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

NCT06351488 | Recruiting

• 1 other identifier: APHP231661
• Study Type: observational
• Target: 319
• Locations: 1 country
• Sites: 3

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.

Conditions

Kidney Transplant; Rejection

Keywords

Graft rejection; renal circulating DNA; performance of the diagnostic test

Outcome Measures

Primary Outcomes (1)

• 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

  The probability of ABMR rejection, established by kidney graft biopsy and according to the Banff 2022 classification, will be predicted with logistic regression models which will integrate the number of copies/ml of the 10 genes measured by PCR in blood or urine. and tested individually.

  At the time of the biopsy for suspicion of graft rejection

Secondary Outcomes (7)

• The area under the ROC curve of TCMR rejection prediction models according to kidney biopsy and with renal circulating DNA quantities as variables of interest

  At the time of the biopsy for suspicion of graft rejection

• The area under the ROC curve of mixed rejection prediction models according to kidney biopsy and with renal circulating DNA quantities as variables of interest

  At the time of the biopsy for suspicion of graft rejection

• The area under the ROC curve of glomerulitis-type rejection prediction models (≥g1) according to kidney biopsy and with renal circulating DNA quantities as variables of interest

  At the time of the biopsy for suspicion of graft rejection

• The area under the ROC curve of tubulitis-type rejection prediction models (≥t1) according to kidney biopsy and with renal circulating DNA quantities as variables of interest

  At the time of the biopsy for suspicion of graft rejection

• The area under the ROC curve of vascularitis-type rejection prediction models (≥v1) according to kidney biopsy and with renal circulating DNA quantities as variables of interest

  At the time of the biopsy for suspicion of graft rejection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney transplant patients eligible for a solid biopsy

You may qualify if:

• 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)

You may not qualify if:

• Under legal protection measure (curatorship or guardianship, under judicial protection).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• CGenetix: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (3)

Assistance Publique - Hôpitaux de Paris, Hôpital Necker

Paris, 75013, France

RECRUITING

Assistance Publique - Hôpitaux de Paris, Pitié-Salpêtrière hospital

Paris, 75013, France

ACTIVE NOT RECRUITING

Assistance Publique - Hôpitaux de Paris, Hôpital Tenon

Paris, 75020, France

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

two additional tubes of blood of 10 mL and 6 mL respectively as well as a urine sample of 22 mL will be collected to mainly measure the quantity of plasma DNA of renal origin circulating in the blood during an episode of graft rejection

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Pierre GALICHON, Pr

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre GALICHON, Pr

CONTACT

1 42 17 72 29; pierre.galichon@aphp.fr

Anne BISSERY

CONTACT

1 42 16 24 32; anne.bissery@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: August 21, 2024
• Primary Completion: February 11, 2026
• Study Completion: February 11, 2026
• Last Updated: December 19, 2024

Record last verified: 2024-12

Locations

FR (3)