<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/NCT02997150</url>
  </required_header>
  <id_info>
    <org_study_id>I15041 (NIL-2 pilote)</org_study_id>
    <nct_id>NCT02997150</nct_id>
  </id_info>
  <brief_title>Treatment of Steroid Dependent Idiopathic Nephrotic Syndrome in Children With Low Doses of Interleukin 2: a Pilot Study</brief_title>
  <acronym>NIL-2 pilote</acronym>
  <official_title>Treatment of Steroid Dependent Idiopathic Nephrotic Syndrome in Children With Low Doses of Interleukin 2: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Limoges</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Limoges</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      NIL-2 is a clinical trial designed to evaluate the efficacy and safety of low doses of&#xD;
      Interleukin2 in the treatment of recently diagnosed, steroid dependent idiopathic nephrotic&#xD;
      syndrome in children. Recent data suggest that Interleukin 2 could be an effective therapy&#xD;
      via an increased production of regulatory T cells.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will include 10 children (age: 3-15 years old). Patients will receive low doses of&#xD;
      Interleukin 2 (0.5 million UI/m²/ injection, subcutaneously).&#xD;
&#xD;
      The treatment will be initiated with an induction phase of one injection per day for 5&#xD;
      consecutive days, followed by a maintenance phase in which patients will receive one&#xD;
      injection every 14 days for 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    no treatment available&#xD;
  </why_stopped>
  <start_date type="Anticipated">February 2017</start_date>
  <completion_date type="Anticipated">October 2018</completion_date>
  <primary_completion_date type="Anticipated">August 2018</primary_completion_date>
  <phase>Phase 2</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>Number of success: absence of relapse of idiopathic nephrotic syndrome</measure>
    <time_frame>Day 184</time_frame>
    <description>Absence of relapse of idiopathic nephrotic syndrome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety of Interleukin-2</measure>
    <time_frame>Day 214</time_frame>
    <description>Study of adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Increase of regulatory T cells after 5 injections of Interleukin-2</measure>
    <time_frame>Day 8</time_frame>
    <description>increase of regulatory T cells (CD4+, CD25+, Foxp3 cells) from baseline to fifth injection, expressed as a percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Increase of regulatory T cells after 18 injections of Interleukin-2</measure>
    <time_frame>Day 184</time_frame>
    <description>increase of regulatory T cells (CD4+, CD25+, Foxp3 cells) from baseline to eighteenth injection, expressed as a percentage</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Nephrotic Syndrome Steroid-Dependent</condition>
  <condition>Interleukin 2</condition>
  <arm_group>
    <arm_group_label>IL-2 low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IL-2 Low dose</intervention_name>
    <description>Patients receive low doses of Interleukin 2: 0.5 million UI/m²/ injection subcutaneously.&#xD;
The treatment is initiated with an induction phase of one injection per day for 5 consecutive days, followed by a maintenance phase in which patients will receive one injection every 14 days for 6 months.&#xD;
At the same time, corticoid treatment will be tapered until its complete withdrawal no later than 3 months from the first injection</description>
    <arm_group_label>IL-2 low dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children between 3 and 15 years of age (included) with a steroid responsive idiopathic&#xD;
             nephrotic syndrome&#xD;
&#xD;
          -  Idiopathic nephrotic syndrome progressing for less than 1 year&#xD;
&#xD;
          -  Steroid dependent idiopathic nephrotic syndrome (at least 1 relapse when steroids are&#xD;
             tapered off or within 3 months after their withdrawal, and reliance on steroids &gt; 15&#xD;
             mg/m² every other day)&#xD;
&#xD;
          -  Steroid dose at inclusion between 15 and 60 mg/m²every other day&#xD;
&#xD;
          -  Patient with a stable dose of steroids within the 8 days before and after the first&#xD;
             injection of IL2&#xD;
&#xD;
          -  Patient in remission for more than 15 days&#xD;
&#xD;
          -  Patient affiliated to a French health insurance&#xD;
&#xD;
          -  Signed consent of parental authority&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypersensitivity to IL2 or to one of its excipients&#xD;
&#xD;
          -  Significant history or presence of cardiopathy&#xD;
&#xD;
          -  Signs of evolving infection requiring an antibiotic treatment&#xD;
&#xD;
          -  Respiratory distress, respiratory infection or chronic respiratory failure&#xD;
&#xD;
          -  Serious dysfunction of one of the vital organs&#xD;
&#xD;
          -  Leukocytes &lt; 4000/mm3 ; platelets &lt; 100 000/mm3; hematocrit &lt;30%&#xD;
&#xD;
          -  Anomaly of serum bilirubin and creatinin levels&#xD;
&#xD;
          -  History of organ allograft&#xD;
&#xD;
          -  Other pre-existing autoimmune disease&#xD;
&#xD;
          -  Male and female pubescent teenagers under the age of 15&#xD;
&#xD;
          -  Male and female teenagers whose puberty has begun for more than one year&#xD;
&#xD;
          -  Asthmatic patient&#xD;
&#xD;
          -  Pregnant or breastfeeding female patient&#xD;
&#xD;
          -  Participation in another therapeutic trial concurrently or 30 days prior to inclusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vincent Guigonis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Limoges</affiliation>
  </overall_official>
  <removed_countries>
    <country>France</country>
  </removed_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>May 29, 2018</last_update_submitted>
  <last_update_submitted_qc>May 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Idiopathic nephrotic syndrome-child-steroid dependant-IL2</keyword>
  <keyword>Safety</keyword>
  <keyword>Efficacy</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>
  <!-- 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/NCT02997150
org study id: I15041 (NIL-2 pilote)
nct id: NCT02997150
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
NIL-2 is a clinical trial designed to evaluate the efficacy and safety of low doses of
      Interleukin2 in the treatment of recently diagnosed, steroid dependent idiopathic nephrotic
      syndrome in children. Recent data suggest that Interleukin 2 could be an effective therapy
      via an increased production of regulatory T cells.
The study will include 10 children (age: 3-15 years old). Patients will receive low doses of
      Interleukin 2 (0.5 million UI/m²/ injection, subcutaneously).

      The treatment will be initiated with an induction phase of one injection per day for 5
      consecutive days, followed by a maintenance phase in which patients will receive one
      injection every 14 days for 6 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of success: absence of relapse of idiopathic nephrotic syndrome
time frame: Day 184
description: Absence of relapse of idiopathic nephrotic syndrome
measure: Safety of Interleukin-2
time frame: Day 214
description: Study of adverse events
measure: Increase of regulatory T cells after 5 injections of Interleukin-2
time frame: Day 8
description: increase of regulatory T cells (CD4+, CD25+, Foxp3 cells) from baseline to fifth injection, expressed as a percentage
measure: Increase of regulatory T cells after 18 injections of Interleukin-2
time frame: Day 184
description: increase of regulatory T cells (CD4+, CD25+, Foxp3 cells) from baseline to eighteenth injection, expressed as a percentage
arm group label: IL-2 low dose
arm group type: Experimental
intervention type: Drug
intervention name: IL-2 Low dose
description: Patients receive low doses of Interleukin 2: 0.5 million UI/m²/ injection subcutaneously.
The treatment is initiated with an induction phase of one injection per day for 5 consecutive days, followed by a maintenance phase in which patients will receive one injection every 14 days for 6 months.
At the same time, corticoid treatment will be tapered until its complete withdrawal no later than 3 months from the first injection
arm group label: IL-2 low dose
criteria: 
gender: All
minimum age: 3 Years
maximum age: 15 Years
healthy volunteers: No
last name: Vincent Guigonis, MD
role: Principal Investigator
affiliation: University Hospital, Limoges
country: France
responsible party type: Sponsor
mesh term: Nephrotic Syndrome
mesh term: Nephrosis
mesh term: Syndrome