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

Background: Lung transplants can save lives, but the procedure has risks. Some people develop donor-specific antibodies (DSA) after the procedure-that is, their bodies create proteins that treat the new lungs as foreign and mount an immune response against them. This is called rejection. But not everyone who has a transplant develops DSA, and not everyone who has DSA develops rejection. Researchers want to understand why. Objective: To collect data to try to find out why some people develop rejection after lung transplants while others do not. Eligibility: People aged 18 to 75 years who have progressive lung disease or undergone or may undergo a lung transplant. Design: Participants will have clinic visits every 3 to 6 months for up to 4 years. Some visits might require an overnight stay. Each visit will include multiple tests and procedures: Physical exam with blood and urine tests. Some blood will be used for genetic testing. Imaging scans. Participants will have 2 types of scan to get images of their lungs. For one, they will have a contrast agent given through a tube inserted into a vein. Six-minute walk test. Participants will walk back and forth in a hallway at their own pace. Researchers will check on how their body responds. Lung function test. Participants will breathe into a tube connected to a machine. Two other tests are optional: Bronchoscopy with washings (lavage). A long tube with a light will be threaded down through the participant s nose or mouth and into their lungs. Endomicroscopy. During the bronchoscopy a tiny camera may be used to take pictures inside the lungs. ...

NCT Number	NCT07516379
Lead Sponsor	National Heart, Lung, and Blood Institute (NHLBI) Collaborators: National Institutes of Health Clinical Center (CC)
Conditions	Lung Transplant, End Stage Lung Disease, Rejection
Enrollment	100 participants
Start Date	2026-05-11
Primary Completion	2032-03-27 (estimated)
Study Completion	2032-03-27 (estimated)
Updated on ClinicalTrials.gov	2026-07-22