<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/NCT02216747</url>
  </required_header>
  <id_info>
    <org_study_id>RMC14 6413 CTIL</org_study_id>
    <nct_id>NCT02216747</nct_id>
  </id_info>
  <brief_title>Low Dose Steroids in the Treatment of Nephrotic Syndrome Relapse</brief_title>
  <acronym>NS</acronym>
  <official_title>Treatment of Nephrotic Syndrome Relapse With Low Steroid Dose</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rabin Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rabin Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background- Idiopathic Nephrotic syndrome is the common glomerular disease in childhood.&#xD;
      conventional treatment is steroid treatment and nearly 90% response to this treatment well.&#xD;
&#xD;
      Response to this treatment is the most important prognostic factor and this patients has a&#xD;
      benign disease course.&#xD;
&#xD;
      60-70% among patients that response to steroid treatment,will suffer a relapse of NS.repeated&#xD;
      steroids courses can lead to serious adverse events in children such as low bone&#xD;
      density,weight gain ,growth slow down ,elevated blood pressure and eye pressure.there is side&#xD;
      effect corelation between steroid dose and treatment duration.&#xD;
&#xD;
      guidelines for steroid dose for NS relapse are not based on retrospective clinical research&#xD;
      but only on Nephrologists and experts opinion.&#xD;
&#xD;
      Rational- What would be the optimal low dose steroids and the shortest time of treatment in&#xD;
      Nephrotic syndrome relapse?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Idiopathic nephrotic syndrome in children is the most common chronic glomerular disease. The&#xD;
      first line of therapy is prednisone and about 90% of the patients will&#xD;
&#xD;
      response to this treatment. The course of the disease is characterized of&#xD;
&#xD;
      recurrent relapses and repeated prednisone therapy. While prednisone doses and&#xD;
&#xD;
      therapy duration in the disease diagnosis has been based on multiple prospective&#xD;
&#xD;
      studies, the dose and therapy duration in the relapses was never challenged in a&#xD;
&#xD;
      prospective control study.&#xD;
&#xD;
      To address this question we designed prospective 3 arm study to evaluate the&#xD;
&#xD;
      effective of exception steroid regiment to treat relapses versus lower doses.&#xD;
&#xD;
      The study population is children in the age 2-18 year old with steroid sensitive nephrotic&#xD;
      syndrome.&#xD;
&#xD;
      After relapse will be diagnosed based on physical exam and urine tests, the&#xD;
&#xD;
      patients will randomize to receive prednisone doses that are 60/m2 or 45/ m2 or 30/ m2.&#xD;
&#xD;
      A measurement of time to obtain remission, duration of remission est. will be collected.&#xD;
&#xD;
      We plan to recruit 100 children in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">October 2015</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Nephrotic Syndrome Remission</measure>
    <time_frame>3 days</time_frame>
    <description>Undetectable protein in urine for 3 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Remission duration</measure>
    <time_frame>Weeks</time_frame>
    <description>The number of weeks since the patient stopped steroids therapy and was in a complete remission.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Edema</measure>
    <time_frame>within 14 days</time_frame>
    <description>A sign of treatment resistance or no response.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Glomerular Disease</condition>
  <arm_group>
    <arm_group_label>prednisone 60 mg/meter square Body Surface Aera</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A - 60 mg Prednisone/meter square Boby Surface Area( 30 twice)/day until there are 3 days of undetected protein in urine and tapering down to 40 mg ,30 mg, 20 mg ,10 mg and 5 mg and end.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>prednisone 45 mg/meter square BSA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>B- 45 mg prednisone / day until there are 3 days of undetected protein in urine and then 30 mg / day for two weeks and to 30,20,10,5 mg until treatment is ended.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>prednisone 30 mg/meter squer BSA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>C- treatment of twice daily prednisone 30 mg per day until there are 3 days of undetectible protein in urine and then tapering down to 20 ,10 ,5 until treatment is ended.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>prednisone 60 mg/meter square Body Surface Area</intervention_name>
    <description>treatment with prednisone 60 mg /meter square Body Surface Area to compare to other arms</description>
    <arm_group_label>prednisone 60 mg/meter square Body Surface Aera</arm_group_label>
    <other_name>Danalon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>prednisone 45 mg</intervention_name>
    <description>treatment with 45 mg prednisone to compare with other arms</description>
    <arm_group_label>prednisone 45 mg/meter square BSA</arm_group_label>
    <other_name>Danalon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>prednisone 30 mg</intervention_name>
    <description>treatment with 30 mg prednisone to compare with other arms.</description>
    <arm_group_label>prednisone 30 mg/meter squer BSA</arm_group_label>
    <other_name>Danalon</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with Idiopathic nephrotic syndrome with a flair that needs steroids&#xD;
             treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Steroid resistance or treatment with Cyclosporin or Cellcept&#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>Amit Dagan, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>nephrology institute Shneider Children Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amit Dagan, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Schneider childrens Hospital Nephrology Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shneider children Hospital Nephrology Institute</name>
      <address>
        <city>Petach-Tikva</city>
        <country>Israel</country>
      </address>
    </facility>
    <investigator>
      <last_name>Amit Dagan, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>August 13, 2014</last_update_submitted>
  <last_update_submitted_qc>August 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rabin Medical Center</investigator_affiliation>
    <investigator_full_name>Amit Dagan</investigator_full_name>
    <investigator_title>DR. Amit Dagan</investigator_title>
  </responsible_party>
  <keyword>Idiopathic Nephrotic syndrome relapse</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>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisone</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/NCT02216747
org study id: RMC14 6413 CTIL
nct id: NCT02216747
lead sponsor: 
has dmc: Yes
Background- Idiopathic Nephrotic syndrome is the common glomerular disease in childhood.
      conventional treatment is steroid treatment and nearly 90% response to this treatment well.

