Clinical trial NCT02997150: Treatment of Steroid Dependent Idiopathic Nephrotic Syndrome in Children With Low Doses of Interleukin 2: a Pilot Study
Official title: Treatment of Steroid Dependent Idiopathic Nephrotic Syndrome in Children With Low Doses of Interleukin 2: a Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Nephrotic Syndrome Steroid-Dependent
Interleukin 2
Keywords: Idiopathic nephrotic syndrome-child-steroid dependant-IL2
Safety
Efficacy
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of success: absence of relapse of idiopathic nephrotic syndrome
timeFrame: Day 184
Secondary outcomes:
measure: Safety of Interleukin-2
timeFrame: Day 214
measure: Increase of regulatory T cells after 5 injections of Interleukin-2
timeFrame: Day 8
measure: Increase of regulatory T cells after 18 injections of Interleukin-2
timeFrame: Day 184
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Limoges
name: Vincent Guigonis, MD
role: PRINCIPAL_INVESTIGATOR
References: