A Prospective Multicenter Trial to Evaluate Urinary Metabolomics for Non-invasive Detection of Renal Allograft Rejection (PARASOL) : Study Protocol and Patient Recruitment
Banas, Miriam C. (University Hospital Regensburg)
Böhmig, Georg A. (Medical University of Vienna)
Viklicky, Ondrej (Institute for Clinical and Experimental Medicine)
Rostaing, Lionel P. (Grenoble Alpes University)
Jouve, Thomas (Grenoble University Hospital)
Guirado, Luis (Institut d'Investigació Biomèdica Sant Pau)
Facundo, Carme (Institut d'Investigació Biomèdica Sant Pau)
Bestard, Oriol (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Gröne, Hermann-Josef (Philipps-University)
Kobayashi, Kazuhiro (University of Marburg)
Hanzal, Vladimir (Institute for Clinical and Experimental Medicine (IKEM))
Putz, Franz Josef (University Hospital Regensburg)
Zecher, Daniel (University Hospital Regensburg)
Bergler, Tobias (University Hospital Regensburg)
Neumann, Sindy (numares AG)
Rothe, Victoria (numares AG)
Schwäble Santamaria, Amauri G. (numares AG)
Schiffer, Eric (numares AG)
Banas, Bernhard (University Hospital Regensburg)
Universitat Autònoma de Barcelona

Data:	2022
Resum:	Background: In an earlier monocentric study, we have developed a novel non-invasive test system for the prediction of renal allograft rejection, based on the detection of a specific urine metabolite constellation. To further validate our results in a large real-world patient cohort, we designed a multicentric observational prospective study (PARASOL) including six independent European transplant centers. This article describes the study protocol and characteristics of recruited better patients as subjects. Methods: Within the PARASOL study, urine samples were taken from renal transplant recipients when kidney biopsies were performed. According to the Banff classification, urine samples were assigned to a case group (renal allograft rejection), a control group (normal renal histology), or an additional group (kidney damage other than rejection). Results: Between June 2017 and March 2020, 972 transplant recipients were included in the trial (1,230 urine samples and matched biopsies, respectively). Overall, 237 samples (19. 3%) were assigned to the case group, 541 (44. 0%) to the control group, and 452 (36. 7%) samples to the additional group. About 65. 9% were obtained from male patients, the mean age of transplant recipients participating in the study was 53. 7 ± 13. 8 years. The most frequently used immunosuppressive drugs were tacrolimus (92. 8%), mycophenolate mofetil (88. 0%), and steroids (79. 3%). Antihypertensives and antidiabetics were used in 88. 0 and 27. 4% of the patients, respectively. Approximately 20. 9% of patients showed the presence of circulating donor-specific anti-HLA IgG antibodies at time of biopsy. Most of the samples (51. 1%) were collected within the first 6 months after transplantation, 48. 0% were protocol biopsies, followed by event-driven (43. 6%), and follow-up biopsies (8. 5%). Over time the proportion of biopsies classified into the categories Banff 4 (T-cell-mediated rejection [TCMR]) and Banff 1 (normal tissue) decreased whereas Banff 2 (antibody-mediated rejection [ABMR]) and Banff 5I (mild interstitial fibrosis and tubular atrophy) increased to 84. 2 and 74. 5%, respectively, after 4 years post transplantation. Patients with rejection showed worse kidney function than patients without rejection. Conclusion: The clinical characteristics of subjects recruited indicate a patient cohort typical for routine renal transplantation all over Europe. A typical shift from T-cellular early rejections episodes to later antibody mediated allograft damage over time after renal transplantation further strengthens the usefulness of our cohort for the evaluation of novel biomarkers for allograft damage.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Kidney transplant rejection ; Urinary metabolites ; Biomarker ; NMR-spectroscopy ; Non-invasive test
Publicat a:	Frontiers in Medicine, Vol. 8 (january 2022) , ISSN 2296-858X

DOI: 10.3389/fmed.2021.780585
PMID: 35071266

13 p, 1.3 MB

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