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
2000 participants
OBSERVATIONAL
2020-09-09
2023-11-30
Brief Summary
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Detailed Description
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Therefore the aim of this study is to evaluate the impact of serial monitoring renal transplant patients with both TruGraf® and TRAC™ on long term outcomes.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients monitored with TruGraf and TRAC testing
Subjects will have TruGraf and TRAC testing at study enrollment (Baseline) and thereafter every 3 months. In addition subjects will have TRAC testing at any time there is a suspicion of acute rejection.
Patients monitored with TruGraf and TRAC testing
This is an observational study there are no protocol mandated interventions. TruGraf and TRAC results will be utilized in conjunction with standard of care assessments to determine patient management.
Interventions
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Patients monitored with TruGraf and TRAC testing
This is an observational study there are no protocol mandated interventions. TruGraf and TRAC results will be utilized in conjunction with standard of care assessments to determine patient management.
Eligibility Criteria
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Inclusion Criteria
* At least 18 years of age;
* Recipient of a primary or subsequent deceased-donor or living-donor kidney transplant;
* At least 3-months post-transplant;
* Stable serum creatinine (per Principal Investigator);
* Treated with any immunosuppressive regimen, and;
* Selected by provider to undergo OmniGraf™ (TruGraf® and TRAC™) testing as part of post-transplant care; and
Exclusion Criteria
* Recipient of a previous non-renal solid organ and/or islet cell transplant;
* Known to be pregnant;
* Known to be infected with HIV;
* Known to have Active BK nephropathy;
* Known to have nephrotic proteinuria (Per Principal Investigator);
* Participation in other biomarker studies testing clinical utility.
18 Years
ALL
No
Sponsors
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Transplant Genomics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Patty W. Thielke, PharmD
Role: PRINCIPAL_INVESTIGATOR
Transplant Genomics, Inc.
Locations
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Banner University Medical Center Tucson
Tucson, Arizona, United States
Fresno Nephrology Medical Group
Fresno, California, United States
Scripps Memorial Hospital La Jolla
La Jolla, California, United States
Keck Hospital of USC
Los Angeles, California, United States
House of Transplant and Cancer- Riverside Community Hospital
Riverside, California, United States
University of California Davis
Sacramento, California, United States
California Pacific Medical Center
San Francisco, California, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Northwestern University
Chicago, Illinois, United States
University of Illinois-Chicago Medical Center
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Tulane University Hospital and Clinic
New Orleans, Louisiana, United States
Willis-Knighton Medical Center
Shreveport, Louisiana, United States
Universtiy of Maryland Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Renal and Transplant Associates of New England
Springfield, Massachusetts, United States
Primary Coordinator Coordinator
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
Erie County Medical Center
Buffalo, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
UR Medicine Strong Memorial Hospital
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Vidant Medical Center
Greenville, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Clinical Research Strategies
Houston, Texas, United States
Utah Kidney Research Institute
Salt Lake City, Utah, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Primary Coordinator
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Sharon E, Shi H, Kharbanda S, Koh W, Martin LR, Khush KK, Valantine H, Pritchard JK, De Vlaminck I. Quantification of transplant-derived circulating cell-free DNA in absence of a donor genotype. PLoS Comput Biol. 2017 Aug 3;13(8):e1005629. doi: 10.1371/journal.pcbi.1005629. eCollection 2017 Aug.
Marsh CL, Kurian SM, Rice JC, Whisenant TC, David J, Rose S, Schieve C, Lee D, Case J, Barrick B, Peddi VR, Mannon RB, Knight R, Maluf D, Mandelbrot D, Patel A, Friedewald JJ, Abecassis MM, First MR. Application of TruGraf v1: A Novel Molecular Biomarker for Managing Kidney Transplant Recipients With Stable Renal Function. Transplant Proc. 2019 Apr;51(3):722-728. doi: 10.1016/j.transproceed.2019.01.054. Epub 2019 Jan 26.
Snyder TM, Khush KK, Valantine HA, Quake SR. Universal noninvasive detection of solid organ transplant rejection. Proc Natl Acad Sci U S A. 2011 Apr 12;108(15):6229-34. doi: 10.1073/pnas.1013924108. Epub 2011 Mar 28.
De Vlaminck I, Martin L, Kertesz M, Patel K, Kowarsky M, Strehl C, Cohen G, Luikart H, Neff NF, Okamoto J, Nicolls MR, Cornfield D, Weill D, Valantine H, Khush KK, Quake SR. Noninvasive monitoring of infection and rejection after lung transplantation. Proc Natl Acad Sci U S A. 2015 Oct 27;112(43):13336-41. doi: 10.1073/pnas.1517494112. Epub 2015 Oct 12.
Gielis EM, Ledeganck KJ, De Winter BY, Del Favero J, Bosmans JL, Claas FH, Abramowicz D, Eikmans M. Cell-Free DNA: An Upcoming Biomarker in Transplantation. Am J Transplant. 2015 Oct;15(10):2541-51. doi: 10.1111/ajt.13387. Epub 2015 Jul 16.
Tonelli M, Wiebe N, Knoll G, Bello A, Browne S, Jadhav D, Klarenbach S, Gill J. Systematic review: kidney transplantation compared with dialysis in clinically relevant outcomes. Am J Transplant. 2011 Oct;11(10):2093-109. doi: 10.1111/j.1600-6143.2011.03686.x. Epub 2011 Aug 30.
Hart A, Smith JM, Skeans MA, Gustafson SK, Stewart DE, Cherikh WS, Wainright JL, Boyle G, Snyder JJ, Kasiske BL, Israni AK. Kidney. Am J Transplant. 2016 Jan;16 Suppl 2(Suppl 2):11-46. doi: 10.1111/ajt.13666.
Meier-Kriesche HU, Schold JD, Srinivas TR, Kaplan B. Lack of improvement in renal allograft survival despite a marked decrease in acute rejection rates over the most recent era. Am J Transplant. 2004 Mar;4(3):378-83. doi: 10.1111/j.1600-6143.2004.00332.x.
Rush D, Nickerson P, Gough J, McKenna R, Grimm P, Cheang M, Trpkov K, Solez K, Jeffery J. Beneficial effects of treatment of early subclinical rejection: a randomized study. J Am Soc Nephrol. 1998 Nov;9(11):2129-34. doi: 10.1681/ASN.V9112129.
El Ters M, Grande JP, Keddis MT, Rodrigo E, Chopra B, Dean PG, Stegall MD, Cosio FG. Kidney allograft survival after acute rejection, the value of follow-up biopsies. Am J Transplant. 2013 Sep;13(9):2334-41. doi: 10.1111/ajt.12370. Epub 2013 Jul 19.
Loupy A, Vernerey D, Tinel C, Aubert O, Duong van Huyen JP, Rabant M, Verine J, Nochy D, Empana JP, Martinez F, Glotz D, Jouven X, Legendre C, Lefaucheur C. Subclinical Rejection Phenotypes at 1 Year Post-Transplant and Outcome of Kidney Allografts. J Am Soc Nephrol. 2015 Jul;26(7):1721-31. doi: 10.1681/ASN.2014040399. Epub 2015 Jan 2.
First MR, Pierry, D, McNultuy, M et al. Analytical and clinical validation of a molecular diagnostic signature in kidney transplant recipients. J Transplant. Technol. Res. 2017; 7(3).
US Renal Data System. 2016 USRDS annual data report: Epidemiology of kidney disease in the United States. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2016.
Other Identifiers
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TGRP06
Identifier Type: -
Identifier Source: org_study_id
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