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

NCT ID: NCT02997150

Last Updated: 2018-05-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-28
• Study Completion Date: 2018-10-31

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.

Conditions

Nephrotic Syndrome Steroid-Dependent; Interleukin 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IL-2 low dose

Group Type: EXPERIMENTAL

IL-2 Low dose

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Guigonis, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Limoges

Other Identifiers

I15041 (NIL-2 pilote)

Identifier Type: -

Identifier Source: org_study_id