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NCT06476132 · ClinicalTrials.gov registry record · Phase 2
Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients
A Phase 2 study of Lung Transplant, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 234
- Enrollment target
- 10
- Study locations
NCT06476132: Recruiting Phase 2 study of Lung Transplant, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT06476132 is a Phase 2 study of Lung Transplant that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 234 participants, below the 1,261-participant average among 15 other Lung Transplant trials with a reported enrollment target (81% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06476132, a Phase 2 study of Lung Transplant, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 234 participants
- Enrollment target
- 10
- Study locations
Study Summary
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.
Primary Outcome
Probable CLAD is defined as a \>= 20% decline in Forced Expiratory Volume in 1 Second (FEV1) compared to the baseline value on 2 measurements taken at least 3 weeks apart and after exclusion or adequate treatment of potential secondary causes of allograft dysfunction. The baseline FEV1 value is defined as the average of the 2 best posttransplant FEV1s taken at least 3 weeks apart
Conditions Studied
Interventions
- DRUG Belumosudil
- DRUG Placebo for Belumosudil
Study Locations (10)
Ohio
- Cincinnati Children's Hospital Medical Center (Site #: 71017) - Cincinnati
- Cleveland Clinic (Site #: 71101) - Cleveland
California
- University of California, Los Angeles (Site #: 71123) - Los Angeles
Maryland
- Johns Hopkins (Site #: 71119) - Baltimore
Minnesota
- University of Minnesota (Site 71151) - Minneapolis
Missouri
- Washington University (Site #: 71157) - St Louis
New York
- NYU Langone Health (Site #: 71177) - New York
North Carolina
- Duke University (Site #: 71139) - Durham
Pennsylvania
- University of Pennsylvania (Site #: 71111) - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 234 participants |
| Start Date | 2025-03-12 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 2 |
What NCT06476132 shows while recruiting
NCT06476132 is an interventional study that assigns participants to a tested intervention. The registered 234 participants enrollment target is mid-sized for trials with a published cap, below the 1,261-participant average among 15 other Lung Transplant trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Lung Transplant appearing as the primary indexed condition, and to 2 interventions - of which Belumosudil is the first listed.
NCT06476132 lists 10 locations in 9 states (Ohio, California, Maryland).
Frequently Asked Questions
What is clinical trial NCT06476132 about?
NCT06476132 is a clinical study titled "Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients". 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 lu...
What is the current status of trial NCT06476132?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 234 participants. The study started on 2025-03-12. Estimated completion is 2027-06-30.
What conditions does trial NCT06476132 study?
This clinical trial studies the following conditions: Lung Transplant.
What interventions are being tested in trial NCT06476132?
The interventions under investigation include: Belumosudil (DRUG), Placebo for Belumosudil (DRUG).
Who is sponsoring clinical trial NCT06476132?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06476132 being conducted?
This trial has 10 study locations across California, Maryland, Minnesota, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06476132's enrollment target sits among peer trials
234 6th of 15 higher than 10 of 15 other Lung Transplant trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lung Transplant trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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