NCT04536181

Study of Initial Steroid Treatment in Young Children With Nephrotic Syndrome

Comparative Study of 3 or 6 Months Initial Steroid Treatment in Children Under 6 Years of Age With Steroid Sensitive Nephrotic Syndrome：a Randomized, Double-blind, Placebo-controlled Study

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 1 Year – 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Steroid-Sensitive Nephrotic Syndrome

Interventions

Type	Name	Description
DRUG	Prednisolone	12 weeks prednisolone treatment
DRUG	Placebo	12 weeks simulated tablets

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-09-01
• Completion: 2022-10-01
• First posted: 2020-09-02
• Last updated: 2020-12-17

Locations

4 sites across 1 country: China