<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04491552</url>
  </required_header>
  <id_info>
    <org_study_id>TGRP06</org_study_id>
    <nct_id>NCT04491552</nct_id>
  </id_info>
  <brief_title>TruGraf® Long-term Clinical Outcomes Study</brief_title>
  <official_title>TruGraf® Long-term Clinical Outcomes Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Transplant Genomics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Transplant Genomics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, multi-center, observational study. Subjects will have OmniGraf™&#xD;
      (TruGraf® and TRAC™) testing at study enrollment and thereafter every 3 months. In addition&#xD;
      subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at any time there is a clinical&#xD;
      suspicion of acute rejection. Data collection for the primary objective extends over a 2-year&#xD;
      period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several studies have validated TruGraf® in stable renal transplant patients to rule out&#xD;
      subclinical acute rejection. These studies generally evaluated the diagnostic value of&#xD;
      TruGraf® at single timepoints. Thus the value of serial monitoring and changes over time has&#xD;
      not been previously investigated. In addition, no study has assessed TruGraf® and TRAC™in a&#xD;
      serial and longitudinal fashion.&#xD;
&#xD;
      Therefore the aim of this study is to evaluate the impact of serial monitoring renal&#xD;
      transplant patients with both TruGraf® and TRAC™ on long term outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 9, 2020</start_date>
  <completion_date type="Anticipated">November 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>occurrence of either biopsy proven acute rejection (BPAR) on a for cause biopsy or graft loss, or a decrease from baseline in eGFR &gt; 10 mL/min.</measure>
    <time_frame>Baseline to month 24</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>First occurrence of biopsy proven acute rejection (on a for cause biopsy)</measure>
    <time_frame>Baseline to month 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>First occurrence of clinically treated acute rejection</measure>
    <time_frame>Baseline to month 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proteinuria</measure>
    <time_frame>Baseline to month 24</time_frame>
    <description>defined by a spot urine protein-creatinine ratio &gt; 0.5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TruGraf results</measure>
    <time_frame>Baseline to month 24</time_frame>
    <description>The proportion of TruGraf not-TX results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TRAC results</measure>
    <time_frame>Baseline to month 24</time_frame>
    <description>The proportion of TRAC results &gt; 0.69</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Utility of TruGraf and TRAC in clinical decision making</measure>
    <time_frame>Baseline to month 24</time_frame>
    <description>Percent of total number of TruGraf results that the PI identified as having clinical utility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects who develop de novo donor-specific HLA antibodies class I and class II (dnDSA)</measure>
    <time_frame>Baseline to month 24</time_frame>
    <description>Proportion of subjects who develop de novo donor-specific HLA antibodies class I and class II (dnDSA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with graft loss</measure>
    <time_frame>Baseline to month 24</time_frame>
    <description>defined as permanent return to dialysis, retransplantation or patient death at any time during the 2-year primary follow-up study period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Graft survival</measure>
    <time_frame>Baseline to month 24</time_frame>
    <description>calculated from the date of kidney transplantation until data of graft loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with death-censored graft loss</measure>
    <time_frame>Baseline to month 24</time_frame>
    <description>defined as permanent return to dialysis or retransplantation at any time during the 2-year primary follow-up study period. Patients who die with a functioning graft will be right censored</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent subject death period</measure>
    <time_frame>Baseline to month 24</time_frame>
    <description>Subject death from any cause at any time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject survival</measure>
    <time_frame>Baseline to month 24</time_frame>
    <description>calculated from date of kidney transplantation until date of patient death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated GFR</measure>
    <time_frame>Baseline to month 24</time_frame>
    <description>calculated using the MDRD 4-variable equation</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Kidney Transplant Rejection</condition>
  <arm_group>
    <arm_group_label>Patients monitored with TruGraf and TRAC testing</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Patients monitored with TruGraf and TRAC testing</intervention_name>
    <description>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.</description>
    <arm_group_label>Patients monitored with TruGraf and TRAC testing</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        This study is an observational study in adult (age ≥ 18 years), kidney transplant patients&#xD;
        who are at least one year from the time of transplant. Approximately 2000 subjects will be&#xD;
        enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent and HIPAA authorization;&#xD;
&#xD;
          -  At least 18 years of age;&#xD;
&#xD;
          -  Recipient of a primary or subsequent deceased-donor or living-donor kidney transplant;&#xD;
&#xD;
          -  At least 3-months post-transplant;&#xD;
&#xD;
          -  Stable serum creatinine (per Principal Investigator);&#xD;
&#xD;
          -  Treated with any immunosuppressive regimen, and;&#xD;
&#xD;
          -  Selected by provider to undergo OmniGraf™ (TruGraf® and TRAC™) testing as part of&#xD;
             post-transplant care; and&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recipient of a combined organ transplant with an extra-renal organ and/or islet cell&#xD;
             transplant;&#xD;
&#xD;
          -  Recipient of a previous non-renal solid organ and/or islet cell transplant;&#xD;
&#xD;
          -  Known to be pregnant;&#xD;
&#xD;
          -  Known to be infected with HIV;&#xD;
&#xD;
          -  Known to have Active BK nephropathy;&#xD;
&#xD;
          -  Known to have nephrotic proteinuria (Per Principal Investigator);&#xD;
&#xD;
          -  Participation in other biomarker studies testing clinical utility.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patty W. Thielke, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Transplant Genomics, Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Isioma Agboli, MD</last_name>
    <phone>510-767-8609</phone>
    <email>isiomaagboli@eurofins-tgi.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Banner University Medical Center Tucson</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>stephm1@arizona.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fresno Nephrology Medical Group</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>ngill@themedicalresearchgroup.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Scripps Memorial Hospital La Jolla</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>barrick.bethany@scrippshealth.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Keck Hospital of USC</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>esther.park@med.usc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>House of Transplant and Cancer- Riverside Community Hospital</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92501</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>payam.javaherizadeh@hcahealthcare.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of California Davis</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>khowes@ucdavis.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>California Pacific Medical Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>razavirf@sutterhealth.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>MedStar Georgetown University Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>ALYSSA.STUCKE@georgetown.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60208</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <email>a-daud@northwestern.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Illinois-Chicago Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>kbruno@uic.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>edelaney2@kumc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tulane University Hospital and Clinic</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>dbartho@tulane.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Willis-Knighton Medical Center</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>sstephens2@wkhs.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universtiy of Maryland Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>maheen.khan@som.umaryland.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>ADUROCHER2@mgh.harvard.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>smcderm2@bidmc.harvard.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Renal and Transplant Associates of New England</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>JWhitbeck@rtane.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Primary Coordinator Coordinator</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator Coordinator</last_name>
