Study of Initial Steroid Treatment in Young Children With Nephrotic Syndrome

Phase 3

Withdrawn

• Conditions: Steroid-Sensitive Nephrotic Syndrome
• Interventions: Drug: Placebo; Drug: Prednisolone

• Registration Number: NCT04536181
• Lead Sponsor: Children's Hospital of Fudan University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-28
• Study First Posted: 2020-09-02
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-14
• Last Update Posted: 2020-12-17
• Study Start: 2021-01-01
• Primary Completion: 2022-09-01
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Idiopathic, steroid-sensitive, first episode of nephrotic syndrome
• Age 12 months up to 6 years
• Written informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 months group	Placebo	Subjects will receive 12-weeks of placebo following randomization
6 months group	Prednisolone	12 Weeks of Prednisolone Therapy Subjects will add an additional 12 weeks of Prednisolone to follow pre-randomization standard of care prednisolone.

Primary Outcome Measures

Name	Time	Method
Occurrence of frequent relapses of nephrotic syndrome at 12th month after 3 month standard treatment	12 month period after 3 month standard treatment	Proportion of patients with frequent relapses at 12th month after 3 month standard treatment.Frequent relapses nephrotic syndrome was defined as two or more relapses within 6 months after completing initial treatment, or four relapses within any period of 12 months, including relapses during initial treatment.

Secondary Outcome Measures

Name	Time	Method
The use of steroid-sparing medications	12 month period after 3 month standard treatment	The proportion of patients in each study arm treated with steroid-sparing strategies or medications.it is a binary varibale (1/0). The variable wolud be sette into "1", if the patients use the steroid-sparing medications such as cyclophosphamide, levamisole, mycophenolate mofetil，rituximab and so on.
Adverse events during 12-month period after 3 month standard treatment	12 month period after 3 month standard treatment	Number of adverse events experienced, related or unrelated to corticosteroid use
Change in height during 12-month period after 3 month standard treatment	12 month period after 3 month standard treatment	The standard deviation scores (SDS) for height will be measured at 12th month and randomization. Change in height is SDS at 12 month minus that of randomization.
Number of relapses during 12 months follow up after 3 month standard treatment	12 month period after 3 month standard treatment	Number of nephrotic syndrome relapses per patient year during the 12-month period after 3 month standard treatment
Time to first relapse (days)	12 month period after 3 month standard treatment	Number of days from randomization to occurrence of first relapse
Cumulative prednisolone [or corticosteroid equivalent] received during 12 month period after 3 month standard treatment	12 month period after 3 month standard treatment	Total amount of prednisolone \[or corticosteroid equivalent\] received, as mg/kg/day or mg/m2/day as intervention and for treatment of relapses, during 12 months follow up after 3 month standard treatment
Occurrence of steroid-dependent nephrotic syndrome at 12th month after 3 month standard treatment	12 month period after 3 month standard treatment	Proportion of patients with steroid-dependent nephrotic syndrome at 12th month after 3 month standard treatment.Steroid-dependent nephrotic syndrome was defined as steroid-sensitive nephrotic syndrome with 2 or more consecutive relapses during tapering or within 14 days of stopping steroids.

Trial Locations

Locations (4)

Xinhua Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, China

Children's hospital of Fudan university; 🇨🇳 Shanghai, Shanghai, China

Shanghai Children's Hospital; 🇨🇳 Shanghai, China

Shanghai Children's Medical Center; 🇨🇳 Shanghai, China