<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/NCT01705132</url>
  </required_header>
  <id_info>
    <org_study_id>205M13905</org_study_id>
    <nct_id>NCT01705132</nct_id>
  </id_info>
  <brief_title>Urinary Biomarkers of the Progression of Alport Kidney Disease</brief_title>
  <official_title>Urinary Biomarkers of the Progression of Alport Kidney Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novartis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine if there are certain laboratory tests that can be&#xD;
      performed to detect substances or features in a child's urine that can be used to measure the&#xD;
      progress of Alport kidney disease and the effects of treatment. These tests and their results&#xD;
      could be of use to measure responses to new treatments in future clinical trials.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective cross-sectional, observational, single-center study of affected Alport&#xD;
      patients who have not progressed to advanced chronic renal insufficiency (CKD Stages 4 or 5),&#xD;
      and who do not have nephrotic range proteinuria (urine protein-to-creatinine ratio &gt; 3).&#xD;
      There will be no required study site visits. Instead, encounters will occur via telephone&#xD;
      with subjects when they are at home. This study consists of a single, first morning voided&#xD;
      urine collection for subjects who meet eligibility criteria. Eligibility criteria and&#xD;
      informed consent can be obtained via telephone in order to be as non-intrusive to the subject&#xD;
      as possible.&#xD;
&#xD;
      Alport subjects will be recruited via the Alport Syndrome Treatments and Outcome Registry&#xD;
      (ASTOR, University of Minnesota). ASTOR is the largest Alport Syndrome registry in the USA,&#xD;
      comprised of approximately 500 people affected by Alport Syndrome. Subjects who meet&#xD;
      eligibility criteria will be asked to provide clinical and demographic information and a&#xD;
      single urine sample. A portion of the de-identified sample will be sent to Covance&#xD;
      Laboratories for processing for Novartis and the remainder will be processed, stored and&#xD;
      analyzed at the University of Minnesota. Subjects who provide consent will be given a kit and&#xD;
      instructions for collecting the urine sample. Kits will then be returned via overnight&#xD;
      courier to the study site. ASTOR study personnel will then communicate with subjects via the&#xD;
      telephone to confirm proper first-morning void collection technique, and to obtain clinical&#xD;
      historical information.&#xD;
&#xD;
      Approximately 80 Alport subjects will be enrolled in this study via ASTOR. Of the 80 Alport&#xD;
      subjects, approximately 25% (N = 20) should have no significant proteinuria (spot urine&#xD;
      protein-to-creatinine ratio ≤ 0.2), and approximately 75% (N = 60) should have non-postural,&#xD;
      non-nephrotic proteinuria (defined as spot urine protein-to-creatinine ratio &gt; 0.2 and &lt; 3 on&#xD;
      at least 2 of the last 3 clinical assessments). Approximately 40 healthy volunteers will&#xD;
      provide urine samples elsewhere, outside the scope of this protocol. Healthy volunteer urine&#xD;
      samples need not be first-morning voided specimens, however each specimen will be screened&#xD;
      via dipstick for semi-quantitative protein analysis. Only samples with negative or trace&#xD;
      protein on dipstick will be included in the study.&#xD;
&#xD;
      Informed consent forms will be included in the kit sent to each eligible Alport subject.&#xD;
      Informed consent will take place via telephone, and preferably via video chat/Skype whenever&#xD;
      possible.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Family-Based</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Urine levels of biomarkers, corrected for urine creatinine, in Alport subjects stratified by magnitude of proteinura.</measure>
    <time_frame>This is a cross-sectional study. Subjects will submit a single urine sample (Day 1).</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Alport Syndrome</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Subjects submit first morning urine. Portion of urine retained for ASTOR repository.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will be comprised of male and female subjects ≥ 5 years of age, with&#xD;
        or without existing Alport genotyping, regardless of specific genotype, and who meet all&#xD;
        other eligibility criteria. Subjects with existing Alport genotyping are preferred. Alport&#xD;
        subjects will be enrolled via ASTOR, and healthy volunteers will be enrolled elsewhere,&#xD;
        outside the scope of this protocol. Approximately 80 Alport syndrome subjects will be&#xD;
        enrolled in this study. Of the 80 subjects, 75% (N = 60) should have non-postural,&#xD;
        non-nephrotic proteinuria (defined as spot urine protein-to-creatinine ratio &lt; 3 on at&#xD;
        least 2 of the last 3 clinical assessments).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects eligible for inclusion in this study have to fulfill all of the following&#xD;
        criteria:&#xD;
&#xD;
          1. Able to understand and comply with the requirements of the study and able to provide&#xD;
             written informed consent.&#xD;
&#xD;
          2. Male and female subjects ≥ 5 years of age.&#xD;
&#xD;
          3. Physically able to provide a single first-morning urine sample of at least 30 mL (one&#xD;
             ounce).&#xD;
&#xD;
          4. Alport syndrome diagnosis: Clinical and/or histopathologic and/or genetic diagnosis of&#xD;
             Alport Syndrome, as per the subject's physician and/or genotyping.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects fulfilling any of the following criteria are not eligible for inclusion in this&#xD;
        study:&#xD;
&#xD;
          1. Use of investigational drugs at the time of enrollment, or within 30 days or 5&#xD;
             half-lives of enrollment, whichever is longer; or longer if required by local&#xD;
             regulations, and for any other limitation of participation in an investigational trial&#xD;
             based on local regulations.&#xD;
&#xD;
          2. Chronic kidney disease, defined as a known diagnosis of CKD, and/or receiving chronic&#xD;
             phosphate-lowering therapy or erythropoietin therapy.&#xD;
&#xD;
          3. Ongoing chronic hemodialysis therapy and/or renal transplant recipient.&#xD;
&#xD;
          4. Nephrotic-range proteinuria: spot urine protein-to-creatinine ratio ≥ 3 on at least 2&#xD;
             of the last 3 clinical assessments.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clifford E Kashtan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.alportregistry.org</url>
    <description>ASTOR website</description>
  </link>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>July 26, 2013</last_update_submitted>
  <last_update_submitted_qc>July 26, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 30, 2013</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>Nephritis, Hereditary</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/NCT01705132
org study id: 205M13905
nct id: NCT01705132
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the study is to determine if there are certain laboratory tests that can be
      performed to detect substances or features in a child's urine that can be used to measure the
      progress of Alport kidney disease and the effects of treatment. These tests and their results
      could be of use to measure responses to new treatments in future clinical trials.
This is a prospective cross-sectional, observational, single-center study of affected Alport
      patients who have not progressed to advanced chronic renal insufficiency (CKD Stages 4 or 5),
      and who do not have nephrotic range proteinuria (urine protein-to-creatinine ratio > 3).
      There will be no required study site visits. Instead, encounters will occur via telephone
      with subjects when they are at home. This study consists of a single, first morning voided
      urine collection for subjects who meet eligibility criteria. Eligibility criteria and
      informed consent can be obtained via telephone in order to be as non-intrusive to the subject
      as possible.

