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

Phase 2

Withdrawn

• Conditions: Interleukin 2; Nephrotic Syndrome Steroid-Dependent
• Interventions: Drug: IL-2 Low dose

• Registration Number: NCT02997150
• Lead Sponsor: University Hospital, Limoges

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.

Study Timeline

• Study First Submitted: 2016-12-15
• Study First Submitted QC: 2016-12-15
• Study First Posted: 2016-12-19
• Study Start: 2017-02
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-29
• Last Update Posted: 2018-05-30
• Primary Completion: 2018-08
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IL-2 low dose	IL-2 Low dose	-

Primary Outcome Measures

Name	Time	Method
Number of success: absence of relapse of idiopathic nephrotic syndrome	Day 184	Absence of relapse of idiopathic nephrotic syndrome

Secondary Outcome Measures

Name	Time	Method
Increase of regulatory T cells after 5 injections of Interleukin-2	Day 8	increase of regulatory T cells (CD4+, CD25+, Foxp3 cells) from baseline to fifth injection, expressed as a percentage
Safety of Interleukin-2	Day 214	Study of adverse events
Increase of regulatory T cells after 18 injections of Interleukin-2	Day 184	increase of regulatory T cells (CD4+, CD25+, Foxp3 cells) from baseline to eighteenth injection, expressed as a percentage