ESPN 50th Annual Meeting

ESPN 2017


 
Steroid treatment reduction in relapsing childhood nephrotic syndrome: a new nation-wide randomized controlled trial in the Netherlands - the RESTERN study
ANNE SCHIJVENS 1 MICHIEL SCHREUDER 1

1- DEPARTMENT OF PEDIATRIC NEPHROLOGY, RADBOUDUMC AMALIA CHILDREN’S HOSPITAL, NIJMEGEN, THE NETHERLANDS
 
Introduction:

Nephrotic syndrome is the most common glomerular disorder in childhood. Corticosteroids are the first-line treatment for nephrotic syndrome in children as over 80-90% of patients achieves complete remission after prednisolone treatment. Yet, over 80% experience one or more relapses, necessitating repeated courses of corticosteroid therapy. This exposes patients to severe side effects and long term complications. No randomized controlled trials are available to determine the optimal corticosteroid treatment of an infrequent relapse of nephrotic syndrome. Recent studies show that treatment schedules for the first episode can safely be reduced. The hypothesis of the REducing STEroids in Relapsing Nephrotic syndrome (RESTERN) study is that a 4-week reduction of alternate day steroids is effective and safe, reduces steroid exposure by 35% on average, and is therefore preferable.

Material and methods:

The RESTERN study is a nation-wide, double-blind, randomized, placebo controlled, noninferiority intervention study. Children aged 1-18 years with a relapse of steroid sensitive nephrotic syndrome (n=144) are randomly assigned to either the current standard therapy in the Netherlands (prednisolone daily until remission, than 6 weeks on alternate days) or a reduced prednisolone schedule (prednisolone daily until remission, than 2 weeks on alternate days, followed by 4 weeks of placebo on alternate days).

Results:

The primary endpoint of the RESTERN study is the time to the first relapse. The secondary end points are the number of relapses, progression to frequent relapsing or steroid dependent nephrotic syndrome and the cumulative dosage of prednisolone during the study period of 48 months follow-up.

Conclusions:

The results of the RESTERN study may provide evidence-based recommendations for national and international guidelines to treat children with relapsing nephrotic syndrome. If corticosteroid exposure could be reduced, this would reduce toxicity of prednisolone and thereby decrease the side effects and long-term complications associated with corticosteroid therapy in children with relapsing nephrotic syndrome.