<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/NCT02230202</url>
  </required_header>
  <id_info>
    <org_study_id>14-1209</org_study_id>
    <secondary_id>UL1TR001082</secondary_id>
    <nct_id>NCT02230202</nct_id>
  </id_info>
  <brief_title>Endothelial Microparticles: A Novel Marker of Vascular Dysfunction</brief_title>
  <official_title>Endothelial Microparticles: A Novel Marker of Vascular Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary hypothesis of this proposal is that chronic kidney disease (CKD) and treatment&#xD;
      with calcineurin inhibitors (CNIs) are each associated with the release of endothelial&#xD;
      microparticles into the plasma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary hypothesis of this proposal is that chronic kidney disease (CKD) and treatment&#xD;
      with calcineurin inhibitors (CNIs) are each associated with the release of endothelial&#xD;
      microparticles into the plasma. These injury-associated microparticles have a different&#xD;
      molecular/protein composition than those released from endothelial cells in healthy patients,&#xD;
      and their abundance correlates with vascular injury. To test this hypothesis the&#xD;
      investigators propose a 3 arm case-controlled study including normal controls, individuals&#xD;
      with stage III and IV CKD not receiving CNI therapy, and individuals with stage III and IV&#xD;
      CKD post kidney transplantation receiving a CNI. The goal of this study is to measure the&#xD;
      amount of microparticles in patients with kidney disease who have had a kidney transplant.&#xD;
      Another goal of this study is to see if the measurements of microparticles are related to&#xD;
      poor function of the vessels (endothelial dysfunction).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Change in Vascular Function</measure>
    <time_frame>percent change from baseline over 2 minutes</time_frame>
    <description>This will be measured with flow-mediated dilation and evaluate percent change from baseline over minutes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Characterization of Microparticle source from blood analysis</measure>
    <time_frame>Single time point</time_frame>
    <description>A single blood draw to distinguish micro particle source characterization based upon protein, lipid and cholesterol composition.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>Healthy control</arm_group_label>
    <description>Healthy control that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage III or IV CKD patients</arm_group_label>
    <description>Stage III or IV CKD patients that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post-transplant patients</arm_group_label>
    <description>Stage III or IV CKD Post-transplant patients that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Flow-mediated dilation</intervention_name>
    <description>Flow-mediated dilation used to measure vascular function. The test is minimally invasive, with only a slight discomfort due to the inflation of the arm cuff.</description>
    <arm_group_label>Healthy control</arm_group_label>
    <arm_group_label>Post-transplant patients</arm_group_label>
    <arm_group_label>Stage III or IV CKD patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>single blood draw</intervention_name>
    <description>single blood draw of approximately 45 mL.</description>
    <arm_group_label>Healthy control</arm_group_label>
    <arm_group_label>Post-transplant patients</arm_group_label>
    <arm_group_label>Stage III or IV CKD patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      plasma and urine biospecimens to be retained.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        90 volunteers from the Anschutz Medical Campus&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For Healthy controls:&#xD;
&#xD;
          -  BMI less than 40 kg/m^2&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
        For Stage III or IV CKD patients:&#xD;
&#xD;
          -  BMI less than 40 kg/m^2&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
          -  An estimated Glomerular-Filtration Rate (GFR) of 20-60 mL/min/1.73m^2&#xD;
&#xD;
        For Post-kidney transplant and stage III or IV CKD patients:&#xD;
&#xD;
          -  BMI less than 40 kg/m^2&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
          -  An estimated Glomerular-Filtration Rate (GFR) of 20-60 mL/min/1.73m^2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        For Healthy controls:&#xD;
&#xD;
        -Women pregnant or breastfeeding&#xD;
&#xD;
        For Stage III or IV CKD patients:&#xD;
&#xD;
          -  Women pregnant or breastfeeding&#xD;
&#xD;
          -  Adults with a life expectancy of less than one year&#xD;
&#xD;
          -  A history of significant liver disease or congestive heart failure&#xD;
&#xD;
          -  Hospitalization within the last three months&#xD;
&#xD;
          -  Active infection on antibiotic therapy&#xD;
&#xD;
          -  Uncontrolled hypertension (&gt;140/90)&#xD;
&#xD;
          -  Immunosuppressive therapy within the last year&#xD;
&#xD;
        For Post-transplant stage III or IV CKD patients:&#xD;
&#xD;
          -  Women pregnant or breastfeeding&#xD;
&#xD;
          -  Adults with a life expectancy of less than one year&#xD;
&#xD;
          -  A history of significant liver disease or congestive heart failure&#xD;
&#xD;
          -  Hospitalization within the last three months&#xD;
&#xD;
          -  Active infection on antibiotic therapy&#xD;
&#xD;
          -  Uncontrolled hypertension (&gt;140/90)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joshua M Thurman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Anschutz Medical Campus; CTRC</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado School of Medicine</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>February 26, 2018</last_update_submitted>
  <last_update_submitted_qc>February 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <!-- 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/NCT02230202
org study id: 14-1209
secondary id: UL1TR001082
nct id: NCT02230202
lead sponsor: 
has dmc: No
The primary hypothesis of this proposal is that chronic kidney disease (CKD) and treatment
      with calcineurin inhibitors (CNIs) are each associated with the release of endothelial
      microparticles into the plasma.
The primary hypothesis of this proposal is that chronic kidney disease (CKD) and treatment
      with calcineurin inhibitors (CNIs) are each associated with the release of endothelial
      microparticles into the plasma. These injury-associated microparticles have a different
      molecular/protein composition than those released from endothelial cells in healthy patients,
      and their abundance correlates with vascular injury. To test this hypothesis the
      investigators propose a 3 arm case-controlled study including normal controls, individuals
      with stage III and IV CKD not receiving CNI therapy, and individuals with stage III and IV
      CKD post kidney transplantation receiving a CNI. The goal of this study is to measure the
      amount of microparticles in patients with kidney disease who have had a kidney transplant.
      Another goal of this study is to see if the measurements of microparticles are related to
      poor function of the vessels (endothelial dysfunction).
observational model: Case-Control
time perspective: Cross-Sectional
measure: Change in Vascular Function
time frame: percent change from baseline over 2 minutes
description: This will be measured with flow-mediated dilation and evaluate percent change from baseline over minutes.
measure: Characterization of Microparticle source from blood analysis
time frame: Single time point
description: A single blood draw to distinguish micro particle source characterization based upon protein, lipid and cholesterol composition.
arm group label: Healthy control
description: Healthy control that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD).
arm group label: Stage III or IV CKD patients
description: Stage III or IV CKD patients that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD).
arm group label: Post-transplant patients
description: Stage III or IV CKD Post-transplant patients that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD).
intervention type: Other
intervention name: Flow-mediated dilation
description: Flow-mediated dilation used to measure vascular function. The test is minimally invasive, with only a slight discomfort due to the inflation of the arm cuff.
arm group label: Healthy control
arm group label: Post-transplant patients
arm group label: Stage III or IV CKD patients
intervention type: Other
intervention name: single blood draw
description: single blood draw of approximately 45 mL.
arm group label: Healthy control
arm group label: Post-transplant patients
arm group label: Stage III or IV CKD patients
plasma and urine biospecimens to be retained.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joshua M Thurman, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic