Kidney Transplant Failure Clinical Trial
Official title:
Multicenter, Prospective Observational Study to Identify and Validate a Composite of Urinary Exosomal Biomarkers for Kidney Allograft Tubulointerstitial Fibrosis
The investigators aim to identify urinary exosomal biomarkers that represent the extent of graft fibrosis from deceased donor kidney transplantation. Urinary samples will be collected from deceased kidney donors at the time of procurement and zero-day kidney graft biopsy will be performed at the time of transplant. The association between urinary exosomes and the degree of graft fibrosis will be analyzed to identify biomarkers that represent fibrosis. The correlation between these biomarkers and graft long term outcomes will be investigated.
Interstitial fibrosis and tubular atrophy (IFTA), previously known as chronic allograft
nephropathy (CAN), is diagnosed by pathologic changes involving all parts of the renal
parenchyma and is one of the factors impacting graft survival and outcome. Currently, there
is no standard to predict allograft fibrosis status at the time of procurement. Noninvasive
biomarkers are necessary to monitor allograft status and to predict long-term outcomes.
The investigators aim to conduct a multicenter prospective study to identify urinary exosomal
biomarkers that represent the extent of graft fibrosis from deceased donor kidney
transplantation. Urinary samples will be collected from deceased kidney donors at the time of
procurement and zero-day kidney graft biopsy will be performed at the time of transplant. The
zero-day biopsy tissue will be stained with Masson's Trichrome staining, Collagen I, III, IV
immunostaining to evaluate the degree of fibrosis. Also, by ultracentrifuge, we will extract
urinary exosomes and perform proteomics analysis and RNA-sequencing. The association between
urinary exosomes and the degree of graft fibrosis will be analyzed to identify biomarkers
that represent fibrosis. The correlation between these biomarkers and graft long term
outcomes will be investigated.
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