<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/NCT03036748</url>
  </required_header>
  <id_info>
    <org_study_id>ENaC activation</org_study_id>
    <nct_id>NCT03036748</nct_id>
  </id_info>
  <brief_title>Increased Activity of ENaC in Proteinuric Kidney Transplant Recipients</brief_title>
  <official_title>Increased Activity of ENaC in Proteinuric Kidney Transplant Recipients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Region of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern Denmark</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to determine if amiloride, a diuretic drug, is capable of increasing&#xD;
      renal salt excretion, lowering blood pressure and inhibiting uPA in kidney transplant&#xD;
      recipients with proteinuria compared to normoalbuminuric transplant patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">September 1, 2021</completion_date>
  <primary_completion_date type="Actual">September 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Experimental: Kidney transplant recipients with ACR &gt; 300mg/g receiving standardized sodium diet (150 mmol NaCl/day) for 5 days and amiloride tablet 10 mg two times daily (morning and afternoon) on the last day.&#xD;
Interventions:◦Dietary Supplement: Standardized salt diet&#xD;
◦Drug: Amiloride&#xD;
•Experimental: Kidney transplant recipient with ACR&lt; 30mg/g (Control) receiving a standardized salt diet (150 mmol NaCl/day) for 5 days, then amiloride tablet 10 mg two times daily (morning and afternoon) for 1 day.&#xD;
Interventions:◦Dietary Supplement: Standardized salt diet&#xD;
◦Drug: Amiloride</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>open label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>24-hour urinary sodium excretion induced by amiloride</measure>
    <time_frame>Change from baseline urinary sodium (after 4 days of standadized sodium diet) excretion at 24 hours after amiloride administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Office or 24h blood pressure measurements</measure>
    <time_frame>Change from baseline office blood pressure at day 4 of salt diet and at 24 hours after amiloride administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Kidney Transplant; Complications</condition>
  <arm_group>
    <arm_group_label>TX control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Kidney transplant recipients with urinary albumin/creatinin-ratio &lt; 30mg/g</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TX Proteinuria</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Kidney transplant recipients with urinary albumin/creatinin-ratio &gt; 300mg/g</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Standardized sodium diet</intervention_name>
    <description>Dietary Supplement: Standardized salt diet 150 mmol NaCl per day given as three meals daily for 5 consecutive days.</description>
    <arm_group_label>TX Proteinuria</arm_group_label>
    <arm_group_label>TX control</arm_group_label>
    <other_name>Diet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tbl amiloride</intervention_name>
    <description>Drug: Amiloride Amiloride tablet 10 mg two times daily (morning and afternoon) for one day</description>
    <arm_group_label>TX Proteinuria</arm_group_label>
    <arm_group_label>TX control</arm_group_label>
    <other_name>Amiloride</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  One Group of kidney transplant recipients with ACR&lt; 30mg/g&#xD;
&#xD;
          -  One Group of kidney transplant recipients with ACR &gt;300mg/g&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment with amiloride, spironolactone, aldosterone- or analogs or tranexamsyre&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Clinically relevant organic or systemic disease including malignancy&#xD;
&#xD;
          -  eGFR or creatinin-clearance &lt; 30ml/min&#xD;
&#xD;
          -  hyperkalemia (s-potassium &gt; 5,0mmol/l)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gitte Rye Hinrichs, MD, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cardiovascular and Renal research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>December 23, 2022</last_update_submitted>
  <last_update_submitted_qc>December 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern Denmark</investigator_affiliation>
    <investigator_full_name>Gitte Rye Hinrichs</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amiloride</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/NCT03036748
org study id: ENaC activation
nct id: NCT03036748
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to determine if amiloride, a diuretic drug, is capable of increasing
      renal salt excretion, lowering blood pressure and inhibiting uPA in kidney transplant
      recipients with proteinuria compared to normoalbuminuric transplant patients.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Experimental: Kidney transplant recipients with ACR > 300mg/g receiving standardized sodium diet (150 mmol NaCl/day) for 5 days and amiloride tablet 10 mg two times daily (morning and afternoon) on the last day.
Interventions:◦Dietary Supplement: Standardized salt diet
◦Drug: Amiloride
•Experimental: Kidney transplant recipient with ACR< 30mg/g (Control) receiving a standardized salt diet (150 mmol NaCl/day) for 5 days, then amiloride tablet 10 mg two times daily (morning and afternoon) for 1 day.
Interventions:◦Dietary Supplement: Standardized salt diet
◦Drug: Amiloride
primary purpose: Basic Science
masking: None (Open Label)
masking description: open label
measure: 24-hour urinary sodium excretion induced by amiloride
time frame: Change from baseline urinary sodium (after 4 days of standadized sodium diet) excretion at 24 hours after amiloride administration
measure: Office or 24h blood pressure measurements
time frame: Change from baseline office blood pressure at day 4 of salt diet and at 24 hours after amiloride administration
arm group label: TX control
arm group type: Experimental
description: Kidney transplant recipients with urinary albumin/creatinin-ratio < 30mg/g
arm group label: TX Proteinuria
arm group type: Experimental
description: Kidney transplant recipients with urinary albumin/creatinin-ratio > 300mg/g
intervention type: Dietary Supplement
intervention name: Standardized sodium diet
description: Dietary Supplement: Standardized salt diet 150 mmol NaCl per day given as three meals daily for 5 consecutive days.
arm group label: TX Proteinuria
arm group label: TX control
other name: Diet
intervention type: Drug
intervention name: Tbl amiloride
description: Drug: Amiloride Amiloride tablet 10 mg two times daily (morning and afternoon) for one day
arm group label: TX Proteinuria
arm group label: TX control
other name: Amiloride
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Gitte Rye Hinrichs, MD, PHD
role: Principal Investigator
affiliation: Cardiovascular and Renal research
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Southern Denmark
investigator full name: Gitte Rye Hinrichs
investigator title: Doctor
mesh term: Amiloride