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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

NCT07516379 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-05-14

No results posted yet for this study

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 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

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    collaborator NIH

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Muhtadi H Alnababteh, M.D. · National Heart, Lung, and Blood Institute (NHLBI)

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-11
Primary Completion
2032-03-27
Completion
2032-03-27

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07516379 on ClinicalTrials.gov