Clinical trial NCT06425497: DE NOVO DONOR SPECIFIC ANTIBODIES AFTER KIDNEY TRANSPLANTATION: SINGLE-CENTER RETROSPECTIVE STUDY
Official title: DE NOVO DONOR SPECIFIC ANTIBODIES AFTER KIDNEY TRANSPLANTATION: SINGLE-CENTER RETROSPECTIVE STUDY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant; Complications
Immunosuppression
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 600
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Development of dnDSA in kidney transplant patients
timeFrame: • 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 outcomes:
measure: Graft survival
timeFrame: 5 and 10 years
measure: Patient survival
timeFrame: 5 and 10 years
measure: Blood dosage levels of post-transplant immunosuppressive drugs
timeFrame: • At one week • At one month • At 3 months • At 6 months • At one year • At 5 years old • At 10 years old
measure: Donor-recipient HLA mismatch
timeFrame: Pre-transplant
Other outcomes:
Locations:
Study officials:
affiliation: Università degli studi di Roma Tor Vergata
name: Roberta Angelico, MD
role: PRINCIPAL_INVESTIGATOR
References: