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

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.

Study Overview

• Status: Withdrawn
• Conditions: Nephrotic Syndrome Steroid-Dependent; Interleukin 2
• Intervention / Treatment: Drug: IL-2 Low dose

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 Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: IL-2 low dose

Drug: IL-2 Low dose; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of success: absence of relapse of idiopathic nephrotic syndrome	Absence of relapse of idiopathic nephrotic syndrome	Day 184

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Interleukin-2	Study of adverse events	Day 214
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	Day 8
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	Day 184

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2017
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: December 15, 2016
• First Submitted That Met QC Criteria: December 15, 2016
• First Posted (Estimate): December 19, 2016

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 29, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Idiopathic nephrotic syndrome-child-steroid dependant-IL2
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease; Syndrome; Nephrotic Syndrome; Nephrosis
• Other Study ID Numbers: I15041 (NIL-2 pilote)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No