Donor Derived Cell-free DNA and Rejection of Kidney Allografts

Study Overview
=================
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.

Official Title
-----------------
Donor Derived Cell-free DNA and Rejection of Kidney Allografts

Conditions
-----------------
Kidney Rejection Transplant

Intervention / Treatment
-----------------
* Diagnostic Test: Donor-derived cell-free DNA


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Derivation cohort<br> | Diagnostic Test: Donor-derived cell-free DNA<br>* Cell-free DNA (cfDNA) is fragmented extracellular DNA released in the bloodstream from cells undergoing apoptosis or necrosis. In transplantation, donor-derived cfDNA (dd-cfDNA) is detected in the blood of kidney recipients and has been proposed as a noninvasive biomarker to detect rejection. One additional blood sample will be collected and dd-cfDNA levels will be centrally analyzed.<br>|
| Validation cohort<br> | Diagnostic Test: Donor-derived cell-free DNA<br>* Cell-free DNA (cfDNA) is fragmented extracellular DNA released in the bloodstream from cells undergoing apoptosis or necrosis. In transplantation, donor-derived cfDNA (dd-cfDNA) is detected in the blood of kidney recipients and has been proposed as a noninvasive biomarker to detect rejection. One additional blood sample will be collected and dd-cfDNA levels will be centrally analyzed.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of biopsy-proven allograft rejection at the time of dd-cfDNA measurement | 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. | 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. |