Study of the Evolution of Circulating Plasma and Urinary DNA of Renal Origin in Kidney Transplant Patients

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

It has been shown that the amount of circulating donor-cell-free DNA increases in patients with transplant rejection. Quantification of single nucleotide polymorphisms (SNPs) present in circulating donor DNA currently allows for early identification of transplant rejection, but not for characterization, i.e., identification of the affected renal fraction of the graft. Recently, in healthy subjects, teams have shown that it is possible to identify the tissue origin of donor-cell-free DNA, based on the epigenetic properties of circulating DNA. CGenetix is a MedTech company developing an in vitro diagnostic medical device to identify and quantify kidney graft degradation during transplant rejection. The objective of this study is to evaluate the sensitivity of the proposed technology to detect circulating renal DNA released into the blood and urine in kidney transplant patients with or without graft rejection.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients living with a kidney transplant

• Admitted for suspected transplant rejection requiring a renal biopsy (RBB) as an indication

Locations
Other Locations
France
Chu Rouen-Bois Guillaume
RECRUITING
Rouen
Contact Information
Primary
GEOFFROY GP POULET, PhD
geoffroy.poulet@cgenetix.com
+33667772394
Time Frame
Start Date: 2024-05-30
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 250
Treatments
Kidney transplant patient eligible to a kidney biopsy
Kidney transplant patient eligible to a kidney biopsy (protocol and indication biopsy)
Related Therapeutic Areas
Sponsors
Leads: Poulet Geoffroy
Collaborators: University Hospital, Rouen

This content was sourced from clinicaltrials.gov