Study to Understand Why Some Lung Transplant Patients Develop Rejection While Others Do Not by Tracking Molecular and Clinical Changes

What this Trial Is About

Researchers are studying lung transplant recipients to understand why some develop donor-specific antibodies DSA and acute or chronic rejection, while others do not. The study investigates molecular differences in those who develop antibody-mediated rejection AMR compared to those who do not, aiming to identify clinical and molecular pathways linked to rejection. This observational study involves people aged 18 to 75 with progressive lung disease or those evaluated for or having received a lung transplant. Participants will have clinic visits every 3 to 6 months for up to 4 years, including some overnight stays. Each visit involves physical exams, blood and urine tests including genetic testing, lung imaging scans with and without contrast agents, a six-minute walk test, and lung function tests. Optional procedures include bronchoscopy with washings and endomicroscopy to obtain detailed lung images. Participants will continue routine care with their transplant programs alongside NIH follow-ups. Throughout the study, researchers will monitor molecular changes from DSA detection to development of acute and chronic rejection, along with lung function and imaging changes. Assessments include physical exams, laboratory tests, imaging scans, and functional tests. The primary outcome focuses on molecular differences over 3 years among groups with and without AMR and DSA. Safety is monitored, and participation may last up to 4 years, with regular follow-up visits to track health and study outcomes.

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