DE NOVO DONOR SPECIFIC ANTIBODIES AFTER KIDNEY TRANSPLANTATION: SINGLE-CENTER RETROSPECTIVE STUDY

Completed

• Conditions: Immunosuppression; Kidney Transplant; Complications
• Interventions: Other: The dosage of dnDSA

• Registration Number: NCT06425497
• Lead Sponsor: University of Rome Tor Vergata

Brief Summary

To investigate the variations of Donor Specific Antibodies in kidney transplant patients based on the type of immunosuppressive therapy adopted and immunosuppressive blood levels.

Detailed Description

Retrospective observational monocentric study at the U.O.C. of Hepatobiliary Surgery and Transplants of Tor Vergata Polyclinic. All kidney transplant patients in the indicated study period will be enrolled and followed at the U.O.C. clinic.

For each patient, demographic, transplant and post-transplant data will be collected. In the latter, data relating to dnDSA will be registered, searching for a possible triggering cause at the anamnestic level.

The dosage of dnDSA is performed in common clinical practice in a routine manner in all patients undergoing kidney transplant, using the method "Flow cytometric analysis using FlowPRA Screening Test and/or Luminex Single Antigen Beads class I and II- IgG (cut- positivity off = MFI\> 1000)".

The blood dosage of the immunosuppressor is measured during routine checks and a comparison is made between Tacrolimus-based immunosuppressive therapy and other immunosuppressive therapy, highlighting the differences in the risk of developing dnDSA and in graft and patient survival.

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2023-07-31
• Status Verified: 2024-05
• Study Completion: 2024-05-06
• Study First Submitted: 2024-05-17
• Study First Submitted QC: 2024-05-17
• Study First Posted: 2024-05-22
• Last Update Submitted: 2024-05-25
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Patients,both male and female over the age of 18
• Patients with at least one year of follow-up

Exclusion Criteria

• Combined liver-kidney or pancreas-kidney transplants
• Re-transplants
• Patients with follow-up less than one year

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Kidney transplant patients	The dosage of dnDSA	The study population will be composed by patients who underwent a kidney transplant, single or double, from a deceased or living donor, from 01/01/2010 to 07/31/2023 at the U.O.C. of the Hepatobiliary Surgery and Transplants of the Tor Vergata Polyclinic, with at least one year of post-transplant follow-up.

Primary Outcome Measures

Name	Time	Method
Development of dnDSA in kidney transplant patients	• Pre-transplant • Baseline (I PODs) • At one week • At one month • At 3 months • At 6 months • At one year • At 5 years old • At 10 years old	Define the incidence of development of dnDSA in patients undergoing kidney transplantation.

Secondary Outcome Measures

Name	Time	Method
Patient survival	5 and 10 years	Patient survival at 5 and 10 years
Blood dosage levels of post-transplant immunosuppressive drugs	• At one week • At one month • At 3 months • At 6 months • At one year • At 5 years old • At 10 years old	Blood dosage levels of post-transplant immunosuppressive drugs (tacrolemia, ciclosporinemia, everolemia, sirolemia);
Graft survival	5 and 10 years	Graft survival At 5 and 10 years
Donor-recipient HLA mismatch	Pre-transplant	Donor-recipient HLA mismatch