## Protocol Section
### Identification Module
**NCT ID:** NCT06425497

**Acronym:** PTV-DSAaKT

**Brief Title:** 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

#### Organization Study ID Info
**ID:** sperimentazioni PTV 92.24
#### Organization
**Class:** OTHER
**Full Name:** University of Rome Tor Vergata
### Status Module
#### Completion Date
**Date:** 2024-05-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-25

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-07-31

**Type:** ACTUAL

#### Start Date
**Date:** 2010-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Rome Tor Vergata

#### Responsible Party

**Investigator Affiliation:** University of Rome Tor Vergata

**Investigator Full Name:** Roberta Angelico

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Kidney Transplant; Complications

- Immunosuppression

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 600

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: The dosage of dnDSA

**Label:** Kidney transplant patients

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Kidney transplant patients

**Description:** Flow cytometric analysis using FlowPRA Screening Test and/or Luminex Single Antigen Beads class I and II- IgG (cut- positivity off = MFI\> 1000)

**Name:** The dosage of dnDSA

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Define the incidence of development of dnDSA in patients undergoing kidney transplantation.

**Measure:** Development of dnDSA in kidney transplant patients

**Time Frame:** • 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

**Description:** Graft survival At 5 and 10 years

**Measure:** Graft survival

**Time Frame:** 5 and 10 years

**Description:** Patient survival at 5 and 10 years

**Measure:** Patient survival

**Time Frame:** 5 and 10 years

**Description:** Blood dosage levels of post-transplant immunosuppressive drugs (tacrolemia, ciclosporinemia, everolemia, sirolemia);

**Measure:** Blood dosage levels of post-transplant immunosuppressive drugs

**Time Frame:** • At one week • At one month • At 3 months • At 6 months • At one year • At 5 years old • At 10 years old

**Description:** Donor-recipient HLA mismatch

**Measure:** Donor-recipient HLA mismatch

**Time Frame:** Pre-transplant

### Eligibility Module

**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

**Minimum Age:** 19 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Università degli Studi di Roma "Tor Vergata"

**Name:** Roberta Angelico, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
