil is an investigational drug that targets inflammation and scarring that may contribute to CLAD development. Participants who had a qualifying biopsy between 60 and 550 days after lung transplant will be randomly assigned to one of two groups. One group receives Belumosudil 200 mg daily (adjusted to twice daily if taking certain other medications) plus maintenance immunosuppression for one year. The other group receives a placebo plus maintenance immunosuppression for the same period. This is a double-blind study, so neither participants nor researchers know which treatment is given. During the study, participants will be regularly assessed for the time until the first occurrence of probable or definite CLAD, lung retransplant, or death for a minimum of one year and up to three years. Researchers will also monitor lung function, acute rejection events, and specific lung injury types. Safety labs, virus tests, and evaluations of overall health will be conducted. The study aims to understand if Belumosudil can help improve long-term outcomes after lung transplant.
CONDITIONS
Brief Title
Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or guardian must understand the study purpose, agree to participate, and provide consent or assent
- Single or bilateral lung transplant recipient aged 12 years or older
- Qualifying biopsy 60 to 550 days post-transplant showing acute rejection, lymphocytic bronchiolitis, organizing pneumonia, or acute lung injury
- Females of reproductive potential and males with partners of reproductive potential must agree to use effective contraception during treatment and for 3 months after
- Meet blood count criteria: neutrophils >= 0.5 x 10^9/L and platelets >= 50 x 10^9/L within 30 days before enrollment
- Meet blood chemistry criteria: liver enzymes less than 2 times upper limit, bilirubin less than 1.5 times upper limit unless Gilbert's syndrome, and kidney function eGFR >= 30 mL/min/1.73m2 within 30 days before enrollment
- Negative cytomegalovirus PCR test within 30 days before enrollment
- Received adult vaccinations or documented immunity per guidelines if no contraindications
- Receiving calcineurin inhibitor-based maintenance immunosuppression
You will not qualify if you...
- Multi-organ transplants involving more than one organ type
- Prior organ or bone marrow transplant
- More than 120 days after the qualifying biopsy
- Clinical antibody-mediated rejection before enrollment (subclinical allowed if at least 90 days prior)
- Diagnosed with probable or definite chronic lung allograft dysfunction before enrollment
- Recent treatment with anti-thymocyte globulin, alemtuzumab, or prohibited medications within specified timeframes
- Epstein-Barr virus negative recipients with EBV positive donor lungs
- Treatment with other investigational drugs within 30 days before enrollment
- Significant uncontrolled infections
- Current use of sirolimus or everolimus
- Positive for HIV
- Positive for hepatitis B or C infection unless cleared with documented tests
- History of major surgical or mechanical lung problems affecting function
- Other medical or psychosocial issues that increase risk or interfere with study
- Pregnant or breastfeeding
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 year from randomization
Participants receive daily Belumosudil or placebo plus maintenance immunosuppression for one year from randomization.
Regular visits during treatment for assessments and medication management
Duration - Minimum of 1 year, maximum of 3 years from randomization
Participants are assessed for a minimum of 1 year and up to 3 years after randomization to monitor outcomes such as lung function, chronic lung allograft dysfunction, retransplant, or death.
At least annual visits for up to 3 years
Trial Site Locations
Total: 12 locations
1
University of California, Los Angeles (Site #: 71123)
Los Angeles, California, United States, 90095
Actively Recruiting
2
Stanford University (Site #: 71141)
Palo Alto, California, United States, 94304
Actively Recruiting
3
Johns Hopkins (Site #: 71119)
Baltimore, Maryland, United States, 21287
Actively Recruiting
4
University of Minnesota (Site 71151)
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
5
Washington University (Site #: 71157)
St Louis, Missouri, United States, 63130
Actively Recruiting
6
NYU Langone Health (Site #: 71177)
New York, New York, United States, 10016
Actively Recruiting
7
Duke University (Site #: 71139)
Durham, North Carolina, United States, 27710
Actively Recruiting
8
Cincinnati Children's Hospital Medical Center (Site #: 71017)
Cincinnati, Ohio, United States, 45229
Actively Recruiting
9
Cleveland Clinic (Site #: 71101)
Cleveland, Ohio, United States, 44195
Actively Recruiting
10
University of Pennsylvania (Site #: 71111)
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
11
Vanderbilt University Medical Center (Site #: 71174)
Nashville, Tennessee, United States, 37232
Actively Recruiting
12
University Health Network/Toronto General Hospital (Site #: 71121)
Toronto, Ontario, Canada
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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