TreaT-Assay: the New Frontier for the Diagnosis of Acute Rejection in Kidney Transplantation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Inclusion criteria for subjects in group A Healthy adult subjects who will be selected from blood donors belonging to the Metropolitan Immunohematology and Transfusion Medicine Service. It should be noted that for subjects belonging to group A, informed consent is not required as the samples are provided in anonymous manner and completely unrelated to the patient.
Inclusion criteria for study patients group B
Subjects undergoing living or cadaveric kidney transplantation afferent to the O.U. of Nephrology, Dialysis and Renal Transplantation, St. Orsola Hospital, Pavilion 15.
Patients who intend to participate in the study.
Disqualifiers
Exclusion criteria for subjects in group A None
Exclusion criteria for patients in study group B
Subjects under the age of 18 years.
Patients who are unable to make explicit their informed consent.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
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)2
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)3
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)Sponsors and contacts
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Source ClinicalTrials.gov