Donor Derived Cell-free DNA and Rejection of Kidney Allografts

Completed

• Conditions: Kidney Rejection Transplant
• Interventions: Diagnostic Test: Donor-derived cell-free DNA

• Registration Number: NCT05995379
• Lead Sponsor: Paris Translational Research Center for Organ Transplantation

Brief Summary

To assess the association of dd-cfDNA with the presence, activity and severity of allograft rejection, and determine whether dd-cfDNA adds value to standard of care monitoring parameters in detecting kidney allograft rejection.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-21
• Primary Completion: 2022-08-09
• Study Completion: 2022-08-09
• Study First Submitted: 2023-07-28
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-07
• Last Update Submitted: 2023-08-07
• Study First Posted: 2023-08-16
• Last Update Posted: 2023-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

• Recipients transplanted from a deceased or living donor, who undergone a kidney allograft biopsy with clinical, biological, histological and immunological data.
• Written informed consent at the time of transplantation for the center database

Exclusion Criteria

• Combined organ transplantation
• Pregnant women
• Bone marrow transplant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Derivation cohort	Donor-derived cell-free DNA	-
Validation cohort	Donor-derived cell-free DNA	-

Primary Outcome Measures

Name	Time	Method
The occurrence of biopsy-proven allograft rejection at the time of dd-cfDNA measurement	The allograft biopsies will be performed at 3 months and 1 year after transplant and/or in for cause biopsies performed at any time post transplantation in unstable patients.	Biopsy-proven rejection refers to the confirmation of rejection through the examination of kidney allograft tissue obtained from a biopsy procedure. This includes different types of rejection, which are antibody-mediated rejection, T-cell-mediated rejection, and mixed rejection. All the allograft biopsies will be classified according to the most recognized classification (Banff 2019 classification), which provides standardized criteria for the diagnosis and the characterization of the different types of rejection.; To evaluate the association between dd-cfDNA and the occurrence of rejection, measurement of dd-cfDNA will be done at the time of each biopsy.