Protocol Details
GRAfT 2.0. A Multimodal Prospective Approach to Define the Mechanisms and Clinical Features of Acute and Chronic Rejection in Lung Transplantation
This study is currently recruiting participants.
Summary
Number |
002352-H |
Sponsoring Institute |
National Heart, Lung and Blood Institute (NHLBI) |
Recruitment Detail |
Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 75 Years |
Referral Letter Required |
No |
Population Exclusion(s) |
Pregnant Women;
Children |
Keywords |
Lung Transplant;
Rejection |
Recruitment Keyword(s) |
None |
Condition(s) |
Lung Transplant;
End stage Lung disease;
Rejection |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
NIH Clinical CenterNational Heart, Lung, and Blood Institute |
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
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
Citations:
Alnababteh M, Sun J, Meda R, Ponor L, Shah P, Mathew J, Kong H, Charya A, Helen Luikart RN, Aryal S, Nathan SD, Orens JB, Khush KK, Jang M, Agbor-Enoh S, Keller MB. Impact of donor specific antibodies on longitudinal lung function and baseline lung allograft dysfunction. J Heart Lung Transplant. 2025 Nov;44(11):1766-1773. doi: 10.1016/j.healun.2025.06.012. Epub 2025 Jun 26. PMID: 40581272.
Alnababteh M, Keller MB, Kong H, Phipps K, Namian J, Ponor L, Shah P, Mathews J, Andargie T, Park W, Orens JB, Aryal S, Nathan SD, Bush E, Redekar N, Hill T, Jang M, Tian X, Agbor-Enoh S. Early Post-Transplant Recipient Tissue Injury Predicts Allograft Function, Rejection, and Survival in Lung Transplant Recipients, Evidence from Cell-free DNA. Eur Respir J. 2025 Jul 31:2402537. doi: 10.1183/13993003.02537-2024. Epub ahead of print. PMID: 40744691.
Keller MB, Newman D, Alnababteh M, Bon A, Ponor L, Shah P, Mathew J, Kong H, Andargie T, Park W, Charya A, Luikart H, Intrieri T, Aryal S, Nathan SD, Orens JB, Khush KK, Jang M, Agbor-Enoh S. Molecular criteria for pulmonary antibody-mediated rejection are associated with an increased risk of allograft failure. J Heart Lung Transplant. 2025 Oct;44(10):1535-1542. doi: 10.1016/j.healun.2025.03.015. Epub 2025 Mar 20. PMID: 40120999; PMCID: PMC12353349.
Agbor-Enoh S, Jackson AM, Tunc I, Berry GJ, Cochrane A, Grimm D, Davis A, Shah P, Brown AW, Wang Y, Timofte I, Shah P, Gorham S, Wylie J, Goodwin N, Jang MK, Marishta A, Bhatti K, Fideli U, Yang Y, Luikart H, Cao Z, Pirooznia M, Zhu J, Marboe C, Iacono A, Nathan SD, Orens J, Valantine HA, Khush K. Late manifestation of alloantibody-associated injury and clinical pulmonary antibody-mediated rejection: Evidence from cell-free DNA analysis. J Heart Lung Transplant. 2018 Jul;37(7):925-932. doi: 10.1016/j.healun.2018.01.1305. Epub 2018 Jan 31. PMID: 29500138.
Contacts:
Clinical Trials Number:
NCT07516379