Detection of Circulating Kidney DNA in Kidney Transplant Patients Facing an Episode of Graft Rejection

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT06351488
Status
Recruiting
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Conditions

  • Kidney Transplant
  • Rejection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

In France, 3,500 kidney transplants are carried out per year; and 40,000 people succeed in 2019 with a kidney transplant. Despite regular medical monitoring, nearly 30% of transplant patients will develop rejection. Currently, only solid biopsy of the graft makes it possible to establish the diagnosis of graft rejection, and to characterize its cellular origin based on the Banff classification. Several studies have shown the possibility of identifying the tissue origin of DNA circulating in the blood, in healthy subjects, on the basis of the epigenetic properties of circulating DNA. In addition, in kidney transplant subjects, an increase in the quantity of circulating DNA originating from the graft in the blood and urine has been shown as well as an increase in urinary chemokine levels during renal dysfunction (notably dismiss). Thus, the company CGenetix in partnership with INSERM units 1155 and 1151 is developing a method to identify and characterize kidney transplant rejection early, through the detection of epigenetic biomarkers on circulating DNA targeting different fractions of the kidney (glomerular, tubular, peritubular capillary and vascular). The main objective is to study the diagnostic performance of the quantity of DNA of renal origin in kidney transplant patients in the blood and in the urine (expressed in copies/ml) for the diagnosis of type Rejection mediated by kidneys. antibody (ABMR) established by kidney graft biopsy (gold standard) and according to the Banff 2022 classification.

Key Dates

First listed
Apr 8, 2024
Start date
Aug 21, 2024
Status verified
Dec 2024
Primary completion
Feb 11, 2026
Completion
Feb 11, 2026

Study Design

Enrollment
319 participants (estimated)

Primary Outcome Measure

The area under the ROC curve of ABMR rejection prediction models according to kidney biopsy and with renal circulating DNA quantities as variables of interest [ Time Frame: At the time of the biopsy for suspicion of graft rejection ]

Central Contacts

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