REduceren van STEroiden bij kinderen met een Recidief Nefrotisch syndroom – de RESTERN studie

Recruiting

• Conditions: ephrotic syndromeNefrotisch syndroom

• Registration Number: NL-OMON20897
• Lead Sponsor: Dr. Michiel F Schreuder, MD PhDPediatric NephrologistRadboudumc Amalia Children's HospitalDepartment of Pediatric Nephrology, 804P.O.Box 9101, 6500 HB NijmegenThe Netherlands

Brief Summary

Schijvens AM, Dorresteijn EM, Roeleveld N, Ter Heine R, van Wijk JAE, Bouts AHM, Keijzer-Veen MG, van de Kar N, van den Heuvel L, Schreuder MF. REducing STEroids in Relapsing Nephrotic syndrome: the RESTERN study- protocol of a national, double-blind, randomised, placebo-controlled, non-inferiority intervention study. BMJ Open. 2017

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 144

Inclusion Criteria

• Age over 1 and less than 18 years

• Steroid sensitive nephrotic syndrome. This will include the following groups:

Exclusion Criteria

• Steroid resistant nephrotic syndrome;

• Documented or suspected significant non-compliance.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to first relapse after study randomization (censored at 12 and 24 months)

Secondary Outcome Measures

Name	Time	Method
• Number of relapses after study randomization at 12 or 24 months<br /><br>• Development of frequent relapsing nephrotic syndrome according to KDIGO criteria (four or more relapses in any 12-month period)<br /><br>• Development of steroid dependent nephrotic syndrome according to KDIGO criteria (two consecutive relapses during corticosteroid therapy, or within 14 days of ceasing therapy)<br /><br>• Cumulative dosage of prednisone during study period (at 12 and 24 months)