New drug aims to stop lung transplants from failing
NCT ID NCT06476132
First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times
Summary
This study tests whether the drug belumosudil can prevent chronic lung allograft dysfunction (CLAD) in people who have had a lung transplant and show signs of rejection or inflammation on a biopsy. About 234 participants will receive either belumosudil or a placebo for 52 weeks, in addition to their usual anti-rejection medications. The goal is to see if the drug can delay or prevent CLAD, the need for another transplant, or death.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 234 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
12 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cincinnati Children's Hospital Medical Center (Site #: 71017)
RECRUITINGCincinnati, Ohio, 45229, United States
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Cleveland Clinic (Site #: 71101)
RECRUITINGCleveland, Ohio, 44195, United States
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Duke University (Site #: 71139)
RECRUITINGDurham, North Carolina, 27710, United States
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Johns Hopkins (Site #: 71119)
RECRUITINGBaltimore, Maryland, 21287, United States
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NYU Langone Health (Site #: 71177)
RECRUITINGNew York, New York, 10016, United States
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Stanford University (Site #: 71141)
RECRUITINGPalo Alto, California, 94304, United States
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University Health Network/Toronto General Hospital (Site #: 71121)
RECRUITINGToronto, Ontario, Canada
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University of California, Los Angeles (Site #: 71123)
RECRUITINGLos Angeles, California, 90095, United States
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University of Minnesota (Site 71151)
RECRUITINGMinneapolis, Minnesota, 55455, United States
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University of Pennsylvania (Site #: 71111)
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Vanderbilt University Medical Center (Site #: 71174)
RECRUITINGNashville, Tennessee, 37232, United States
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Washington University (Site #: 71157)
RECRUITINGSt Louis, Missouri, 63130, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could a simple neck band protect transplanted lungs from stomach acid?
- Lung transplant showdown: which surgical method wins?
- New registry aims to boost lung transplants by reconditioning donor lungs
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