TRAnscriptional Profile of Peripheral Blood Cells in Patient With Chronic Kidney and Lung Rejecti… (NCT07316829) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
TRAnscriptional Profile of Peripheral Blood Cells in Patient With Chronic Kidney and Lung Rejection: Correlation With Response to Extracorporeal Photo-aphereSiS
Italy30 participantsStarted 2025-04-10
Plain-language summary
With this project, the research team aims to identify the molecular pathways associated with the response to extracorporeal photonchemioapheresis (ECP) in kidney or lung transplant patients suffering from chronic rejection, by analyzing gene expression in samples of peripheral blood mononuclear cells.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* Kidney transplant recipients with biopsy-proven AMCR
* Lung transplant recipients with CLAD, defined as a persistent decline in FEV1 ≥ 20% compared with post-transplant baseline in the absence of other causes
* Patients receiving standard immunosuppressive therapy and eligible for Extracorporeal Photoapheresis (ECP)
* Ability to provide informed consent
Exclusion Criteria:
* Active infection or uncontrolled comorbidities that contraindicate ECP
* Pregnancy or breastfeeding
* Participation in another interventional trial that could interfere with outcomes
* Inability to comply with study procedures
Additional Notes:
* Both prevalent and incident cases may be included (ambispective design).
* Patients will be followed longitudinally for clinical outcomes, donor-specific antibodies, and gene expression profiling at baseline, 6 months, and 12 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
omparison of gene expression profiles between responders and non-responders to Extracorporeal Photoapheresis (ECP)