TRAnscriptional Profile of Peripheral Blood Cells in Patient With Chronic Kidney and Lung Rejection: Correlation With Response to Extracorporeal Photo-aphereSiS
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
omparison of gene expression profiles between responders and non-responders to Extracorporeal Photoapheresis (ECP) — 6 months (lung transplant cohort) and 12 months (kidney transplant cohort) The primary outcome is the difference in gene expression profiles between patients who respond and those who do not respond to ECP treatment. Response is defined based on stabilization or improvement of graft function (eGFR in kidney recipients, FEV1 in lung recipients) and reduction or elimination of donor-specific antibodies. Gene expression profiling will be performed on peripheral blood samples collected at baseline (T0) and after 6 months (lung) or 12 months (kidney) of treatment.
Trial sites (1)
Facility
City
Region
Status
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia
Pavia
More Fondazione IRCCS Policlinico San Matteo di Pavia trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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