DE NOVO DONOR SPECIFIC ANTIBODIES AFTER KIDNEY TRANSPLANTATION: SINGLE-CENTER RETROSPECTIVE STUDY (PTV-DSAaKT)

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

Study Overview

• Status: Completed
• Conditions: Immunosuppression; Kidney Transplant; Complications
• Intervention / Treatment: Other: The dosage of dnDSA

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 Type: Observational
• Enrollment (Actual): 600

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Kidney transplant patients; 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.	Other: The dosage of dnDSA; Flow cytometric analysis using FlowPRA Screening Test and/or Luminex Single Antigen Beads class I and II- IgG (cut- positivity off = MFI> 1000)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of dnDSA in kidney transplant patients	Define the incidence of development of dnDSA in patients undergoing kidney transplantation.	• 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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Rome Tor Vergata
• Investigators: Principal Investigator: Roberta Angelico, MD, Università degli Studi di Roma "Tor Vergata"

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): May 6, 2024

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 25, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: sperimentazioni PTV 92.24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No