Donor Derived Cell-free DNA and Rejection of Kidney Allografts

Paris Translational Research Center for Organ Transplantation

Status: Completed

Conditions: Kidney Rejection Transplant

Treatments: Diagnostic Test: Donor-derived cell-free DNA

Study type: Observational

Funder types: Other

Identifiers

NCT05995379

ddcfDNA_study001

Details and patient eligibility

About

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.

Enrollment: 2,500 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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

Trial design

2,500 participants in 2 patient groups

Derivation cohort

Treatment:

Diagnostic Test: Donor-derived cell-free DNA

Validation cohort

Treatment:

Diagnostic Test: Donor-derived cell-free DNA