TRAnscriptional Profile of Peripheral Blood Cells in Patient With Chronic Kidney and Lung Rejection: Correlation With Response to Extracorporeal Photo-aphereSiS

NCT07316829 | Active Not Recruiting

• 1 other identifier: TRACKLESS
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Graft Rejection; Kidney Transplantation; Lung Transplantation; Antibody-Mediated Rejection; Chronic Disease; Bronchiolitis Obliterans; HLA Antibodies; Antibodies, Donor-Specific; Immune Tolerance

Keywords

Extracorporeal photoapheresis; Antibody-mediated chronic rejection; Donor-specific antibodies; Kidney transplantation; Lung transplantation; Chronic lung allograft dysfunction; Bronchiolitis obliterans syndrome; Gene expression profiling; Treatment response biomarkers; Regulatory T cells

Outcome Measures

Primary Outcomes (1)

• omparison of gene expression profiles between responders and non-responders to Extracorporeal Photoapheresis (ECP)

  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.

  6 months (lung transplant cohort) and 12 months (kidney transplant cohort)

Study Arms (2)

Kidney transplant recipients receiving ECP

Adult kidney transplant recipients with biopsy-proven antibody-mediated chronic rejection who receive extracorporeal photoapheresis (ECP) as part of their treatment. Patients will be followed longitudinally with measurements of renal function, proteinuria, donor-specific antibodies, and gene expression profiling at baseline, 6 months, and 12 months.

Lung transplant recipients receiving ECP

Adult lung transplant recipients diagnosed with chronic lung allograft dysfunction (CLAD) who receive extracorporeal photoapheresis (ECP) as part of their treatment. Patients will be followed longitudinally with measurements of pulmonary function (FEV1), donor-specific antibodies, and gene expression profiling at baseline, 6 months, and 12 months.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes adult kidney and lung transplant recipients diagnosed with chronic antibody-mediated rejection (AMCR) or chronic lung allograft dysfunction (CLAD), respectively.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Pavia, 27100, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples collected for gene expression profiling and immunological analyses.

MeSH Terms

Conditions

Chronic Disease; Bronchiolitis Obliterans; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Organizing Pneumonia; Graft vs Host Disease; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 5, 2026
• Study Start: April 10, 2025
• Primary Completion: April 10, 2026
• Study Completion: April 10, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-08

Locations

IT (1)