Clinical trial Recruiting at 12 sites Phase 2 Interventional Ages 12 and up

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

PhasePhase 2
Study typeInterventional
Ages12 Years and up
SexAll
Enrollment234 (estimated)
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
NIH
Drugs / interventionsalemtuzumab
Locations12 sites (Los Angeles, California and 11 other locations)
StatusRecruiting
StartedMarch 12, 2025
Main results expectedMay 30, 2027
Study endsJune 30, 2027
Registry record updatedAugust 10, 2026
Trial IDNCT06476132 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Research on improving outcomes for lung transplant donors and recipients

    This study is trying to see how different donor and medical practices affect the health of lung transplant patients and donors, while also looking for blood markers that might predict complications after the surgery.

    Recruiting at 19 sites Duke University · Los Angeles, California and 18 other locations · NCT06399302

  • Multidisciplinary non-drug program to improve quality of life after solid organ transplant

    A multidisciplinary, non-drug program using acupuncture, remote physical rehab, and brain-health activities is being tested to see if it can improve quality of life for adults at least one year after heart, kidney, liver, or lung transplant.

    Recruiting The Mediterranean Institute for Transplantation and Advanced Specialized Therapies · Palermo, Palermo · NCT07870811

  • Multimodal prospective approach to understand acute and chronic lung transplant rejection

    This project will see if blood tests, airway sampling, imaging, and genetic analyses can identify which adults who have had or are being evaluated for a lung transplant will develop antibody‑mediated rejection and later chronic graft dysfunction.

    Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07516379

  • Airway response to exercise after double lung transplant

    This study will see if short (5-minute) versus longer (15-minute) constant-work exercise causes different airway narrowing and breathlessness in people who have had a double lung transplant.

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  • Cryo nerve block to improve recovery after bilateral lung transplant

    This pilot will test whether adding a cryo nerve block around the chest helps people with end-stage COPD recover better after a bilateral lung transplant.

    Recruiting University Hospital, Gasthuisberg · Leuven, Vlaams-Brabant · NCT06959056

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.