Kidney Transplant Failure, Renal Fibrosis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREkidney transplantation
Kidney transplant for end-stage renal disease from deceased kidney donors
Sponsors
Korea University Anam Hospital
Inje University
Ulsan University Hospital
Hallym University Medical Center
Asan Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* end-stage renal disease patients receiving kidney transplantation from deceased donors who have the ability to provide content for this study
Exclusion criteria
* multi-organ transplantation candidate or history of previous transplant, history of extra-renal solid organ or bone marrow or stem cell transplant, active infection, history of recent intoxication of alcohol or substance abuse within 24 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| kidney fibrosis | zero-day (time of transplant) | the degree of kidney graft fibrosis on zero day biopsy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kidney graft function | 6 months and 1 year post-transplant | Kidney graft function assessed with serum Creatinine, eGFR, CKD-EPI |
Countries
South Korea
Contacts
Primary ContactSung Shin, MD, PhD
Outcome results
None listed