<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/NCT02232776</url>
  </required_header>
  <id_info>
    <org_study_id>Losartan_IgA_2014</org_study_id>
    <nct_id>NCT02232776</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Losartan in Children With Ig A Nephropathy</brief_title>
  <official_title>A Prospective Study Evaluating the Efficacy and Safety of Losartan in Children With Immunoglobulin A Nephropathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Food and Drug Safety, Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesize that using Losartan would help decrease proteinuria in&#xD;
      controlling proteinuria in children with immunoglobulin A nephropathy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twenty nine patient with IgA nephropathy with proteinuria (urine protein to creatinine ratio&#xD;
      &gt; 0.3 mg/mg) were included in the study. All patients had received losartan treatment for 24&#xD;
      weeks. Changes in blood pressure, proteinuria, renal function, and biochemical parameters&#xD;
      were prospectively evaluated before and at 4 weeks and 24 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the change in urinary protein-creatinine ratio from baseline to the end of study</measure>
    <time_frame>24weeks</time_frame>
    <description>Change in urinary protein excretion, determined as urinary protein-creatinine ratio compared to baseline, after 24 weeks of treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the change in urinary albumin-creatinine ratio from baseline to the end of study</measure>
    <time_frame>24 weeks</time_frame>
    <description>Change in urinary albumin-creatinine ratio compared to baseline, after 24 weeks of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the proportion of patients wifh more than 50% decrease of urinary protein-creatinine ratio</measure>
    <time_frame>24 weeks</time_frame>
    <description>Number of patients with wifh more than 50% decrease of urinary protein-creatinine ratio compared to baseline, after 24 weeks of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the proportion of patients wifh urinary protein-creatinine ratio &lt; 0.2 at the end of study</measure>
    <time_frame>24 weeks</time_frame>
    <description>Number of patients wifh urinary protein-creatinine ratio &lt; 0.2 after 24 weeks of treatment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Glomerulonephritis, IGA</condition>
  <arm_group>
    <arm_group_label>Losartan treatement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients had received losartan treatment for 24 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Losartan</intervention_name>
    <description>Dose of Losartan : 0.7mg/kg once daily.</description>
    <arm_group_label>Losartan treatement</arm_group_label>
    <other_name>Cozaar</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 2years or older and younger than 18 years&#xD;
&#xD;
          -  Biopsy-proven Ig A Nephropathy&#xD;
&#xD;
          -  Estimated GFR ≥ 90mL/min/m^2&#xD;
&#xD;
          -  Mean urinary protein-creatinine ratio &gt; 0.3 g/g from three first-morning spot urine&#xD;
             collections&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hypertension&#xD;
&#xD;
          -  under dialysis or organ transplanted&#xD;
&#xD;
          -  bilateral renal artery stenosis&#xD;
&#xD;
          -  primary hyperaldosteronism&#xD;
&#xD;
          -  pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Months</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hee Gyung Kang, Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>Seoul National University Children's Hospital Departments of Pediatrics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Children's Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</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 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Losartan</keyword>
  <keyword>Ig A nephropathy</keyword>
  <keyword>children</keyword>
  <keyword>proteinuria</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Glomerulonephritis</mesh_term>
    <mesh_term>Glomerulonephritis, IGA</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Losartan</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/NCT02232776
org study id: Losartan_IgA_2014
nct id: NCT02232776
lead sponsor: 
collaborator: 
has dmc: No
The investigators hypothesize that using Losartan would help decrease proteinuria in
      controlling proteinuria in children with immunoglobulin A nephropathy.
Twenty nine patient with IgA nephropathy with proteinuria (urine protein to creatinine ratio
      > 0.3 mg/mg) were included in the study. All patients had received losartan treatment for 24
      weeks. Changes in blood pressure, proteinuria, renal function, and biochemical parameters
      were prospectively evaluated before and at 4 weeks and 24 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: the change in urinary protein-creatinine ratio from baseline to the end of study
time frame: 24weeks
description: Change in urinary protein excretion, determined as urinary protein-creatinine ratio compared to baseline, after 24 weeks of treatment.
measure: the change in urinary albumin-creatinine ratio from baseline to the end of study
time frame: 24 weeks
description: Change in urinary albumin-creatinine ratio compared to baseline, after 24 weeks of treatment.
measure: the proportion of patients wifh more than 50% decrease of urinary protein-creatinine ratio
time frame: 24 weeks
description: Number of patients with wifh more than 50% decrease of urinary protein-creatinine ratio compared to baseline, after 24 weeks of treatment.
measure: the proportion of patients wifh urinary protein-creatinine ratio < 0.2 at the end of study
time frame: 24 weeks
description: Number of patients wifh urinary protein-creatinine ratio < 0.2 after 24 weeks of treatment.
arm group label: Losartan treatement
arm group type: Experimental
description: All patients had received losartan treatment for 24 weeks.
intervention type: Drug
intervention name: Losartan
description: Dose of Losartan : 0.7mg/kg once daily.
arm group label: Losartan treatement
other name: Cozaar
criteria: 
gender: All
minimum age: 24 Months
maximum age: 18 Years
healthy volunteers: No
last name: Hee Gyung Kang, Ph.D
role: Study Chair
affiliation: Seoul National University Children's Hospital Departments of Pediatrics
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Glomerulonephritis
mesh term: Glomerulonephritis, IGA
mesh term: Losartan