Study of Belumosudil to Prevent Chronic Lung Allograft Dysfunction in Lung Transplant Patients with High Risk Biopsies

What this Trial Is About

Researchers are studying whether taking Belumosudil along with usual care and medication for 52 weeks can prevent Chronic Lung Allograft Dysfunction CLAD in lung transplant recipients who have a biopsy showing rejection or inflammation in their transplanted lungs. The study focuses on patients with biopsy evidence of Acute Rejection, Lymphocytic Bronchiolitis, Organizing Pneumonia, or Acute Lung Injury, conditions linked to the development of CLAD. Belumosudil is an investigational drug that blocks molecules involved in inflammation and scarring and is already approved for treating chronic graft-versus-host disease in patients 12 years and older. Participants will be randomly assigned to receive either Belumosudil plus maintenance immunosuppression or a placebo plus maintenance immunosuppression for one year. The Belumosudil dose is 200 mg daily but may be increased to 200 mg twice daily for those taking certain other medications. The study compares how well Belumosudil plus standard therapy prevents CLAD, lung retransplant, or death versus placebo plus standard therapy. During the study, participants will be monitored for at least one year and up to three years to track the time until CLAD develops, lung retransplantation, or death. Researchers will also measure lung function tests and the frequency of lung rejection events. Safety labs, viral tests, and vaccination status will be checked before enrollment. Participants will be followed regularly to assess lung health and overall outcomes throughout the study period.

Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients