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Treatment of Steroid Dependent Idiopathic Nephrotic Syndrome in Children With Low Doses of Interleukin 2: a Pilot Study (NIL-2 pilote)

Primary Purpose

Nephrotic Syndrome Steroid-Dependent, Interleukin 2

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
IL-2 Low dose
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrotic Syndrome Steroid-Dependent focused on measuring Idiopathic nephrotic syndrome-child-steroid dependant-IL2, Safety, Efficacy

Eligibility Criteria

3 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children between 3 and 15 years of age (included) with a steroid responsive idiopathic nephrotic syndrome
  • Idiopathic nephrotic syndrome progressing for less than 1 year
  • Steroid dependent idiopathic nephrotic syndrome (at least 1 relapse when steroids are tapered off or within 3 months after their withdrawal, and reliance on steroids > 15 mg/m² every other day)
  • Steroid dose at inclusion between 15 and 60 mg/m²every other day
  • Patient with a stable dose of steroids within the 8 days before and after the first injection of IL2
  • Patient in remission for more than 15 days
  • Patient affiliated to a French health insurance
  • Signed consent of parental authority

Exclusion Criteria:

  • Hypersensitivity to IL2 or to one of its excipients
  • Significant history or presence of cardiopathy
  • Signs of evolving infection requiring an antibiotic treatment
  • Respiratory distress, respiratory infection or chronic respiratory failure
  • Serious dysfunction of one of the vital organs
  • Leukocytes < 4000/mm3 ; platelets < 100 000/mm3; hematocrit <30%
  • Anomaly of serum bilirubin and creatinin levels
  • History of organ allograft
  • Other pre-existing autoimmune disease
  • Male and female pubescent teenagers under the age of 15
  • Male and female teenagers whose puberty has begun for more than one year
  • Asthmatic patient
  • Pregnant or breastfeeding female patient
  • Participation in another therapeutic trial concurrently or 30 days prior to inclusion

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    IL-2 low dose

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of success: absence of relapse of idiopathic nephrotic syndrome
    Absence of relapse of idiopathic nephrotic syndrome

    Secondary Outcome Measures

    Safety of Interleukin-2
    Study of adverse events
    Increase of regulatory T cells after 5 injections of Interleukin-2
    increase of regulatory T cells (CD4+, CD25+, Foxp3 cells) from baseline to fifth injection, expressed as a percentage
    Increase of regulatory T cells after 18 injections of Interleukin-2
    increase of regulatory T cells (CD4+, CD25+, Foxp3 cells) from baseline to eighteenth injection, expressed as a percentage

    Full Information

    First Posted
    December 15, 2016
    Last Updated
    May 29, 2018
    Sponsor
    University Hospital, Limoges
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02997150
    Brief Title
    Treatment of Steroid Dependent Idiopathic Nephrotic Syndrome in Children With Low Doses of Interleukin 2: a Pilot Study
    Acronym
    NIL-2 pilote
    Official Title
    Treatment of Steroid Dependent Idiopathic Nephrotic Syndrome in Children With Low Doses of Interleukin 2: a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    no treatment available
    Study Start Date
    February 2017 (Anticipated)
    Primary Completion Date
    August 2018 (Anticipated)
    Study Completion Date
    October 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Limoges

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nephrotic Syndrome Steroid-Dependent, Interleukin 2
    Keywords
    Idiopathic nephrotic syndrome-child-steroid dependant-IL2, Safety, Efficacy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    IL-2 low dose
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    IL-2 Low dose
    Intervention 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
    Primary Outcome Measure Information:
    Title
    Number of success: absence of relapse of idiopathic nephrotic syndrome
    Description
    Absence of relapse of idiopathic nephrotic syndrome
    Time Frame
    Day 184
    Secondary Outcome Measure Information:
    Title
    Safety of Interleukin-2
    Description
    Study of adverse events
    Time Frame
    Day 214
    Title
    Increase of regulatory T cells after 5 injections of Interleukin-2
    Description
    increase of regulatory T cells (CD4+, CD25+, Foxp3 cells) from baseline to fifth injection, expressed as a percentage
    Time Frame
    Day 8
    Title
    Increase of regulatory T cells after 18 injections of Interleukin-2
    Description
    increase of regulatory T cells (CD4+, CD25+, Foxp3 cells) from baseline to eighteenth injection, expressed as a percentage
    Time Frame
    Day 184

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Children between 3 and 15 years of age (included) with a steroid responsive idiopathic nephrotic syndrome Idiopathic nephrotic syndrome progressing for less than 1 year Steroid dependent idiopathic nephrotic syndrome (at least 1 relapse when steroids are tapered off or within 3 months after their withdrawal, and reliance on steroids > 15 mg/m² every other day) Steroid dose at inclusion between 15 and 60 mg/m²every other day Patient with a stable dose of steroids within the 8 days before and after the first injection of IL2 Patient in remission for more than 15 days Patient affiliated to a French health insurance Signed consent of parental authority Exclusion Criteria: Hypersensitivity to IL2 or to one of its excipients Significant history or presence of cardiopathy Signs of evolving infection requiring an antibiotic treatment Respiratory distress, respiratory infection or chronic respiratory failure Serious dysfunction of one of the vital organs Leukocytes < 4000/mm3 ; platelets < 100 000/mm3; hematocrit <30% Anomaly of serum bilirubin and creatinin levels History of organ allograft Other pre-existing autoimmune disease Male and female pubescent teenagers under the age of 15 Male and female teenagers whose puberty has begun for more than one year Asthmatic patient Pregnant or breastfeeding female patient Participation in another therapeutic trial concurrently or 30 days prior to inclusion
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vincent Guigonis, MD
    Organizational Affiliation
    University Hospital, Limoges
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Treatment of Steroid Dependent Idiopathic Nephrotic Syndrome in Children With Low Doses of Interleukin 2: a Pilot Study

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