Multimodal prospective approach to understand acute and chronic lung transplant rejection
Official title: GRAfT 2.0. A Multimodal Prospective Approach to Define the Mechanisms and Clinical Features of Acute and Chronic Rejection in Lung Transplantation
Run by National Institutes of Health Clinical Center (CC) · NCT07516379 · Data updated 2026-11-12
This project will see if blood tests, airway sampling, imaging, and genetic analyses can identify which adults who have had or are being evaluated for a lung transplant will develop antibody‑mediated rejection and later chronic graft dysfunction.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Status | Recruiting |
| Started | May 11, 2026 |
| Main results expected | March 27, 2032 |
| Study ends | March 27, 2032 |
| Registry record updated | July 22, 2026 |
| Trial ID | NCT07516379 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 who have had or are being evaluated for lung transplantation and who can comply with serial visits and procedures are ideal candidates.
✕Probably not a fit
Patients who are pregnant or breastfeeding, unable to undergo bronchoscopy or frequent follow-up, or unwilling to travel to the NIH Clinical Center are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, observational project recruiting adults who have undergone or are being evaluated for lung transplantation to the NIH Clinical Center. Participants will have clinic visits every 3–6 months for up to four years with blood draws, bronchoscopy with bronchoalveolar lavage, imaging, pulmonary function testing, and genetic/molecular profiling. The study will track donor-specific antibody (DSA) emergence and profile molecular changes that occur from DSA detection through acute antibody‑mediated rejection (AMR) and development of chronic lung allograft dysfunction (CLAD). Data aim to link clinical, imaging, and molecular signatures to timing and mechanisms of rejection.
Why it matters
Potential benefit: If successful, the work could enable earlier, more personalized detection and treatment strategies to prevent antibody‑mediated rejection and slow progression to chronic graft dysfunction.
How similar studies have gone: Previous research has linked donor‑specific antibodies to lung transplant rejection, but comprehensive longitudinal molecular profiling to predict AMR and CLAD is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States Recruiting
Study contacts
- Principal investigator: Muhtadi H Alnababteh, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
- Study coordinator: Andrew G Keel, C.R.N.P.
- Email: andrew.keel@nih.gov
- Phone: (301) 648-5674
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.