NCT06351488 Detection of Circulating Kidney DNA in Kidney Transplant Patients Facing an Episode of Graft Rejection
| NCT ID | NCT06351488 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Kidney Transplant |
| Study Type | OBSERVATIONAL |
| Enrollment | 319 participants |
| Start Date | 2024-08-21 |
| Primary Completion | 2026-02-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 319 participants in total. It began in 2024-08-21 with a primary completion date of 2026-02-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 ans * Patient living with at least one functioning kidney graft * Summoned to perform a kidney biopsy for cause/indication at the Pitié Salpêtrière Hospital or at the Necker Hospital * Having been informed of the study and not opposing the study * Benefiting from a social security system (excluding AME) Exclusion Criteria: * Under legal protection measure (curatorship or guardianship, under judicial protection).
Contact & Investigator
Pierre GALICHON, Pr
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT06351488 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Kidney Transplant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06351488 currently recruiting?
Yes, NCT06351488 is actively recruiting participants. Contact the research team at pierre.galichon@aphp.fr for enrollment information.
Where is the NCT06351488 trial being conducted?
This trial is being conducted at Paris, France, Paris, France, Paris, France.
Who is sponsoring the NCT06351488 clinical trial?
NCT06351488 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Pierre GALICHON, Pr at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 319 participants.
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