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Donor Derived Cell-free DNA and Rejection of Kidney Allografts

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ClinicalTrials.gov Identifier: NCT05995379
Recruitment Status : Completed
First Posted : August 16, 2023
Last Update Posted : August 16, 2023
Sponsor:
Information provided by (Responsible Party):
Paris Translational Research Center for Organ Transplantation

Study Description
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Brief Summary:
To assess the association of dd-cfDNA with the presence, activity and severity of allograft rejection, and determine whether dd-cfDNA adds value to standard of care monitoring parameters in detecting kidney allograft rejection.

Condition or disease Intervention/treatment
Kidney Rejection Transplant Diagnostic Test: Donor-derived cell-free DNA

Study Design
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Study Type : Observational
Actual Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Donor Derived Cell-free DNA and Rejection of Kidney Allografts
Actual Study Start Date : September 21, 2011
Actual Primary Completion Date : August 9, 2022
Actual Study Completion Date : August 9, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Organ Donation

Groups and Cohorts
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Group/Cohort Intervention/treatment
Derivation cohort Diagnostic Test: Donor-derived cell-free DNA

Cell-free DNA (cfDNA) is fragmented extracellular DNA released in the bloodstream from cells undergoing apoptosis or necrosis. In transplantation, donor-derived cfDNA (dd-cfDNA) is detected in the blood of kidney recipients and has been proposed as a noninvasive biomarker to detect rejection.

One additional blood sample will be collected and dd-cfDNA levels will be centrally analyzed.
Validation cohort Diagnostic Test: Donor-derived cell-free DNA

Cell-free DNA (cfDNA) is fragmented extracellular DNA released in the bloodstream from cells undergoing apoptosis or necrosis. In transplantation, donor-derived cfDNA (dd-cfDNA) is detected in the blood of kidney recipients and has been proposed as a noninvasive biomarker to detect rejection.

One additional blood sample will be collected and dd-cfDNA levels will be centrally analyzed.


Outcome Measures
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Primary Outcome Measures :
  1. The occurrence of biopsy-proven allograft rejection at the time of dd-cfDNA measurement [ Time Frame: The allograft biopsies will be performed at 3 months and 1 year after transplant and/or in for cause biopsies performed at any time post transplantation in unstable patients. ]

    Biopsy-proven rejection refers to the confirmation of rejection through the examination of kidney allograft tissue obtained from a biopsy procedure. This includes different types of rejection, which are antibody-mediated rejection, T-cell-mediated rejection, and mixed rejection. All the allograft biopsies will be classified according to the most recognized classification (Banff 2019 classification), which provides standardized criteria for the diagnosis and the characterization of the different types of rejection.

    To evaluate the association between dd-cfDNA and the occurrence of rejection, measurement of dd-cfDNA will be done at the time of each biopsy.



Eligibility Criteria
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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Kidney transplant recipients recruited in 14 French centers
Criteria

Inclusion Criteria:

  • Recipients transplanted from a deceased or living donor, who undergone a kidney allograft biopsy with clinical, biological, histological and immunological data.
  • Written informed consent at the time of transplantation for the center database

Exclusion Criteria:

  • Combined organ transplantation
  • Pregnant women
  • Bone marrow transplant
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05995379


Sponsors and Collaborators
Paris Translational Research Center for Organ Transplantation
Investigators
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Principal Investigator: Alexandre Loupy Paris Institute for Transplantation and Organ Regeneration
  Study Documents (Full-Text)

Documents provided by Paris Translational Research Center for Organ Transplantation:
Study Protocol and Statistical Analysis Plan  [PDF] March 1, 2020

More Information
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Responsible Party: Paris Translational Research Center for Organ Transplantation
ClinicalTrials.gov Identifier: NCT05995379    
Other Study ID Numbers: ddcfDNA_study001
First Posted: August 16, 2023    Key Record Dates
Last Update Posted: August 16, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No