<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/NCT02232763</url>
  </required_header>
  <id_info>
    <org_study_id>Losartan_tubularPU_2014</org_study_id>
    <nct_id>NCT02232763</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Losartan in Pediatric Chronic Kidney Disease With Tubular Proteinuria</brief_title>
  <official_title>A Prospective, Randomized, Cross-over Study Evaluating the Efficacy and Safety of Losartan in Pediatric Chronic Kidney Disease With Tubular Proteinuria</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;
      pediatric chronic kidney disease with tubular proteinuria.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children with tubular proteinuria (urine protein to creatinine ratio &gt; 0.3 mg/mg) were&#xD;
      randomly assigned in 1:1 ratio to losartan or placebo treatment for 12 weeks, then crossed&#xD;
      over to the opposite intervention for another three months after a washout period of 2 weeks.&#xD;
      The primary outcome is the change in urinary protein-creatinine ratio from baseline to the&#xD;
      end of 12 weeks. Efficacy of losartan in children with CKD with tubular proteinuria was also&#xD;
      investigated with additional retrospective review of medical record.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the change in urinary protein-creatinine ratio from baseline to the end of 12 weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in urinary protein excretion, determined as urinary Protein-creatinine ratio compared to baseline, after 12 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>12 weeks</time_frame>
    <description>Change in urinary albumin excretion, determined as urinary albumin-creatinine ratio compared to baseline, after 12 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>12 weeks</time_frame>
    <description>number of patients with wifh more than 50% decrease of urinary protein-creatinine ratio compared to baseline, after 12 weeks of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the change in urinary beta2-microglobulin-creatinine ratio from baseline to the end of study</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in urinary beta2-microglobulin--creatinine ratio compared to baseline, after 12 weeks of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the change in urinary NAG-creatinine ratio from baseline to the end of study</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in urinary NAG-creatinine ratio compared to baseline, after 12 weeks of treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Proteinuria</condition>
  <arm_group>
    <arm_group_label>Losartan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 weeks of losartan or placebo with crossover to the other</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 weeks of losartan or placebo with crossover to the other</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Losartan</intervention_name>
    <description>12 weeks of losartan or placebo with crossover to the other</description>
    <arm_group_label>Losartan</arm_group_label>
    <other_name>Cozaar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>12 weeks of losartan or placebo with crossover to the other</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 2years or older and younger than 18 years&#xD;
&#xD;
          -  estimated GFR ≥ 30mL/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;
          -  Renal hypoplasia/dysplasia, Reflux nephropathy, Polycystic kidney disease, Lowe&#xD;
             syndrome, Dent disease, Tubulointerstitial nephritis, Nephronophthisis/Medullary&#xD;
             cystic disease, Obstructive uropathy(including PUV, UPJ obstruction, UVJ obstruction)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hypertension&#xD;
&#xD;
          -  under dialysis or organ transplanted&#xD;
&#xD;
          -  bilateral renal artery stenosis or primary hyperaldosteronism&#xD;
&#xD;
          -  pregnant or nursing&#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>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>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Proteinuria</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/NCT02232763
org study id: Losartan_tubularPU_2014
nct id: NCT02232763
lead sponsor: 
collaborator: 
has dmc: No
The investigators hypothesize that using Losartan would help decrease proteinuria in
      pediatric chronic kidney disease with tubular proteinuria.
Children with tubular proteinuria (urine protein to creatinine ratio > 0.3 mg/mg) were
      randomly assigned in 1:1 ratio to losartan or placebo treatment for 12 weeks, then crossed
      over to the opposite intervention for another three months after a washout period of 2 weeks.
      The primary outcome is the change in urinary protein-creatinine ratio from baseline to the
      end of 12 weeks. Efficacy of losartan in children with CKD with tubular proteinuria was also
      investigated with additional retrospective review of medical record.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: the change in urinary protein-creatinine ratio from baseline to the end of 12 weeks
time frame: 12 weeks
description: Change in urinary protein excretion, determined as urinary Protein-creatinine ratio compared to baseline, after 12 weeks of treatment
measure: the change in urinary albumin-creatinine ratio from baseline to the end of study
time frame: 12 weeks
description: Change in urinary albumin excretion, determined as urinary albumin-creatinine ratio compared to baseline, after 12 weeks of treatment
measure: the proportion of patients wifh more than 50% decrease of urinary protein-creatinine ratio
time frame: 12 weeks
description: number of patients with wifh more than 50% decrease of urinary protein-creatinine ratio compared to baseline, after 12 weeks of treatment
measure: the change in urinary beta2-microglobulin-creatinine ratio from baseline to the end of study
time frame: 12 weeks
description: Change in urinary beta2-microglobulin--creatinine ratio compared to baseline, after 12 weeks of treatment
measure: the change in urinary NAG-creatinine ratio from baseline to the end of study
time frame: 12 weeks
description: Change in urinary NAG-creatinine ratio compared to baseline, after 12 weeks of treatment
arm group label: Losartan
arm group type: Experimental
description: 12 weeks of losartan or placebo with crossover to the other
arm group label: Placebo
arm group type: Experimental
description: 12 weeks of losartan or placebo with crossover to the other
intervention type: Drug
intervention name: Losartan
description: 12 weeks of losartan or placebo with crossover to the other
arm group label: Losartan
other name: Cozaar
intervention type: Drug
intervention name: Placebo
description: 12 weeks of losartan or placebo with crossover to the other
arm group label: Placebo
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: Renal Insufficiency, Chronic
mesh term: Proteinuria
mesh term: Losartan