TreaT-Assay: the New Frontier for the Diagnosis of Acute Rejection in Kidney Transplantation
Recruiting · NCT06801262 · Observational (researchers observe without assigning treatment) · Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
1 location listed.
- IRCCS Azienda Ospedaliero-Universitaria di Bologna - Bologna, Italy