TreaT-Assay: the New Frontier for the Diagnosis of Acute Rejection in Kidney Transplantation

NCT06801262 | Recruiting

• 1 other identifier: TreaT2021
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Diseases; Kidney Transplant; Kidney Disease, End-Stage

Outcome Measures

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.

  5 years

Secondary Outcomes (3)

• Identification of reactive T cells involved in acute rejection

  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

  T0 (pre-transplant), T1 (first week post-transplant), T2(3 months) and T3 (6 months)

• Search for markers for acute rejection

  T0 (pre-transplant), T1 (first week post-transplant), T2(3 months) and T3 (6 months)

Eligibility Criteria

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

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• Subjects under the age of 18 years.
• Patients who are unable to make explicit their informed consent.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40135, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Basic hematochemical evaluation. These examinations belong to the type of tests normally performed for biochemical and laboratory follow-up.

MeSH Terms

Conditions

Kidney Diseases; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gaetano La Manna, MD

  IRCCS Azienza Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaetano La Manna, MD

CONTACT

+390512144577; gaetano.lamanna@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 30, 2025
• Study Start: November 10, 2022
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 30, 2025

Record last verified: 2024-12

Locations

IT (1)