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

Immunosuppression Clinical Trial

— PTV-DSAaKT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06425497
• Other study ID #: sperimentazioni PTV 92.24
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: May 6, 2024

Study information

• Verified date: May 2024
• Source: University of Rome Tor Vergata
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: May 6, 2024
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Immunosuppression
• Kidney Transplant; Complications

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Graft survival	Graft survival At 5 and 10 years	5 and 10 years
Secondary	Patient survival	Patient survival at 5 and 10 years	5 and 10 years
Secondary	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
Secondary	Donor-recipient HLA mismatch	Donor-recipient HLA mismatch	Pre-transplant