Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients
NCT ID: NCT06476132
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
234 participants
INTERVENTIONAL
2025-03-12
2027-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Belumosudil plus maintenance IS
Eligible lung transplant recipients who experience a qualifying biopsy 60 to 550 days posttransplant will be randomized into the study. 200 mg of Belumosudil (increased to 200 mg twice daily in participants receiving concurrent strong CYP3A inducers or PPIs) + maintenance IS will be administered daily for one year from randomization.
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 + maintenance IS
Eligible lung transplant recipients who experience a qualifying biopsy 60 to 550 days posttransplant will be randomized into the study. Placebo plus maintenance immunosuppression (IS) will be administered for one year
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Single or bilateral lung transplant recipient age ≥ 12 years
3. A qualifying biopsy obtained 60 to 550 days after lung transplant with evidence of allograft injury histology; a qualifying biopsy must have one or more of the following features alone or in combination: Acute Rejection (AR), Lymphocytic Bronchiolitis (LB), Organizing Pneumonia (OP), or Acute Lung Injury (ALI). The presence of any grade AR (A1 or greater) or LB (B1 or greater) qualifies for inclusion
4. Females of reproductive potential and males with female partners of reproductive potential must agree to use effective contraception during treatment with belumosudil or placebo and for at least 3 months after the last dose. Participants must agree to refrain from donating or cryopreserving sperm, eggs (ova or ovocytes) for the purpose of reproduction during treatment with belumosudil or placebo and for at least 3 months after the last dose.
5. Meeting hematologic laboratory criteria: absolute neutrophil count (ANC) \>= 0.5 x 10(9)/L and platelet count \>= 50 x 10(9)/L within 30 days of enrollment
6. Meeting all blood chemistry laboratory criteria: aspartate aminotransferase (AST) or alanine transaminase (ALT) \< 2x upper limit of normal (ULN), bilirubin \< 1.5x ULN unless due to Gilbert's syndrome, estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m2 within 30 days of enrollment
7. Cytomegalovirus (CMV) polymerase chain reaction (PCR) negative within 30 days of enrollment
8. In the absence of contraindications, must have received adult vaccinations or documented immunity as outlined in current National Institute of Allergy and Infectious Diseases (NIAID) Division of Allergy, Immunology, and Transplantation (DAIT) Guidance for Patients in Transplant Trials
9. Receiving Calcineurin Inhibitor (CNI)-based maintenance Immunosuppression (IS) regimen
Exclusion Criteria
2. Prior organ transplant or prior bone marrow transplant/hematopoietic stem cell transplantation
3. Greater than 120 days after a qualifying biopsy
4. Clinical AMR prior to enrollment. Subclinical AMR is permitted if 90 days or greater prior to enrollment.
5. Diagnosed with probable or definite CLAD according to International Society for Heart and Lung Transplantation (ISHLT) guidelines prior to enrollment.
6. Posttransplant treatment with anti-thymocyte globulin within 30 days or alemtuzumab or any other prohibited medication within 90 days prior to enrollment.
7. Epstein-Barr virus (EBV) seronegative recipient who received EBV positive donor lung(s).
8. Treatment with any other investigational pharmacologic agent within 30 days prior to enrollment.
9. Significant active uncontrolled infection which, in the opinion of the investigator, would place the participant at increased risk.
10. Current use of sirolimus or everolimus.
11. Recipient human immunodeficiency virus (HIV) positive.
12. Recipient Hepatitis B surface antigen positive or Hepatitis B core antibody positive.
13. Received lung(s) from a donor with known Hepatitis B virus (HBV) including Hepatitis B core antibody positive donors.
14. Recipient history of Hepatitis C, Hepatitis C seropositive, or received lung(s) from a donor with known Hepatitis C (participants who have 3 months of documented consecutive undetected Hepatitis C virus PCR after treatment or spontaneous clearance will not be excluded).
15. History of clinically significant surgical factors (such as phrenic nerve damage, transplant lung resection, chest wall surgery), or mechanical factors (such as posttransplant airways disease including bronchial dehiscence, stenosis, dilation, or stent placement, pleural disease) that impedes lung function.
16. Past or current medical problems, psychosocial concerns, or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose undue risk from participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.
17. Pregnant or breastfeeding
12 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Scott M. Palmer, M.D., M.H.S.
Role: STUDY_CHAIR
Duke University Medical Center: Transplantation
Locations
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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
Countries
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Facility Contacts
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Related Links
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Division of Allergy, Immunology, and Transplantation (DAIT)
National Institute of Allergy and Infectious Diseases (NIAID)
Other Identifiers
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DAIT CTOT-47
Identifier Type: -
Identifier Source: org_study_id
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