Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425497
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2024-05-17
Brief Title:
DE NOVO DONOR SPECIFIC ANTIBODIES AFTER KIDNEY TRANSPLANTATION SINGLE-CENTER RETROSPECTIVE STUDY
Sponsor:
University of Rome Tor Vergata
Organization:
University of Rome Tor Vergata
Study Overview
Official Title:
DE NOVO DONOR SPECIFIC ANTIBODIES AFTER KIDNEY TRANSPLANTATION SINGLE-CENTER RETROSPECTIVE STUDY
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PTV-DSAaKT
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 UOC 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 UOC 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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None