drugset / Trial / NCT04536181

Study of Initial Steroid Treatment in Young Children With Nephrotic Syndrome

NCT04536181

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a multicentric, prospective, randomized, double blind, placebo controlled trial compared the efficacy of 6 months vs. 3 months of initial prednisolone therapy in decreasing the incidence of FRNS with steroid-sensitive nephrotic syndrome in children age 1 year up to 6 years. Three months tapering prednisolone or placebo are administrated follow by open-label 3 months standard prednisolone therapy.The cumulative incidence of FRNS and adverse events for one year were evaluated in the 3-month and 6-month groups.

Timeline

Start
2021-01-01
Primary completion
2022-09-01
Completion
2022-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Prednisolone Other / unclassified