<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/NCT04430426</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-300005327</org_study_id>
    <nct_id>NCT04430426</nct_id>
  </id_info>
  <brief_title>Heterozygous Individuals for AGXT and Kidney Stones</brief_title>
  <official_title>Heterozygous Individuals for AGXT and Kidney Stones</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>No</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>
      This study seeks to examine the effects of a heterozygous mutation of the AGXT gene in a&#xD;
      stone forming population on endogenous oxalate production. Participants will consume a&#xD;
      controlled low-oxalate diet and provide blood and urine samples to measure the amount of&#xD;
      oxalate in their bodies. Subjects will then be administered an intravenous (IV) load of&#xD;
      glycolate, providing additional blood and urine samples afterwards to measure any increase in&#xD;
      oxalate levels.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">January 1, 2024</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Urinary Oxalate Excretion</measure>
    <time_frame>Baseline through Day 6</time_frame>
    <description>Urinary oxalate excretion from urine samples will be measured as mg/day</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">4</enrollment>
  <condition>Kidney Stone</condition>
  <arm_group>
    <arm_group_label>Controlled Dietary Study</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will consume the controlled diet for five days and be administered an intravenous (IV) load of glycolate. Participants will provide urine and blood samples both before the glycolate load to establish baseline levels and after the glycolate load to measure oxalate levels afterwards.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Controlled Diet</intervention_name>
    <description>Participants will consume a controlled low oxalate diet for five days.</description>
    <arm_group_label>Controlled Dietary Study</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Glycolate Administration</intervention_name>
    <description>Participants will come to the UAB Clinical Research Unit (CRU) and be administered a glycolate load via intravenous (IV) catheter.</description>
    <arm_group_label>Controlled Dietary Study</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  at least 18 years of age&#xD;
&#xD;
          -  history of calcium oxalate stones&#xD;
&#xD;
          -  heterozygous mutation of the AGXT gene, as evidenced by results from the Invitae&#xD;
             Nephrolithiasis Panel&#xD;
&#xD;
          -  willingness to comply with a controlled diet for five days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant individuals&#xD;
&#xD;
          -  individuals who are currently breast feeding&#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>Kyle Wood, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Demond Wiley</last_name>
    <phone>205-934-3671</phone>
    <email>kidneystone@uabmc.edu</email>
  </overall_contact>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>February 1, 2023</last_update_submitted>
  <last_update_submitted_qc>February 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Kyle D. Wood</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>kidney stone</keyword>
  <keyword>oxalate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Calculi</mesh_term>
    <mesh_term>Nephrolithiasis</mesh_term>
    <mesh_term>Calculi</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glycolic acid</mesh_term>
  </intervention_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/NCT04430426
org study id: IRB-300005327
nct id: NCT04430426
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study seeks to examine the effects of a heterozygous mutation of the AGXT gene in a
      stone forming population on endogenous oxalate production. Participants will consume a
      controlled low-oxalate diet and provide blood and urine samples to measure the amount of
      oxalate in their bodies. Subjects will then be administered an intravenous (IV) load of
      glycolate, providing additional blood and urine samples afterwards to measure any increase in
      oxalate levels.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Urinary Oxalate Excretion
time frame: Baseline through Day 6
description: Urinary oxalate excretion from urine samples will be measured as mg/day
arm group label: Controlled Dietary Study
arm group type: Experimental
description: Participants will consume the controlled diet for five days and be administered an intravenous (IV) load of glycolate. Participants will provide urine and blood samples both before the glycolate load to establish baseline levels and after the glycolate load to measure oxalate levels afterwards.
intervention type: Other
intervention name: Controlled Diet
description: Participants will consume a controlled low oxalate diet for five days.
arm group label: Controlled Dietary Study
intervention type: Other
intervention name: Glycolate Administration
description: Participants will come to the UAB Clinical Research Unit (CRU) and be administered a glycolate load via intravenous (IV) catheter.
arm group label: Controlled Dietary Study
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kyle Wood, MD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
last name: Demond Wiley
phone: 205-934-3671
email: kidneystone@uabmc.edu
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Kyle D. Wood
investigator title: Principal Investigator
mesh term: Kidney Calculi
mesh term: Nephrolithiasis
mesh term: Calculi
mesh term: Glycolic acid