Donor Derived Cell-free DNA and Rejection of Kidney Allografts

NCT05995379 | Completed

• 1 other identifier: ddcfDNA_study001
• Study Type: observational
• Target: 2,500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Kidney Rejection Transplant

Outcome Measures

Primary Outcomes (1)

• The occurrence of biopsy-proven allograft rejection at the time of dd-cfDNA measurement

  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.

  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.

Study Arms (2)

Derivation cohort

Diagnostic Test: Donor-derived cell-free DNA

Validation cohort

Diagnostic Test: Donor-derived cell-free DNA

Interventions

Donor-derived cell-free DNA DIAGNOSTIC_TEST

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.

Derivation cohort; Validation cohort

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney transplant recipients recruited in 14 French centers

You may qualify if:

• 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

You may not qualify if:

• Combined organ transplantation
• Pregnant women
• Bone marrow transplant

Sponsors & Collaborators

• Paris Translational Research Center for Organ Transplantation: lead

Related Publications (1)

• Aubert O, Ursule-Dufait C, Brousse R, Gueguen J, Racape M, Raynaud M, Van Loon E, Pagliazzi A, Huang E, Jordan SC, Chavin KD, Gupta G, Kumar D, Alhamad T, Anand S, Sanchez-Garcia J, Abdalla BA, Hogan J, Garro R, Dadhania DM, Jain P, Mandelbrot DA, Naesens M, Dandamudi R, Dharnidharka VR, Anglicheau D, Lefaucheur C, Loupy A. Cell-free DNA for the detection of kidney allograft rejection. Nat Med. 2024 Aug;30(8):2320-2327. doi: 10.1038/s41591-024-03087-3. Epub 2024 Jun 2.

  PMID: 38824959 DERIVED

Study Officials

• Alexandre Loupy

  Paris Institute for Transplantation and Organ Regeneration

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 16, 2023
• Study Start: September 21, 2011
• Primary Completion: August 9, 2022
• Study Completion: August 9, 2022
• Last Updated: August 16, 2023

Record last verified: 2023-08