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NCT07516379
GRAfT 2.0. A Multimodal Prospective Approach to Define the Mechanisms and Clinical Features of Acute and Chronic Rejection in Lung Transplantation
Conditions: Lung Transplant, End Stage Lung Disease, Rejection
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Enrollment: 100
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Location: National Institutes of Health Clinical Center Bethesda Maryland
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.
...
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 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
Source: ClinicalTrials.gov (NCT07516379). StuddyBuddy aggregates publicly available trial information.
