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Multicenter, Prospective Study for Urinary Exosomal Biomarkers of Kidney Allograft Tubulointerstitial Fibrosis (UFO)

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ClinicalTrials.gov Identifier: NCT03870542
Recruitment Status : Recruiting
First Posted : March 12, 2019
Last Update Posted : September 24, 2019
Sponsor:
Collaborators:
Korea University Anam Hospital
Inje University
Ulsan University Hospital
Hallym University Medical Center
Information provided by (Responsible Party):
Sung Shin, Asan Medical Center

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.

Condition or disease Intervention/treatment
Renal Fibrosis Kidney Transplant Failure Procedure: kidney transplantation

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.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter, Prospective Observational Study to Identify and Validate a Composite of Urinary Exosomal Biomarkers for Kidney Allograft Tubulointerstitial Fibrosis
Actual Study Start Date : May 11, 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Deceased donor kidney transplantation
Patients receiving kidney transplants from deceased donor in the participating centers during the study period
Procedure: kidney transplantation
Kidney transplant for end-stage renal disease from deceased kidney donors




Primary Outcome Measures :
  1. kidney fibrosis [ Time Frame: zero-day (time of transplant) ]
    the degree of kidney graft fibrosis on zero day biopsy


Secondary Outcome Measures :
  1. Kidney graft function [ Time Frame: 6 months and 1 year post-transplant ]
    Kidney graft function assessed with serum Creatinine, eGFR, CKD-EPI


Biospecimen Retention:   Samples Without DNA
Urine samples from deceased kidney donors, zero-day kidney graft biopsy specimen, Urine and blood samples of kidney transplant recipients during a follow up of one year


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
end-stage renal disease patients receiving kidney transplantation from deceased donors who have the ability to provide content for this study, patients willing to provide content and participate in this study during the follow-up period
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03870542


Contacts
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Contact: Sung Shin, MD, PhD 82-2-3010-3964 sshin@amc.seoul.kr

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact: SUNG SHIN, Dr.       sshin@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
Korea University Anam Hospital
Inje University
Ulsan University Hospital
Hallym University Medical Center
Investigators
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Principal Investigator: Sung Shin, MD, PhD Asan Medical Center

Publications:
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Responsible Party: Sung Shin, Associate Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03870542     History of Changes
Other Study ID Numbers: S2019-0362-0001
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fibrosis
Pathologic Processes