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, Amsterdam Johan Walle, Ghent Lars Pape, Essen 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 |