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

Nephrotic Syndrome Steroid-Dependent Clinical Trial

— NIL-2 pilote  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02997150
• Other study ID #: I15041 (NIL-2 pilote)
• Status: Withdrawn
• Phase: Phase 2
• Start date: February 2017
• Est. completion date: October 2018

Study information

• Verified date: May 2018
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Interleukin 2
• Nephrosis
• Nephrosis, Lipoid
• Nephrotic Syndrome
• Nephrotic Syndrome Steroid-Dependent
• Syndrome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of success: absence of relapse of idiopathic nephrotic syndrome	Absence of relapse of idiopathic nephrotic syndrome	Day 184
Secondary	Safety of Interleukin-2	Study of adverse events	Day 214
Secondary	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
Secondary	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