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Withdrawn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
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
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
NCT ID
NCT02997150
First Posted
December 15, 2016
Last Updated
May 29, 2018
Sponsor
University Hospital, Limoges
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
We'll reach out to this number within 24 hrs