<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/NCT04414111</url>
  </required_header>
  <id_info>
    <org_study_id>30530</org_study_id>
    <nct_id>NCT04414111</nct_id>
  </id_info>
  <brief_title>Highly Suppressive Treg in Delayed and Slow Graft Function After Kidney Transplantation</brief_title>
  <official_title>Highly Suppressive Treg as a Biomarker for Immunologically Relevant Delayed (DGF) and Slow (SGF) Graft Function After Kidney Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mid-America Transplant</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Louis University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Delayed/slow graft function is the most common complication after kidney transplantation with&#xD;
      an incidence over 20% and is the result of ischemia-reperfusion injury. The increased use of&#xD;
      marginal kidney grafts to palliate the organ shortage is leading to a continued rise in the&#xD;
      incidence of delayed/slow graft function. Delayed/slow graft function, however, is associated&#xD;
      with an increased risk of acute rejection and graft failure. There are currently no&#xD;
      clinically accepted biomarkers and no specific treatments for delayed/slow graft function.&#xD;
      Regulatory T cells are protective in ischemia-reperfusion injury and rejection by suppressing&#xD;
      pathologic immune responses. We hypothesize that the pre-transplant measurement of highly&#xD;
      suppressive regulatory T cell is an accurate biomarker for delayed/slow graft function and&#xD;
      its immunologic consequences. Ultimately, marginal kidney graft allocation could be directed&#xD;
      to regulatory T cell-robust recipients and regulatory T cell-directed therapies could&#xD;
      decrease marginal kidney graft discards without increasing delayed/slow graft function or&#xD;
      impacting outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 7, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 31, 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>Delayed graft function</measure>
    <time_frame>1 week</time_frame>
    <description>Delayed graft function defined as dialysis requirement within the first week after kidney transplant</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Slow graft function</measure>
    <time_frame>24 hours</time_frame>
    <description>Slow graft function defined as a serum creatinine drop of less than 20% in the first 24 hours after kidney transplant</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acute rejection</measure>
    <time_frame>1 year</time_frame>
    <description>Kidney allograft biopsy-proven acute rejection according to Banff criteria</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">140</enrollment>
  <condition>DGF</condition>
  <condition>Kidney Transplant; Complications</condition>
  <arm_group>
    <arm_group_label>Kidney transplant recipient</arm_group_label>
    <description>Kidney transplant recipient</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Highly suppressive Treg measurement</intervention_name>
    <description>Circulating highly suppressive Treg measurement</description>
    <arm_group_label>Kidney transplant recipient</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Kidney transplant recipients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Adult kidney transplant candidates immediately prior to their kidney transplant surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 18 years old&#xD;
&#xD;
          -  Active immunosuppressive drug use&#xD;
&#xD;
          -  Hepatitis C&#xD;
&#xD;
          -  HIV&#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>Henry Randall, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Louis University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Henry Randall, MD</last_name>
    <phone>314-257-8350</phone>
    <email>henry.randall@health.slu.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Loma Linda University Health Transplantation Institute</name>
      <address>
        <city>San Bernardino</city>
        <state>California</state>
        <zip>92408</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Minh-Tri JP Nguyen, MD, PhD</last_name>
      <phone>909-558-3668</phone>
      <phone_ext>33668</phone_ext>
      <email>minhtringuyen@llu.edu</email>
    </contact>
    <contact_backup>
      <last_name>Ryan Evans, CCRP</last_name>
      <phone>(909) 558-3870</phone>
      <email>rlevans@llu.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Minh-Tri JP Nguyen, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Louis University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>January 31, 2023</last_update_submitted>
  <last_update_submitted_qc>January 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Henry B. Randall, MD, MBA, FACS</investigator_full_name>
    <investigator_title>Professor of Surgery</investigator_title>
  </responsible_party>
  <keyword>DGF</keyword>
  <keyword>SGF</keyword>
  <keyword>Acute rejection</keyword>
  <keyword>Kidney transplantation</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04414111
org study id: 30530
nct id: NCT04414111
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Delayed/slow graft function is the most common complication after kidney transplantation with
      an incidence over 20% and is the result of ischemia-reperfusion injury. The increased use of
      marginal kidney grafts to palliate the organ shortage is leading to a continued rise in the
      incidence of delayed/slow graft function. Delayed/slow graft function, however, is associated
      with an increased risk of acute rejection and graft failure. There are currently no
      clinically accepted biomarkers and no specific treatments for delayed/slow graft function.
      Regulatory T cells are protective in ischemia-reperfusion injury and rejection by suppressing
      pathologic immune responses. We hypothesize that the pre-transplant measurement of highly
      suppressive regulatory T cell is an accurate biomarker for delayed/slow graft function and
      its immunologic consequences. Ultimately, marginal kidney graft allocation could be directed
      to regulatory T cell-robust recipients and regulatory T cell-directed therapies could
      decrease marginal kidney graft discards without increasing delayed/slow graft function or
      impacting outcomes.
observational model: Cohort
time perspective: Prospective
measure: Delayed graft function
time frame: 1 week
description: Delayed graft function defined as dialysis requirement within the first week after kidney transplant
measure: Slow graft function
time frame: 24 hours
description: Slow graft function defined as a serum creatinine drop of less than 20% in the first 24 hours after kidney transplant
measure: Acute rejection
time frame: 1 year
description: Kidney allograft biopsy-proven acute rejection according to Banff criteria
arm group label: Kidney transplant recipient
description: Kidney transplant recipient
intervention type: Diagnostic Test
intervention name: Highly suppressive Treg measurement
description: Circulating highly suppressive Treg measurement
arm group label: Kidney transplant recipient
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Henry Randall, MD
role: Principal Investigator
affiliation: St. Louis University
last name: Henry Randall, MD
phone: 314-257-8350
email: henry.randall@health.slu.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Active, not recruiting
country: United States
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Henry B. Randall, MD, MBA, FACS
investigator title: Professor of Surgery
sharing ipd: Undecided