TruGraf® Long-term Clinical Outcomes Study

NCT04491552 | Unknown FDA Device

• 1 other identifier: TGRP06
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 36

Brief Summary

This is a prospective, multi-center, observational study. Subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at study enrollment and thereafter every 3 months. In addition subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at any time there is a clinical suspicion of acute rejection. Data collection for the primary objective extends over a 2-year period.

Conditions

Kidney Transplant Rejection

Keywords

Biomarkers; Subclinical Rejection

Outcome Measures

Primary Outcomes (1)

• occurrence of either biopsy proven acute rejection (BPAR) on a for cause biopsy or graft loss, or a decrease from baseline in eGFR > 10 mL/min.

  Baseline to month 24

Secondary Outcomes (13)

• First occurrence of biopsy proven acute rejection (on a for cause biopsy)

  Baseline to month 24

• First occurrence of clinically treated acute rejection

  Baseline to month 24

• Proteinuria

  Baseline to month 24

• TruGraf results

  Baseline to month 24

• TRAC results

  Baseline to month 24

Study Arms (1)

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.

Diagnostic Test: Patients monitored with TruGraf and TRAC testing

Interventions

Patients monitored with TruGraf and TRAC testing DIAGNOSTIC_TEST

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.

Patients monitored with TruGraf and TRAC testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is an observational study in adult (age ≥ 18 years), kidney transplant patients who are at least one year from the time of transplant. Approximately 2000 subjects will be enrolled.

You may qualify if:

• Written informed consent and HIPAA authorization;
• 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

You may not qualify if:

• Recipient of a combined organ transplant with an extra-renal organ and/or islet cell transplant;
• 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.

Sponsors & Collaborators

• Transplant Genomics, Inc.: lead

Study Sites (36)

Banner University Medical Center Tucson

Tucson, Arizona, 85724, United States

RECRUITING

Fresno Nephrology Medical Group

Fresno, California, 93720, United States

RECRUITING

Scripps Memorial Hospital La Jolla

La Jolla, California, 92037, United States

RECRUITING

Keck Hospital of USC

Los Angeles, California, 90033, United States

RECRUITING

House of Transplant and Cancer- Riverside Community Hospital

Riverside, California, 92501, United States

RECRUITING

University of California Davis

Sacramento, California, 95817, United States

RECRUITING

California Pacific Medical Center

San Francisco, California, 94109, United States

RECRUITING

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60208, United States

RECRUITING

University of Illinois-Chicago Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Tulane University Hospital and Clinic

New Orleans, Louisiana, 70112, United States

RECRUITING

Willis-Knighton Medical Center

Shreveport, Louisiana, 71103, United States

RECRUITING

Universtiy of Maryland Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Renal and Transplant Associates of New England

Springfield, Massachusetts, 01107, United States

RECRUITING

Primary Coordinator Coordinator

St Louis, Missouri, 63110, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87106, United States

RECRUITING

Erie County Medical Center

Buffalo, New York, 14215, United States

RECRUITING

University of Rochester Medical Center

Rochester, New York, 14618, United States

RECRUITING

UR Medicine Strong Memorial Hospital

Rochester, New York, 14642, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Vidant Medical Center

Greenville, North Carolina, 27834, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Clinical Research Strategies

Houston, Texas, 77030, United States

RECRUITING

Utah Kidney Research Institute

Salt Lake City, Utah, 84115, United States

RECRUITING

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

RECRUITING

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

Primary Coordinator

Seattle, Washington, 98195, United States

RECRUITING

Related Publications (13)

• 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.

  PMID: 21883901 BACKGROUND

• 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.

  PMID: 26755262 BACKGROUND

• 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.

  PMID: 14961990 BACKGROUND

• 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.

  PMID: 9808101 BACKGROUND

• 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.

  PMID: 23865852 BACKGROUND

• 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.

  PMID: 25556173 BACKGROUND

• 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).

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 30979456 BACKGROUND

• 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.

  PMID: 21444804 BACKGROUND

• 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.

  PMID: 26460048 BACKGROUND

• 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.

  PMID: 26184824 BACKGROUND

• 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.

  PMID: 28771616 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

Study Officials

• Patty W. Thielke, PharmD

  Transplant Genomics, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isioma Agboli, MD

CONTACT

510-767-8609; isiomaagboli@eurofins-tgi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 29, 2020
• Study Start: September 9, 2020
• Primary Completion: September 1, 2023
• Study Completion: November 1, 2023
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (36)