Research Project

Project Title:

REducing STEroids in Relapsing Nephrotic syndrome (the RESTERN study)

Project Type:

Clinical Trial, Enrolment ongoing

Disease group(s):

Immune glomerulopathies

Project Summary:

Children with nephrotic syndrome are treated with steroids.
As over 80% of the patients experience one or several relapses, patients are exposed to repeated courses of high dosed steroid therapy. Recent studies show that steroid schedules for the first episode of childhood nephrotic syndrome can safely be reduced.
The main hypothesis of the RESTERN study is that relapses of nephrotic syndrome can be treated adequately by a reduced duration of alternate day prednisolone (2 weeks instead of the currently used 4-6 weeks) after a similar induction of remission.
Using an international multicenter double-blind randomized placebo-controlled non-inferiority intervention study, this hypothesis will be tested.
The primary endpoint of the RESTERN study is time to first relapse.

Lead principal investigator(s):

Michiel Schreuder, Nijmegen

Co-investigator(s):

Lutz Weber, Cologne
Rasmus Ehren, Cologne
Elena Levtchenko, Leuven
Johan Walle, Ghent
Lars Pape, Hannover
Jun Oh, Hamburg
Markus Benz, Dachau

Project Period:

12/2016   -   01/2023

Sponsors:

Non-profit foundation

Project web page:

https://www.restern.nl/

EudraCT Nr.:

2016-002430-76

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