Study of the Plasma and Urinary cfDNA of in Kidney Transplant Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPoulet Geoffroy
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients living with a kidney transplant
Admitted for suspected transplant rejection requiring a renal biopsy (RBB) as an indication
Disqualifiers
Patients with cognitive and mental disorders rendering them unable to express their non-opposition to participation in the study
Not covered by a social security system.
Under guardianship or guardianship, or under legal protection.
Patients who have expressed their refusal to participate in the study
Trial population
Patients living with a kidney transplant eligible for a protocol biopsy or indication for suspected graft rejection
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
250 Participants
are grouped into 1 trial groupGroup A: Kidney transplant patient eligible to a kidney biopsy
Trial outcomes
Primary outcomes
1
Renal cell-free DNA in plasma and urine
Quantification of Renal-cell-free DNA in plasma and urine exprimed in copy / mL of biological fluid
Time frame
24 HoursSponsors and contacts
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Source ClinicalTrials.gov