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

NCT03870542 | Unknown

• 1 other identifier: S2019-0362-0001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Fibrosis; Kidney Transplant Failure

Outcome Measures

Primary Outcomes (1)

• kidney fibrosis

  the degree of kidney graft fibrosis on zero day biopsy

  zero-day (time of transplant)

Secondary Outcomes (1)

• Kidney graft function

  6 months and 1 year post-transplant

Study Arms (1)

Deceased donor kidney transplantation

Patients receiving kidney transplants from deceased donor in the participating centers during the study period

Procedure: kidney transplantation

Interventions

kidney transplantation PROCEDURE

Kidney transplant for end-stage renal disease from deceased kidney donors

Deceased donor kidney transplantation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• end-stage renal disease patients receiving kidney transplantation from deceased donors who have the ability to provide content for this study

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead
• Korea University Anam Hospital: collaborator
• Inje University: collaborator
• Ulsan University Hospital: collaborator
• Hallym University Medical Center: collaborator

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Related Publications (5)

• Singh T, Astor B, Zhong W, Mandelbrot D, Djamali A, Panzer S. Kidney Transplant Recipients With Primary Membranous Glomerulonephritis Have a Higher Risk of Acute Rejection Compared With Other Primary Glomerulonephritides. Transplant Direct. 2017 Oct 18;3(11):e223. doi: 10.1097/TXD.0000000000000736. eCollection 2017 Nov.

  PMID: 29184911 BACKGROUND

• Hanssen O, Erpicum P, Lovinfosse P, Meunier P, Weekers L, Tshibanda L, Krzesinski JM, Hustinx R, Jouret F. Non-invasive approaches in the diagnosis of acute rejection in kidney transplant recipients. Part I. In vivo imaging methods. Clin Kidney J. 2017 Feb;10(1):97-105. doi: 10.1093/ckj/sfw062. Epub 2016 Jul 28.

  PMID: 28643821 BACKGROUND

• Gamez-Valero A, Lozano-Ramos SI, Bancu I, Lauzurica-Valdemoros R, Borras FE. Urinary extracellular vesicles as source of biomarkers in kidney diseases. Front Immunol. 2015 Jan 30;6:6. doi: 10.3389/fimmu.2015.00006. eCollection 2015.

  PMID: 25688242 BACKGROUND

• Li B, Hartono C, Ding R, Sharma VK, Ramaswamy R, Qian B, Serur D, Mouradian J, Schwartz JE, Suthanthiran M. Noninvasive diagnosis of renal-allograft rejection by measurement of messenger RNA for perforin and granzyme B in urine. N Engl J Med. 2001 Mar 29;344(13):947-54. doi: 10.1056/NEJM200103293441301.

  PMID: 11274620 BACKGROUND

• Gonzalez-Nolasco B, Wang M, Prunevieille A, Benichou G. Emerging role of exosomes in allorecognition and allograft rejection. Curr Opin Organ Transplant. 2018 Feb;23(1):22-27. doi: 10.1097/MOT.0000000000000489.

  PMID: 29189413 BACKGROUND

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

MeSH Terms

Interventions

Kidney Transplantation

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Organ Transplantation; Transplantation; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Sung Shin, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung Shin, MD, PhD

CONTACT

82-2-3010-3964; sshin@amc.seoul.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 9, 2019
• First Posted: March 12, 2019
• Study Start: May 11, 2019
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: September 24, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)