NCT02997150

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Hospital, Limoges · Academic / Other
• Sex: All
• Age: 3 Years – 15 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-02-01
• Primary completion: 2018-08-01
• Completion: 2018-10-01
• First posted: 2016-12-19
• Last updated: 2018-05-30