Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients
DART-REIN
1 other identifier
observational
30
1 country
1
Brief Summary
Donor-derived cell-free DNA (dd-cfDNA) has been proposed as a potential diagnostic tool to monitor the rejection status of the kidney transplant. It has been suggested that dd-cfDNA is increasing in the blood of kidney transplant patient presenting a graft rejection. In this project, investigators proposed a different approach to predict and characterize kidney transplant rejection/dysfunction based on the quantification of epigenetic signatures present on the donor-cell-free DNA. In 2018, Moss et al. develops a deconvolution model capable of identifying the tissue origin of circulating DNA by taking advantage of its epigenetic properties. The study confirmed that the cell-free DNA circulating in healthy subjects comes mainly from blood cells and endothelial cells, but not from kidney cells. In this study, researchers investigate the evolution of blood renal-specific cell-free DNA amount in patient with chronic kidney disease before and after the transplantation surgery by testing a set of renal-specific epigenetic markers. The purpose of this study is to identify the biological noise of "native kidney" on renal-specific cell-free DNA and to compare it with signal coming from "transplanted kidney".
Trial Health
Trial Health Score
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participants targeted
Target at below P25 for all trials
Started Sep 2024
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2023
CompletedFirst Posted
Study publicly available on registry
September 7, 2023
CompletedStudy Start
First participant enrolled
September 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 9, 2026
September 24, 2025
September 1, 2025
1.8 years
August 30, 2023
September 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Amount of renal circulating cell-free DNA
The amount of renal-cell-free DNA (glomerular and tubular markers) will be measured 6 hours before the kidney transplant is performed and 12-24 hours after the kidney transplant by digital multiplex PCR
6 hours before kidney transplantation and 12 to 24 after transplantation surgery
Secondary Outcomes (3)
Estimating the inter-individual variations of the free circulating methylome of renal origin in patients with end-stage chronic insufficiency
6 hours before kidney transplantation and 12 to 24 after transplantation surgery
Identify by a method without a priori (methyl seq) specific markers of acute renal injury in terms of epigenetic signature
6 hours before kidney transplantation and 12 to 24 after transplantation surgery
Study the statistical association between the presence of free circulating methylated sequences of renal origin and the resumption of graft function
7 day after the transplant
Interventions
The extracted circulating DNA will be extracted and converted using the methylation kit. Finally, circulating DNA will be analyzed using the PCR mix developed by CGenetix, quantifying tubular and glomerular biomarkers (patented technology).
Eligibility Criteria
Adult subjects with end-stage renal disease about to receive a kidney transplant from a deceased donor.
You may qualify if:
- Age ≥ 18 years old
- With end-stage renal failure
- Summoned for a kidney transplant at Pitié Salpêtrière Hospital
- Having been informed of the study and not objecting to the study having given free and informed written consent for the genetic analysis
- Benefiting from a social security scheme (excluding AME)
You may not qualify if:
- Under legal protective measures (curatorship or guardianship, under judicial safeguard).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pitié-Salpétriêre Hospital
Paris, Île-de-France Region, 75013, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2023
First Posted
September 7, 2023
Study Start
September 2, 2024
Primary Completion (Estimated)
July 2, 2026
Study Completion (Estimated)
July 9, 2026
Last Updated
September 24, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
- Access Criteria
- Researchers who provide a methodologically sound proposal.
The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l\'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.