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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Study ID
NCT07516379
Status
Recruiting
Apply to this trial

Conditions

  • End Stage Lung Disease
  • Lung Transplant
  • Rejection

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Study Details

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. ...

Key Dates

Start date
May 11, 2026
Status verified
Jun 2026
Primary completion
Mar 27, 2032
Completion
Mar 27, 2032

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: DSA-
    Lung transplant patients who didn't develop donor specific antibodies
  • Arm: DSA+
    Lung transplant patients who developed donor specific antibodies

Primary Outcome Measure

Multi-omic molecular differences between DSA+ participants who progress to AMR (DSA+/AMR+), and DSA+ participants who do not progress to AMR (DSA+/AMR-), and DSA- participants [ Time Frame: 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

Find similar trials in Bethesda, MD

By research site
National Institutes of Health Clinical Center· Bethesda, MD

Related Studies