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

Who can join

Ages 18 to 75 · All sexes

* INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Stated willingness to comply with study procedures and availability for the duration of the study.
2. Male or female, aged 18 - 75 years of age.
3. Have progressive lung disease or undergone or being evaluated for lung transplantation.
4. Ability of subjects to understand the informed consent document.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1\. Pregnancy or lactation

About the study

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.

...

Sponsor: National Heart, Lung, and Blood Institute (NHLBI) · Participants: 100 · Started: May 11, 2026

Contact the study team

• Andrew G Keel, C.R.N.P. · Phone: (301) 648-5674
• Muhtadi H Alnababteh, M.D. · Phone: (301) 827-3272

Official record on ClinicalTrials.gov — NCT07516379

Locations in the U.S.

Conditions

• Psychology Rejection

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.