GRAfT 2.0 A Multimodal Prospective Approach to Define the Mechanisms and Clinical Features of Acute and Chronic Rejection in Lung Transplantation

What this Trial Is About

Researchers are investigating why some people develop rejection after lung transplants while others do not. The study focuses on lung transplant recipients who develop donor-specific antibodies (DSA) and how these antibodies relate to acute and chronic rejection. The goal is to identify molecular and clinical differences among patients who develop antibody-mediated rejection (AMR) and those who do not, as well as those who develop chronic lung allograft dysfunction (CLAD). Participants include people aged 18 to 75 years with progressive lung disease or those who have undergone or are being evaluated for lung transplantation. They will have clinic visits every 3 to 6 months for up to 4 years. During visits, participants will undergo blood and urine tests, lung imaging including CT and MRI scans, lung function tests, and a six-minute walk test. Optional procedures include bronchoscopy with lavage and endomicroscopy to capture detailed lung images. Throughout the study, researchers will collect data on molecular profiles, lung function, and imaging findings to understand progression from DSA detection to rejection and lung dysfunction. Follow-up visits will include blood draws and various tests to monitor changes. Participants may have overnight stays during some visits. The primary outcome is to compare molecular differences among participants with different rejection statuses over 3 years, along with secondary assessments of lung function and imaging changes.

GRAfT 2.0. A Multimodal Prospective Approach to Define the Mechanisms and Clinical Features of Acute and Chronic Rejection in Lung Transplantation