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

NCT02997150 | Withdrawn Phase 2 DMC

• 1 other identifier: I15041 (NIL-2 pilote)
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nephrotic Syndrome Steroid-Dependent; Interleukin 2

Keywords

Idiopathic nephrotic syndrome-child-steroid dependant-IL2; Safety; Efficacy

Outcome Measures

Primary Outcomes (1)

• Number of success: absence of relapse of idiopathic nephrotic syndrome

  Absence of relapse of idiopathic nephrotic syndrome

  Day 184

Secondary Outcomes (3)

• Safety of Interleukin-2

  Day 214

• Increase of regulatory T cells after 5 injections of Interleukin-2

  Day 8

• Increase of regulatory T cells after 18 injections of Interleukin-2

  Day 184

Study Arms (1)

IL-2 low dose

EXPERIMENTAL

Drug: IL-2 Low dose

Interventions

IL-2 Low dose 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

IL-2 low dose

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead

MeSH Terms

Conditions

Nephrotic Syndrome

Interventions

Interleukin-2

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Vincent Guigonis, MD

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 19, 2016
• Study Start: February 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: October 1, 2018
• Last Updated: May 30, 2018

Record last verified: 2018-05