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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: University Hospital, Limoges

Current Primary Outcome: Number of success: absence of relapse of idiopathic nephrotic syndrome [ Time Frame: Day 184 ]

Absence of relapse of idiopathic nephrotic syndrome


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Safety of Interleukin-2 [ Time Frame: Day 214 ]
    Study of adverse events
  • Increase of regulatory T cells after 5 injections of Interleukin-2 [ Time Frame: Day 8 ]
    increase of regulatory T cells (CD4+, CD25+, Foxp3 cells) from baseline to fifth injection, expressed as a percentage
  • Increase of regulatory T cells after 18 injections of Interleukin-2 [ Time Frame: Day 184 ]
    increase of regulatory T cells (CD4+, CD25+, Foxp3 cells) from baseline to eighteenth injection, expressed as a percentage


Original Secondary Outcome: Same as current

Information By: University Hospital, Limoges

Dates:
Date Received: December 15, 2016
Date Started: February 2017
Date Completion: October 2018
Last Updated: December 15, 2016
Last Verified: December 2016