Belumosudil for Preventing Lung Transplant Complications
This study is testing if a drug called Belumosudil can help prevent Chronic Lung Allograft Dysfunction (CLAD) in people who have received a lung transplant. CLAD is a serious problem where the transplanted lung doesn't work as well over time. You might be able to join if you are 12 years or older, have had a single or bilateral lung transplant, and a recent biopsy (a small tissue sample) showed signs of rejection or inflammation in your transplanted lung(s). These signs include Acute Rejection (AR), Lymphocytic Bronchiolitis (LB), Organizing Pneumonia (OP), or Acute Lung Injury (ALI). Participants will take Belumosudil or a placebo (an inactive substance) for one year, along with their usual medications. The main goal is to see if Belumosudil can delay or prevent CLAD, the need for another lung transplant, or death. The study is currently recruiting about 234 participants.
- Study design
- This is an interventional study comparing Belumosudil to a placebo. It plans to enroll 234 participants.
- What's involved
- You would take Belumosudil or a placebo daily for one year, along with your regular maintenance medications.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed from the start of the study until its completion, with scheduled assessments for a minimum of 1 year and a maximum of 3 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients
At a glance
Conditions
Where it's being run
12 sites across 10 statesStudy leadership
- Scott M. Palmer, M.D., M.H.S. · STUDY_CHAIR · Duke University Medical Center: Transplantation
Who to contact
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What this trial measures
- Time from randomization to the first occurrence of probable or definite CLAD (per ISHLT 2019 standard defined criteria), lung retransplant, or deathFrom randomization until study completion - scheduled assessments: minimum of 1 year, maximum of 3 years
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