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

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 120 days after a qualifying biopsy
• •4. Clinical AMR prior to enrollment. Subclinical AMR is permitted if 90 days or greater 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. Recipient history of Hepatitis C, Hepatitis C seropositive, or received lung(s) from a donor with known Hepatitis C (participants who have 3 months of documented consecutive undetected Hepatitis C virus PCR after treatment or spontaneous clearance will not be excluded).
• •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