Actively Recruiting
Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-12
234
Participants Needed
12
Research Sites
120 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 understands the study and agrees to participate with signed consent
- Single or bilateral lung transplant recipient aged 12 years or older
- Recent qualifying lung biopsy obtained 60 to 550 days after transplant showing Acute Rejection, Lymphocytic Bronchiolitis, Organizing Pneumonia, or Acute Lung Injury
- Agreement to use effective contraception during treatment and for 3 months after
- Hematologic labs within 30 days: ANC >= 0.5 x 10^9/L and platelets >= 50 x 10^9/L
- Blood chemistry labs within 30 days: AST or ALT less than 2 times upper limit, bilirubin less than 1.5 times upper limit unless Gilbert's syndrome, eGFR >= 30 mL/min/1.73m2
- Negative Cytomegalovirus PCR within 30 days
- Received adult vaccinations or has documented immunity per NIAID guidance
- Receiving Calcineurin Inhibitor-based maintenance immunosuppression
You will not qualify if you...
- Multi-organ transplant involving more than one organ type
- Prior organ transplant or bone marrow/hematopoietic stem cell transplant
- More than 120 days since qualifying biopsy
- Clinical antibody-mediated rejection before enrollment
- Diagnosed with probable or definite CLAD before enrollment
- Recent treatment with anti-thymocyte globulin, alemtuzumab, or prohibited medications
- Epstein-Barr virus seronegative recipient from EBV positive donor
- Use of other investigational drugs within 30 days
- Significant uncontrolled infection
- Current use of sirolimus or everolimus
- HIV positive recipient
- Hepatitis B surface antigen or core antibody positive recipient
- Received lungs from donor with known Hepatitis B
- History of Hepatitis C or received lungs from donor with Hepatitis C unless cleared
- Significant surgical or mechanical lung issues affecting function
- Other medical or psychosocial conditions posing risk or interfering with study
- Pregnant or breastfeeding
AI-Screening
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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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