NCT07516379 GRAfT 2.0. A Multimodal Prospective Approach to Define the Mechanisms and Clinical Features of Acute and Chronic Rejection in Lung Transplantation
| NCT ID | NCT07516379 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
| Condition | Lung Transplant |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-05-11 |
| Primary Completion | 2032-03-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-05-11 with a primary completion date of 2032-03-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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. ...
Eligibility Criteria
* 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 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
Contact & Investigator
Muhtadi H Alnababteh, M.D.
PRINCIPAL INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)
Frequently Asked Questions
Who can join the NCT07516379 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Lung Transplant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07516379 currently recruiting?
Yes, NCT07516379 is actively recruiting participants. Contact the research team at andrew.keel@nih.gov for enrollment information.
Where is the NCT07516379 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT07516379 clinical trial?
NCT07516379 is sponsored by National Heart, Lung, and Blood Institute (NHLBI). The principal investigator is Muhtadi H Alnababteh, M.D. at National Heart, Lung, and Blood Institute (NHLBI). The trial plans to enroll 100 participants.