<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/NCT01716442</url>
  </required_header>
  <id_info>
    <org_study_id>RTX-2012</org_study_id>
    <nct_id>NCT01716442</nct_id>
  </id_info>
  <brief_title>Rituximab Trial for Pediatric Nephrotic Syndrome</brief_title>
  <acronym>RTX2012</acronym>
  <official_title>A Multi-center Randomized Controlled Trial of Rituximab for Refractory Nephrotic Syndrome in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Childrens Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Childrens Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anti-CD20 agent has been proposed as a rescue therapy for refractory nephrotic syndrome(NS)&#xD;
      on the basis of favorable clinical observations. Yet the long-term effect on maintaining&#xD;
      remission or the likelihood of becoming rituximab-dependent is unclear and the information on&#xD;
      the safety profile of rituximab is limited. This trial was designed to investigate the safety&#xD;
      and efficacy of Rituximab in children with refractory NS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">November 2013</completion_date>
  <primary_completion_date type="Anticipated">September 2013</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The remission rate of steroid-resistant nephrotic syndrome patients after rituximab treatment</measure>
    <time_frame>within 6 months from the initiation of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The rate of maintaining remission in steroid-dependent nephrotic syndrome patients</measure>
    <time_frame>within 6 months from the initiation of treatment versus placebo control</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">88</enrollment>
  <condition>Steroid Resistant Nephrotic Syndrome</condition>
  <condition>Steroid Dependent Nephrotic Syndrome</condition>
  <arm_group>
    <arm_group_label>steroid-resistant</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Steroid-resistant group: n=27 , enroll all for treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>steroid-dependent-rituximab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>steroid-responsive group: n=38</description>
  </arm_group>
  <arm_group>
    <arm_group_label>steroid-dependent-placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>steroid-responsive group: n=23</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>Per dose: Rituximab 375 mg/m2 (max.500mg/day). efficacy monitored by CD19 cell count. If CD19 cells are not depleted, second or third doses are given at 2-3 weeks interval.</description>
    <arm_group_label>steroid-dependent-rituximab</arm_group_label>
    <arm_group_label>steroid-resistant</arm_group_label>
    <other_name>Mabthera</other_name>
    <other_name>2005110300291 (rituximab)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>steroid-dependent-placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (A)steroid/calcineurin inhibitor resistant nephrotic syndrome&#xD;
&#xD;
          1. steroid resistance: no remission after 4 weeks of daily oral corticosteroid&#xD;
             (60mg/m2/day)&#xD;
&#xD;
          2. calcineurin inhibitor resistance: no remission after 3 months of therapeutic dose&#xD;
             administration of cyclosporine and/or tacrolimus&#xD;
&#xD;
          3. no remission defined by persistent proteinuria of nephrotic range for the last 3&#xD;
             months&#xD;
&#xD;
          4. post-transplant patients were included in the study&#xD;
&#xD;
        (B)steroid-dependent nephrotic syndrome&#xD;
&#xD;
          1. Steroid-dependent patients who had been on various known medications (such as&#xD;
             corticosteroids, cyclophosphamide, chlorambucil, calcineurin inhibitors, levamisole&#xD;
             ..) continuously for more than 2 years&#xD;
&#xD;
          2. definition of dependency: more than two consecutive relapse events in 2 weeks after&#xD;
             discontinuation of steroid or calcineurin inhibitor&#xD;
&#xD;
               -  no improvement in relapsing frequency with calcineurin inhibitor use&#xD;
&#xD;
               -  unable to continue with calcineurin inhibitor due to side effects&#xD;
&#xD;
               -  unable to continue with calcineurin inhibitor due to prolonged use (over 2 years)&#xD;
&#xD;
               -  other conditions in which the clinician considers difficult to control disease&#xD;
                  with steroids or calcineurin inhibitors only.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous rituximab use&#xD;
&#xD;
          -  secondary nephrotic syndrome&#xD;
&#xD;
          -  estimated GFR &lt;60mL/min/1.73m2 or under 50% of age-matched standard GFR&#xD;
&#xD;
          -  chronic or acute active infection (e.g. hepatitis B,C, herpes, varicella zoster)&#xD;
&#xD;
          -  prior live vaccine inoculation within 1 month (from the study enrollment)&#xD;
&#xD;
          -  cardiovascular diseases, pulmonary or pleural diseases&#xD;
&#xD;
          -  uncontrolled hypertension&#xD;
&#xD;
          -  leukocytopenia (absolute neutrophil count &lt;1500/mm3) or thrombocytopenia (&lt;75000/mm3)&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hee Gyung Kang A. Kang, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Children's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hee Gyung A. Kang, M.D., Ph.D.</last_name>
    <phone>+82-2072-0658</phone>
    <email>kanghg1@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National University Children's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-740</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>October 26, 2012</last_update_submitted>
  <last_update_submitted_qc>October 26, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 29, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Childrens Hospital</investigator_affiliation>
    <investigator_full_name>Hee Gyung Kang</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>rituximab</keyword>
  <keyword>nephrotic</keyword>
  <keyword>refractory</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nephrotic Syndrome</mesh_term>
    <mesh_term>Nephrosis</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rituximab</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/NCT01716442
org study id: RTX-2012
nct id: NCT01716442
lead sponsor: 
has dmc: No
Anti-CD20 agent has been proposed as a rescue therapy for refractory nephrotic syndrome(NS)
      on the basis of favorable clinical observations. Yet the long-term effect on maintaining
      remission or the likelihood of becoming rituximab-dependent is unclear and the information on
      the safety profile of rituximab is limited. This trial was designed to investigate the safety
      and efficacy of Rituximab in children with refractory NS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: The remission rate of steroid-resistant nephrotic syndrome patients after rituximab treatment
time frame: within 6 months from the initiation of treatment
measure: The rate of maintaining remission in steroid-dependent nephrotic syndrome patients
time frame: within 6 months from the initiation of treatment versus placebo control
arm group label: steroid-resistant
arm group type: Active Comparator
description: Steroid-resistant group: n=27 , enroll all for treatment
arm group label: steroid-dependent-rituximab
arm group type: Active Comparator
description: steroid-responsive group: n=38
arm group label: steroid-dependent-placebo
arm group type: Placebo Comparator
description: steroid-responsive group: n=23
intervention type: Drug
intervention name: Rituximab
description: Per dose: Rituximab 375 mg/m2 (max.500mg/day). efficacy monitored by CD19 cell count. If CD19 cells are not depleted, second or third doses are given at 2-3 weeks interval.
arm group label: steroid-dependent-rituximab
arm group label: steroid-resistant
other name: Mabthera
other name: 2005110300291 (rituximab)
intervention type: Drug
intervention name: Placebo
arm group label: steroid-dependent-placebo
criteria: 
gender: All
minimum age: 1 Year
maximum age: 18 Years
healthy volunteers: No
last name: Hee Gyung Kang A. Kang, M.D., Ph.D.
role: Principal Investigator
affiliation: Seoul National University Children's Hospital
last name: Hee Gyung A. Kang, M.D., Ph.D.
phone: +82-2072-0658
email: kanghg1@gmail.com
facility: 
status: Recruiting
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Childrens Hospital
investigator full name: Hee Gyung Kang
investigator title: Associate Professor
mesh term: Nephrotic Syndrome
mesh term: Nephrosis
mesh term: Syndrome
mesh term: Rituximab