An observational study in Kidney Diseases, Kidney Transplant and Kidney Disease, End-Stage, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-30.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
Kidney transplantation is the standard therapy for end-stage renal disease. Acute rejection (AR) or chronic rejection along with reactive donor immunity, which counteracts organ acceptance, are among the greatest medical challenges in transplantation.
In the posttransplantation setting, immunosuppressive drugs are administered to control or prevent immune reactions; however, the therapies have serious side effects. Retrospective studies have shown heterogeneous risk profiles with respect to post-transplant complications, such as AR or infection, suggesting the introduction of an individualized immunosuppressive regimen2,3,4. Biomarkers are needed for such individual therapies to discriminate between patients with different risk profiles.
Kidney transplantation is the standard therapy for end-stage renal disease. Acute rejection (AR) or chronic rejection along with reactive donor immunity, which counteracts organ acceptance, are among the greatest medical challenges in transplantation.
In the posttransplantation setting, immunosuppressive drugs are administered to control or prevent immune reactions; however, the therapies have serious side effects. Retrospective studies have shown heterogeneous risk profiles with respect to post-transplant complications, such as AR or infection, suggesting the introduction of an individualized immunosuppressive regimen. Biomarkers are needed for such individual therapies to discriminate between patients with different risk profiles.
The presence of donor reactive T-cells pre and post kidney transplantation correlates with acute rejection and with reduced allograft survival1,7,8. For these reasons, a specific and sensitive assay has been developed for in-depth monitoring and characterization of reactive T cells from allografts: the Transplant reactive T-cells-assay (TreaT assay). For the latter, donor TECs, obtained from the recipient's urine by selective catherization of the transplanted kidney, a useful and renewable antigenic source for stimulation of recipient PBMCs, are used as the stimulating source.
The TreaT assay, compared with previous tests, has the advantages of unlimited availability of starting sample, easy in implementation, inexpensive and superior performance. Pilot studies, have obtained encouraging data on the test's applicability in patients with early acute rejection and prediction of post-transplant eGFR. In addition, this approach provides insight into the biology of alloreactive immune cells specifically, the immunological interaction with donor/recipient in post-transplantation. Therefore, it could help guide a personalized pharmacological approach of therapy in the future of kidney transplantation.
The study is non-interventional and requires obtaining clinical data from recruited subjects and blood and urine samples. Therefore, no added risk to the subjects involved is expected.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 150 is below the median of 192 across 1,033 observational studies indexed under Kidney Diseases.
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All patients undergoing living and cadaveric kidney transplantation will be considered, afferent to the Department of Nephrology at St. Orsola Hospital, Pavilion 15, who meet the criteria of inclusion.
Inclusion Criteria:
Inclusion criteria for study patients group B
Exclusion Criteria:
Exclusion criteria for patients in study group B
Create the TreaT test
The study aims to create a pivotal tool (the TreaT test) by collecting and culturing PBMCs and TECs from kidney transplant recipient.
Time frame: 5 years
Identification of reactive T cells involved in acute rejection
Assess the various lymphocyte subpopulations: Th1, Th2, Th17, natural killer, Treg, Memory, monocytes and B cells and the production of pro- and anti-inflammatory cytokines following co-culture with TEC
Time frame: T0 (pre-transplant), T1 (first week post-transplant), T2(3 months) and T3 (6 months)
Understand the immunological and molecular basis of acute rejection and predictive markers
Biomarkers, via TreaT assay, with high positive and/or negative predictive value, sensitive and minimally invasive will be sought. The strategy, termed "unbiased," implemented for the identification of new biomarkers, is the screening of proteins, genes, etc. not based on any specific hypothesis except that through these assays it will be possible to identify elements capable of differentiating groups of subjects with distinct clinical phenotypes.
Time frame: T0 (pre-transplant), T1 (first week post-transplant), T2(3 months) and T3 (6 months)
Search for markers for acute rejection
Evaluation of the correlation of potential instrumental, laboratory markers (lymphocyte subpopulations, plasma, serum and urinary concentrations of previously identified predictive markers) with the presence and type of histologically demonstrated acute rejection and specific histologic lesions (according to Banff 2017 classification).
Time frame: T0 (pre-transplant), T1 (first week post-transplant), T2(3 months) and T3 (6 months)
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IRCCS Azienda Ospedaliero-Universitaria di Bologna