Study of Initial Steroid Treatment in Young Children With Nephrotic Syndrome

• Status: Withdrawn
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Fudan University
• Treatments: Prednisolone; Prednisone

Criteria

Inclusion Criteria:

• Idiopathic, steroid-sensitive, first episode of nephrotic syndrome

• Age 12 months up to 6 years

• Written informed consent

Exclusion Criteria:

• Nephrotic syndrome known to be secondary to a systemic disorder, e.g., Immunoglobulin A (IgA) nephropathy, systemic lupus erythematosus, Henoch Schonlein purpura, vasculitis, , hepatitis B or Alport syndrome.

• Therapy with prednisolone for prior episodes of nephrotic syndrome

• Persistent estimated glomerular filtration rate (GFR) <75 ml/min/1.73 m2

• Patients who show relapse during the first 3 months of pre-randomization corticosteroid therapy for nephrotic syndrome

• Patients with initial steroid resistance

• Patients who are allergic to glucocorticoids

• The compliance of patients or their guardians is poor