Recruiting

Lung Transplant Rejection

Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Code:

NCT07516379

Conditions

Lung Transplant

End Stage Lung Disease

Rejection

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

...

Conditions

Lung Transplant

End Stage Lung Disease

Rejection

Study ID

NCT07516379

Start date

May 11, 2026

Status verified date

Jul 20, 2026

Completion date

Mar 27, 2032

Anticipated

Primary completion date

Mar 27, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • 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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

DSA-

Lung transplant patients who didn't develop donor specific antibodies

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 and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

NIH Clinical Center Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Last update posted

Jul 22, 2026

Last verified

Jul 20, 2026

Keywords

  • Lung Transplant
  • Rejection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI) on 2026-07-22.