Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03870542
Study type Observational
Source Asan Medical Center
Contact Sung Shin, MD, PhD
Phone 82-2-3010-3964
Email sshin@amc.seoul.kr
Status Recruiting
Phase
Start date May 11, 2019
Completion date April 2022

See also
  Status Clinical Trial Phase
Withdrawn NCT04560582 - Immunosuppression Reduction in Failed Allograft Guided by cfDNA
Withdrawn NCT04216303 - Optimal A1c Control in Post Liver or Combined Liver and Kidney Transplant Recipients Who Have Diabetes Mellitus
Recruiting NCT03689075 - Extended Release Versus Immediate Release Tacrolimus Following Renal Allograft Failure to Reduce Allosensitisation Phase 4
Recruiting NCT05788276 - Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys? Phase 4
Active, not recruiting NCT04882254 - Normothermic Machine Perfusion: an Additional Value for Kidney Transplant Outcomes? Phase 2
Completed NCT04918199 - Human Versus Computer-based Predictions of Long Allograft Survival
Active, not recruiting NCT04897438 - Donor-derived Cell-free DNA for Early Diagnosis of Antibody-mediated Rejection N/A
Enrolling by invitation NCT05285878 - Fingolimod for the Abrogation of Interstitial Fibrosis and Tubular Atrophy Following Kidney Transplantation Phase 2
Recruiting NCT04226859 - Trajectories of Glomerular Filtration Rate and Progression to End Stage Renal Disease After Kidney Transplantation
Recruiting NCT06056518 - Investigating the Impact of AI on Shared Decision Making in Post-kidney Transplant Care N/A
Completed NCT05619679 - A Clinical Practice Snapshot on Pediatric Kidney Transplantation
Completed NCT06020534 - Aortoiliac Stenosis in Kidney Transplantation
Active, not recruiting NCT02960802 - Kidney Transplantation and Renal and Myocardial Perfusion N/A
Completed NCT05200949 - SURGICAL EXPERIENCE ON RENAL TRANSPLANT COMPLICATIONS
Completed NCT04258891 - Multidimensional System to Dynamically Predict Graft Survival After Kidney Transplantation
Recruiting NCT06186843 - Plant-based Diet for Kidney Transplant Recipients N/A
Active, not recruiting NCT04154267 - Protocol Biopsies in High-risk Renal Transplant Recipients N/A