      <email>devinwall@wustl.edu</email>
    </contact>
    <contact_backup>
      <last_name>Primary Coordinator</last_name>
      <email>aomar@wustl.edu</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>katie.ostlund@unmc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of New Mexico Health Sciences Center</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>dlsedillo@salud.unm.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>OMOHAMME@montefiore.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Erie County Medical Center</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>msacilowsk@ecmc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14618</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <email>Allison_Stewart@URMC.Rochester.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>UR Medicine Strong Memorial Hospital</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>allison_stewart@urmc.rochester.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vidant Medical Center</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <email>apontet21@ecu.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>grimml@ccf.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>jarrod.goodarz@pennmedicine.upenn.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Temple University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>sally.quinn@tuhs.temple.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>saundert@musc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>Morgan.Marsh@UTSouthwestern.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Research Strategies</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>sonny@kidneydocs.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Utah Kidney Research Institute</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clinical Research Manager</last_name>
      <email>ukrinephrology@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Utah Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>Amber.lamph@hsc.utah.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Inova Fairfax Hospital</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <email>lori.schlegel@inova.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>joyce.ruddley@vcuhealth.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Primary Coordinator</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary Coordinator</last_name>
      <email>nidhim3@Nephrology.washington.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>21883901</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26755262</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>14961990</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>9808101</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23865852</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25556173</PMID>
  </reference>
  <reference>
    <citation>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).</citation>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>30979456</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21444804</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26460048</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26184824</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>28771616</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>November 10, 2022</last_update_submitted>
  <last_update_submitted_qc>November 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Biomarkers</keyword>
  <keyword>Subclinical Rejection</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04491552
org study id: TGRP06
nct id: NCT04491552
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
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.
Several studies have validated TruGraf® in stable renal transplant patients to rule out
      subclinical acute rejection. These studies generally evaluated the diagnostic value of
      TruGraf® at single timepoints. Thus the value of serial monitoring and changes over time has
      not been previously investigated. In addition, no study has assessed TruGraf® and TRAC™in a
      serial and longitudinal fashion.

      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.
observational model: Cohort
time perspective: Prospective
measure: 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.
time frame: Baseline to month 24
measure: First occurrence of biopsy proven acute rejection (on a for cause biopsy)
time frame: Baseline to month 24
measure: First occurrence of clinically treated acute rejection
time frame: Baseline to month 24
measure: Proteinuria
time frame: Baseline to month 24
description: defined by a spot urine protein-creatinine ratio > 0.5
measure: TruGraf results
time frame: Baseline to month 24
description: The proportion of TruGraf not-TX results
measure: TRAC results
time frame: Baseline to month 24
description: The proportion of TRAC results > 0.69
measure: Clinical Utility of TruGraf and TRAC in clinical decision making
time frame: Baseline to month 24
description: Percent of total number of TruGraf results that the PI identified as having clinical utility
measure: Proportion of subjects who develop de novo donor-specific HLA antibodies class I and class II (dnDSA)
time frame: Baseline to month 24
description: Proportion of subjects who develop de novo donor-specific HLA antibodies class I and class II (dnDSA)
measure: Proportion of subjects with graft loss
time frame: Baseline to month 24
description: defined as permanent return to dialysis, retransplantation or patient death at any time during the 2-year primary follow-up study period
measure: Graft survival
time frame: Baseline to month 24
description: calculated from the date of kidney transplantation until data of graft loss
measure: Proportion of subjects with death-censored graft loss
time frame: Baseline to month 24
description: defined as permanent return to dialysis or retransplantation at any time during the 2-year primary follow-up study period. Patients who die with a functioning graft will be right censored
measure: Percent subject death period
time frame: Baseline to month 24
description: Subject death from any cause at any time
measure: Subject survival
time frame: Baseline to month 24
description: calculated from date of kidney transplantation until date of patient death
measure: Estimated GFR
time frame: Baseline to month 24
description: calculated using the MDRD 4-variable equation
arm group label: Patients monitored with TruGraf and TRAC testing
description: 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.
intervention type: Diagnostic Test
intervention name: Patients monitored with TruGraf and TRAC testing
description: 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.
arm group label: Patients monitored with TruGraf and TRAC testing
whole blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Patty W. Thielke, PharmD
role: Principal Investigator
affiliation: Transplant Genomics, Inc.
last name: Isioma Agboli, MD
phone: 510-767-8609
email: isiomaagboli@eurofins-tgi.com
facility: 
status: Recruiting
contact: 
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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facility: 
status: Recruiting
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facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
contact: 
country: United States
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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).
citation: 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.
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
responsible party type: Sponsor
sharing ipd: No