Using Belumosudil to prevent lung transplant complications
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)
Run by National Institute of Allergy and Infectious Diseases (NIAID) · NCT06476132 · Data updated 2026-11-12
This study is testing if a new drug called Belumosudil can help prevent lung transplant complications in high-risk patients who have signs of rejection or inflammation.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 12 Years and up |
| Sex | All |
| Enrollment | 234 (estimated) |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) NIH |
| Drugs / interventions | alemtuzumab |
| Locations | 12 sites (Los Angeles, California and 11 other locations) |
| Status | Recruiting |
| Started | March 12, 2025 |
| Main results expected | May 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | August 10, 2026 |
| Trial ID | NCT06476132 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are lung transplant recipients aged 12 and older who have evidence of acute rejection or inflammation in their recent lung biopsy.
✕Probably not a fit
Patients without recent qualifying biopsies showing acute rejection or inflammation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of Belumosudil, an investigational drug, in preventing Chronic Lung Allograft Dysfunction (CLAD) in high-risk lung transplant recipients. Participants who have had a lung biopsy showing signs of rejection or inflammation will receive Belumosudil for 52 weeks alongside their usual care. The study aims to determine if this drug can reduce inflammation and scarring in the transplanted lungs, potentially improving patient outcomes. Eligible participants must be lung transplant recipients aged 12 years or older with specific biopsy results indicating allograft injury.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of CLAD in lung transplant recipients, improving their long-term health and transplant success.
How similar studies have gone: While Belumosudil is already approved for treating chronic graft-versus-host disease, its application in preventing CLAD is novel and has not been extensively tested in similar studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participant and/or parent or guardian must be able to understand the purpose of the study, willing to participate, sign the informed consent, and if applicable assent. 2. Single or bilateral lung transplant recipient age ≥ 12 years 3. A qualifying biopsy obtained 60 to 760 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 or, if detected, \<200 IU/ml in the absence of any signs of active infection, 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. Intent to receive calcineurin inhibitor (CNI)-based maintenance Immunosuppression (IS) regimen Exclusion Criteria: 1. Multi-organ transplants involving more than one organ type (e.g., heart-lung) 2. Prior organ transplant or prior bone marrow transplant/hematopoietic stem cell transplantation 3. Greater than 160 days after a qualifying biopsy 4. Active AMR unless resolved and no treatments with prohibited medications for \> 90 days 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. Incompletely treated Hepatitis C (absence of ongoing treatment and post-transplant negative HCV PCR) 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
Where it's running
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University of California, Los Angeles (Site #: 71123)
Los Angeles, California, United States Recruiting -
Stanford University (Site #: 71141)
Palo Alto, California, United States Recruiting -
Johns Hopkins (Site #: 71119)
Baltimore, Maryland, United States Recruiting -
University of Minnesota (Site 71151)
Minneapolis, Minnesota, United States Recruiting -
Washington University (Site #: 71157)
St Louis, Missouri, United States Recruiting -
NYU Langone Health (Site #: 71177)
New York, New York, United States Recruiting
Show 6 more locations
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Duke University (Site #: 71139)
Durham, North Carolina, United States Recruiting -
Cincinnati Children's Hospital Medical Center (Site #: 71017)
Cincinnati, Ohio, United States Recruiting -
Cleveland Clinic (Site #: 71101)
Cleveland, Ohio, United States Recruiting -
University of Pennsylvania (Site #: 71111)
Philadelphia, Pennsylvania, United States Recruiting -
Vanderbilt University Medical Center (Site #: 71174)
Nashville, Tennessee, United States Recruiting -
University Health Network/Toronto General Hospital (Site #: 71121)
Toronto, Ontario, Canada Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.