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REducing STEroids in Relapsing Nephrotic syndrome: the RESTERN study- protocol of a national, double-blind,
A M Schijvens1, E M Dorresteijn2, N Roeleveld3
1Department of Pediatric Nephrology, Radboudumc Amalia Children's Hospital, Nijmegen, The Netherlands.
Insights
Reducing steroid exposure in childhood nephrotic syndrome relapses is crucial. The RESTERN study investigates a shorter, 4-week prednisolone regimen, aiming to reduce side effects while maintaining treatment efficacy.
Area of Science:
- Pediatric Nephrology
- Clinical Pharmacology
- Immunosuppressive Therapy
Background:
- Idiopathic childhood nephrotic syndrome (ICNS) often requires repeated oral corticosteroid courses, leading to significant side effects and complications.
- Current treatment protocols for ICNS relapses necessitate optimizing corticosteroid regimens to minimize long-term adverse events.
- Limited randomized controlled trials exist for optimal corticosteroid treatment during infrequent ICNS relapses.
Purpose of the Study:
- To evaluate the efficacy and safety of a reduced 4-week alternate-day steroid regimen compared to standard therapy in children with relapsing nephrotic syndrome.
- To determine if a shortened steroid schedule can reduce overall steroid exposure by an average of 35% without compromising treatment outcomes.
- To assess the impact of reduced steroid duration on the time to first relapse and the progression to frequent or steroid-dependent nephrotic syndrome.
Main Methods:
- The REducing STEroids in Relapsing Nephrotic syndrome (RESTERN) study is a nationwide, double-blind, randomized, placebo-controlled, non-inferiority trial.
- 144 children aged 1-18 years with relapsing steroid-sensitive nephrotic syndrome were randomized to standard or reduced prednisolone schedules.
- Primary outcome: time to first relapse post-treatment; Secondary outcomes: relapse frequency, progression to frequent/steroid-dependent disease, and cumulative prednisolone dosage.
Main Results:
- The study is designed as a non-inferiority trial to assess if the reduced regimen is non-inferior to standard therapy.
- Primary and secondary outcome data will be analyzed to compare the effectiveness and safety profiles of both treatment arms.
- Results will determine if the 4-week reduction in alternate-day steroids is a safe and effective alternative, reducing steroid burden.
Conclusions:
- The RESTERN study aims to provide evidence for a safer, less toxic corticosteroid treatment strategy for relapsing nephrotic syndrome in children.
- Findings are expected to inform clinical practice guidelines, potentially leading to reduced long-term complications associated with prolonged steroid use.
- Successful completion and publication of the RESTERN study will offer valuable insights into optimizing steroid therapy for pediatric nephrotic syndrome.
Introduction:
Oral corticosteroids are the first-line treatment for idiopathic childhood nephrotic syndrome. Most children experience several relapses, needing repeated courses of corticosteroid therapy. This exposes them to side effects and long-term complications. For most patients, long-term prognosis is for complete resolution of the disease over time and maintenance of normal kidney function. Therefore, it is vital to focus on minimising adverse events of the disease and its therapy. Unfortunately, no randomised 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 shortened to 2 months. The hypothesis of the REducing STEroids in Relapsing Nephrotic syndrome (RESTERN) study is that a 4-week reduction of alternate-day steroids after inducing remission is effective and safe, reduces steroid exposure by 35% on average and is therefore preferable.
Methods And Analysis:
The RESTERN study is a nationwide, double-blind, randomised, placebo-controlled, non-inferiority intervention study. Children aged 1-18 years with a relapse of steroid-sensitive nephrotic syndrome are eligible for this study. Study subjects (n=144) will be randomly assigned to either current standard therapy in the Netherlands or a reduced prednisolone schedule. The primary outcome of the RESTERN study is the time to first relapse after the final prednisolone dose. The secondary outcomes are the number or relapses, progression to frequent relapsing or steroid dependent nephrotic syndrome and the cumulative dosage of prednisolone during the study period.
Ethics And Dissemination:
This non-inferiority trial will be performed in accordance with the Declaration of Helsinki and has been approved by the medical ethical committee of Arnhem-Nijmegen and the Dutch Competent Authority (Central Committee on Research Involving Human Subjects, CCMO). After completion of this study, results will be published in national and international peer-reviewed scientific journals. Papers will be published according to CCMO guidelines. The final report will be made available to trial participants.
Trial Registration Number:
NTR5670, EudraCT no 2016-002430-76.
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