Urinary Transglutaminase 2 as a Biomarker for Kidney Allograft Fibrosis
NCT ID: NCT03487861
Last Updated: 2018-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1000 participants
OBSERVATIONAL
2017-08-29
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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observational(urinary biomarker for kidney allograft fibrosis)
After an informed consent is obtained, urine specimens will be collected prospectively before kidney transplantation (if available) and 3rd and 7th day, 1st, 3rd, and 6th month post-transplant. About 35\~50ml of urine sample is collected from each patient. For each urine specimen, 0.5 ml of a protease inhibitor mixture (5mM 4-(2-animoethyl) benzensulfonyl fluoride hydrolchloride, 2 μM Leupeptin-hemisulfate, and 3.3 mM Sodium azide) is added. To remove urinary sediments including whole cells, large membrane particles, and other debris, urine specimens are centrifuged at a rate of 4000 rpm for 15 minutes at 4 ℃. An aliquot of supernatant is stored at -80 ℃ until use. Urinary biomarkers including transglutaminase 2 are quantified using ELISA or CBA. In addition, urinary exosomes are isolated and analyzed. When a for-cause biopsy is done for some patients, the correlation between biomarkers and pathologic diagnosis will be assessed.
Eligibility Criteria
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Inclusion Criteria
* kidney transplant recipients who take immunosuppressants regularly
* kidney transplant recipients who voluntarily agree to participate in this trial
Exclusion Criteria
* kidney transplant recipients with active infection
* kidney transplant recipients with alcohol or drug addiction
18 Years
70 Years
ALL
No
Sponsors
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Asan Medical Center
OTHER
Responsible Party
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Sung Shin
Associate professor
Principal Investigators
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SUNG SHIN, MD, PhD
Role: STUDY_CHAIR
Asan Medical Center
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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SUNG SHIN, Dr.
Role: primary
References
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Meguid El Nahas A, Bello AK. Chronic kidney disease: the global challenge. Lancet. 2005 Jan 22-28;365(9456):331-40. doi: 10.1016/S0140-6736(05)17789-7.
Lorand L, Graham RM. Transglutaminases: crosslinking enzymes with pleiotropic functions. Nat Rev Mol Cell Biol. 2003 Feb;4(2):140-56. doi: 10.1038/nrm1014.
Oh K, Park HB, Byoun OJ, Shin DM, Jeong EM, Kim YW, Kim YS, Melino G, Kim IG, Lee DS. Epithelial transglutaminase 2 is needed for T cell interleukin-17 production and subsequent pulmonary inflammation and fibrosis in bleomycin-treated mice. J Exp Med. 2011 Aug 1;208(8):1707-19. doi: 10.1084/jem.20101457. Epub 2011 Jul 11.
Kojima S, Nara K, Rifkin DB. Requirement for transglutaminase in the activation of latent transforming growth factor-beta in bovine endothelial cells. J Cell Biol. 1993 Apr;121(2):439-48. doi: 10.1083/jcb.121.2.439.
Scarpellini A, Germack R, Lortat-Jacob H, Muramatsu T, Billett E, Johnson T, Verderio EA. Heparan sulfate proteoglycans are receptors for the cell-surface trafficking and biological activity of transglutaminase-2. J Biol Chem. 2009 Jul 3;284(27):18411-23. doi: 10.1074/jbc.M109.012948. Epub 2009 Apr 27.
Scarpellini A, Huang L, Burhan I, Schroeder N, Funck M, Johnson TS, Verderio EA. Syndecan-4 knockout leads to reduced extracellular transglutaminase-2 and protects against tubulointerstitial fibrosis. J Am Soc Nephrol. 2014 May;25(5):1013-27. doi: 10.1681/ASN.2013050563. Epub 2013 Dec 19.
Melhem A, Muhanna N, Bishara A, Alvarez CE, Ilan Y, Bishara T, Horani A, Nassar M, Friedman SL, Safadi R. Anti-fibrotic activity of NK cells in experimental liver injury through killing of activated HSC. J Hepatol. 2006 Jul;45(1):60-71. doi: 10.1016/j.jhep.2005.12.025. Epub 2006 Feb 8.
Shin S, Kim YH, Cho YM, Park Y, Han S, Choi BH, Choi JY, Han DJ. Interpreting CD56+ and CD163+ infiltrates in early versus late renal transplant biopsies. Am J Nephrol. 2015;41(4-5):362-9. doi: 10.1159/000430473. Epub 2015 Jun 18.
Victorino F, Sojka DK, Brodsky KS, McNamee EN, Masterson JC, Homann D, Yokoyama WM, Eltzschig HK, Clambey ET. Tissue-Resident NK Cells Mediate Ischemic Kidney Injury and Are Not Depleted by Anti-Asialo-GM1 Antibody. J Immunol. 2015 Nov 15;195(10):4973-85. doi: 10.4049/jimmunol.1500651. Epub 2015 Oct 9.
Brusilovsky M, Radinsky O, Cohen L, Yossef R, Shemesh A, Braiman A, Mandelboim O, Campbell KS, Porgador A. Regulation of natural cytotoxicity receptors by heparan sulfate proteoglycans in -cis: A lesson from NKp44. Eur J Immunol. 2015 Apr;45(4):1180-91. doi: 10.1002/eji.201445177. Epub 2015 Jan 21.
Breggia AC, Himmelfarb J. Primary mouse renal tubular epithelial cells have variable injury tolerance to ischemic and chemical mediators of oxidative stress. Oxid Med Cell Longev. 2008 Oct-Dec;1(1):33-8. doi: 10.4161/oxim.1.1.6491.
Jeong EM, Kim CW, Cho SY, Jang GY, Shin DM, Jeon JH, Kim IG. Degradation of transglutaminase 2 by calcium-mediated ubiquitination responding to high oxidative stress. FEBS Lett. 2009 Feb 18;583(4):648-54. doi: 10.1016/j.febslet.2009.01.032. Epub 2009 Feb 1.
Anglicheau D, Muthukumar T, Hummel A, Ding R, Sharma VK, Dadhania D, Seshan SV, Schwartz JE, Suthanthiran M. Discovery and validation of a molecular signature for the noninvasive diagnosis of human renal allograft fibrosis. Transplantation. 2012 Jun 15;93(11):1136-46. doi: 10.1097/TP.0b013e31824ef181.
Halloran PF, Famulski KS, Reeve J. Molecular assessment of disease states in kidney transplant biopsy samples. Nat Rev Nephrol. 2016 Sep;12(9):534-48. doi: 10.1038/nrneph.2016.85. Epub 2016 Jun 27.
Other Identifiers
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NRF-2016M3A9E8941330
Identifier Type: -
Identifier Source: org_study_id
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