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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Derivation cohort |
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| Validation cohort |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Kidney transplant recipients recruited in 14 French centers
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre Loupy | Paris Institute for Transplantation and Organ Regeneration | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38824959 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2020 | Jul 27, 2023 | Prot_SAP_000.pdf |
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