<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/NCT01690039</url>
  </required_header>
  <id_info>
    <org_study_id>090/12</org_study_id>
    <nct_id>NCT01690039</nct_id>
  </id_info>
  <brief_title>Influence of Polymorphisms in the ATP6V1 Gene of the V-ATPase on the Development of Incomplete Distal Renal Tubular Acidosis</brief_title>
  <official_title>Comparison of Furosemide/Fludrocortisone With Ammonium Chloride Loading Test in the Diagnosis of Incomplete dRTA in Kidney Stone Formers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose&#xD;
&#xD;
        1. To compare the performance of the two currently employed urinary acidifications tests in&#xD;
           stone formers, the furosemide/fludrocortisone and ammonium chloride loading test.&#xD;
&#xD;
        2. To study the impact of polymorphisms in the genes ATP6V1B1, ATP6V0A4 and SLC4A1 on&#xD;
           urinary acidification in stone formers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">May 12, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Capability of urinary acidification</measure>
    <time_frame>Five to six hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Polymorphisms in the ATP6V1 gene</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">170</enrollment>
  <condition>Acidosis, Renal Tubular</condition>
  <condition>Nephrolithiasis</condition>
  <condition>Vacuolar Proton-Translocating ATPases</condition>
  <arm_group>
    <arm_group_label>All study participants</arm_group_label>
    <description>Furosemide-Fludrocortisone-Test and Ammonium chloride-Loading Test will be performed in renal stone patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Furosemide-Fludrocortisone-Test (test for urinary acidification)</intervention_name>
    <description>The presence of a lack of urinary acidification will be assessed by an appropriate test in all patients.</description>
    <arm_group_label>All study participants</arm_group_label>
    <other_name>Application of Furosemide (Lasix® ) and Fludrocortisone (Florinef®)</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients suffered from at least one kidney stone episode.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  One or more episodes of nephrolithiasis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absence of informed consent&#xD;
&#xD;
          -  All conditions affecting renal acidification&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Nursing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Fuster, Attending physician Nephrology</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Nephrology and Hypertension, Bern University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Nephrology and Hypertension, Bern University Hospital</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>http://www.nephrologie.insel.ch/</url>
    <description>Institution homepage</description>
  </link>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>October 8, 2018</last_update_submitted>
  <last_update_submitted_qc>October 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>renal tubular acidosis</keyword>
  <keyword>V-ATPase</keyword>
  <keyword>kidney stones</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nephrolithiasis</mesh_term>
    <mesh_term>Kidney Calculi</mesh_term>
    <mesh_term>Acidosis, Renal Tubular</mesh_term>
    <mesh_term>Acidosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fludrocortisone</mesh_term>
    <mesh_term>Furosemide</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/NCT01690039
org study id: 090/12
nct id: NCT01690039
lead sponsor: 
has dmc: No
Purpose

        1. To compare the performance of the two currently employed urinary acidifications tests in
           stone formers, the furosemide/fludrocortisone and ammonium chloride loading test.

        2. To study the impact of polymorphisms in the genes ATP6V1B1, ATP6V0A4 and SLC4A1 on
           urinary acidification in stone formers.
observational model: Case-Only
time perspective: Prospective
measure: Capability of urinary acidification
time frame: Five to six hours
measure: Polymorphisms in the ATP6V1 gene
time frame: 12 months
arm group label: All study participants
description: Furosemide-Fludrocortisone-Test and Ammonium chloride-Loading Test will be performed in renal stone patients.
intervention type: Drug
intervention name: Furosemide-Fludrocortisone-Test (test for urinary acidification)
description: The presence of a lack of urinary acidification will be assessed by an appropriate test in all patients.
arm group label: All study participants
other name: Application of Furosemide (Lasix® ) and Fludrocortisone (Florinef®)
Blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel Fuster, Attending physician Nephrology
role: Principal Investigator
affiliation: Department of Nephrology and Hypertension, Bern University Hospital
facility: 
country: Switzerland
url: http://www.nephrologie.insel.ch/
description: Institution homepage
responsible party type: Sponsor
mesh term: Nephrolithiasis
mesh term: Kidney Calculi
mesh term: Acidosis, Renal Tubular
mesh term: Acidosis
mesh term: Fludrocortisone
mesh term: Furosemide