      Response to this treatment is the most important prognostic factor and this patients has a
      benign disease course.

      60-70% among patients that response to steroid treatment,will suffer a relapse of NS.repeated
      steroids courses can lead to serious adverse events in children such as low bone
      density,weight gain ,growth slow down ,elevated blood pressure and eye pressure.there is side
      effect corelation between steroid dose and treatment duration.

      guidelines for steroid dose for NS relapse are not based on retrospective clinical research
      but only on Nephrologists and experts opinion.

      Rational- What would be the optimal low dose steroids and the shortest time of treatment in
      Nephrotic syndrome relapse?
Idiopathic nephrotic syndrome in children is the most common chronic glomerular disease. The
      first line of therapy is prednisone and about 90% of the patients will

      response to this treatment. The course of the disease is characterized of

      recurrent relapses and repeated prednisone therapy. While prednisone doses and

      therapy duration in the disease diagnosis has been based on multiple prospective

      studies, the dose and therapy duration in the relapses was never challenged in a

      prospective control study.

      To address this question we designed prospective 3 arm study to evaluate the

      effective of exception steroid regiment to treat relapses versus lower doses.

      The study population is children in the age 2-18 year old with steroid sensitive nephrotic
      syndrome.

      After relapse will be diagnosed based on physical exam and urine tests, the

      patients will randomize to receive prednisone doses that are 60/m2 or 45/ m2 or 30/ m2.

      A measurement of time to obtain remission, duration of remission est. will be collected.

      We plan to recruit 100 children in this study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Nephrotic Syndrome Remission
time frame: 3 days
description: Undetectable protein in urine for 3 days
measure: Remission duration
time frame: Weeks
description: The number of weeks since the patient stopped steroids therapy and was in a complete remission.
measure: Edema
time frame: within 14 days
description: A sign of treatment resistance or no response.
arm group label: prednisone 60 mg/meter square Body Surface Aera
arm group type: Active Comparator
description: A - 60 mg Prednisone/meter square Boby Surface Area( 30 twice)/day until there are 3 days of undetected protein in urine and tapering down to 40 mg ,30 mg, 20 mg ,10 mg and 5 mg and end.
arm group label: prednisone 45 mg/meter square BSA
arm group type: Active Comparator
description: B- 45 mg prednisone / day until there are 3 days of undetected protein in urine and then 30 mg / day for two weeks and to 30,20,10,5 mg until treatment is ended.
arm group label: prednisone 30 mg/meter squer BSA
arm group type: Active Comparator
description: C- treatment of twice daily prednisone 30 mg per day until there are 3 days of undetectible protein in urine and then tapering down to 20 ,10 ,5 until treatment is ended.
intervention type: Drug
intervention name: prednisone 60 mg/meter square Body Surface Area
description: treatment with prednisone 60 mg /meter square Body Surface Area to compare to other arms
arm group label: prednisone 60 mg/meter square Body Surface Aera
other name: Danalon
intervention type: Drug
intervention name: prednisone 45 mg
description: treatment with 45 mg prednisone to compare with other arms
arm group label: prednisone 45 mg/meter square BSA
other name: Danalon
intervention type: Drug
intervention name: prednisone 30 mg
description: treatment with 30 mg prednisone to compare with other arms.
arm group label: prednisone 30 mg/meter squer BSA
other name: Danalon
criteria: 
gender: All
minimum age: 1 Year
maximum age: 18 Years
healthy volunteers: No
last name: Amit Dagan, Doctor
role: Principal Investigator
affiliation: nephrology institute Shneider Children Hospital
last name: Amit Dagan, Doctor
role: Principal Investigator
affiliation: Schneider childrens Hospital Nephrology Institute
facility: 
investigator: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Rabin Medical Center
investigator full name: Amit Dagan
investigator title: DR. Amit Dagan
mesh term: Nephrotic Syndrome
mesh term: Nephrosis
mesh term: Recurrence
mesh term: Prednisone