      Alport subjects will be recruited via the Alport Syndrome Treatments and Outcome Registry
      (ASTOR, University of Minnesota). ASTOR is the largest Alport Syndrome registry in the USA,
      comprised of approximately 500 people affected by Alport Syndrome. Subjects who meet
      eligibility criteria will be asked to provide clinical and demographic information and a
      single urine sample. A portion of the de-identified sample will be sent to Covance
      Laboratories for processing for Novartis and the remainder will be processed, stored and
      analyzed at the University of Minnesota. Subjects who provide consent will be given a kit and
      instructions for collecting the urine sample. Kits will then be returned via overnight
      courier to the study site. ASTOR study personnel will then communicate with subjects via the
      telephone to confirm proper first-morning void collection technique, and to obtain clinical
      historical information.

      Approximately 80 Alport subjects will be enrolled in this study via ASTOR. Of the 80 Alport
      subjects, approximately 25% (N = 20) should have no significant proteinuria (spot urine
      protein-to-creatinine ratio ≤ 0.2), and approximately 75% (N = 60) should have non-postural,
      non-nephrotic proteinuria (defined as spot urine protein-to-creatinine ratio > 0.2 and < 3 on
      at least 2 of the last 3 clinical assessments). Approximately 40 healthy volunteers will
      provide urine samples elsewhere, outside the scope of this protocol. Healthy volunteer urine
      samples need not be first-morning voided specimens, however each specimen will be screened
      via dipstick for semi-quantitative protein analysis. Only samples with negative or trace
      protein on dipstick will be included in the study.

      Informed consent forms will be included in the kit sent to each eligible Alport subject.
      Informed consent will take place via telephone, and preferably via video chat/Skype whenever
      possible.
observational model: Family-Based
time perspective: Prospective
measure: Urine levels of biomarkers, corrected for urine creatinine, in Alport subjects stratified by magnitude of proteinura.
time frame: This is a cross-sectional study. Subjects will submit a single urine sample (Day 1).
Subjects submit first morning urine. Portion of urine retained for ASTOR repository.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 65 Years
healthy volunteers: No
last name: Clifford E Kashtan, MD
role: Principal Investigator
affiliation: University of Minnesota
facility: 
country: United States
url: http://www.alportregistry.org
description: ASTOR website
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Nephritis, Hereditary