Study of Initial Steroid Treatment in Young Children With Nephrotic Syndrome

Steroid-Sensitive Nephrotic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04536181
• Other study ID #: CSICS
• Status: Withdrawn
• Phase: Phase 3
• Start date: January 1, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: December 2020
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Nephrosis
• Nephrotic Syndrome
• Steroid-Sensitive Nephrotic Syndrome
• Syndrome

Intervention

Drug:
• Prednisolone
12 weeks prednisolone treatment
• Placebo
12 weeks simulated tablets

Locations

Country	Name	City	State
China	Children's hospital of Fudan university	Shanghai	Shanghai
China	Shanghai Children's Hospital	Shanghai
China	Shanghai Children's Medical Center	Shanghai
China	Xinhua Hospital, Shanghai Jiaotong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of frequent relapses of nephrotic syndrome at 12th month 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.	12 month period after 3 month standard treatment
Secondary	Number of relapses during 12 months follow up after 3 month standard treatment	Number of nephrotic syndrome relapses per patient year during the 12-month period after 3 month standard treatment	12 month period after 3 month standard treatment
Secondary	Time to first relapse (days)	Number of days from randomization to occurrence of first relapse	12 month period after 3 month standard treatment
Secondary	Cumulative prednisolone [or corticosteroid equivalent] received during 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	12 month period after 3 month standard treatment
Secondary	The use of steroid-sparing medications	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.	12 month period after 3 month standard treatment
Secondary	Adverse events during 12-month period after 3 month standard treatment	Number of adverse events experienced, related or unrelated to corticosteroid use	12 month period after 3 month standard treatment
Secondary	Change in height during 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.	12 month period after 3 month standard treatment
Secondary	Occurrence of steroid-dependent nephrotic syndrome at 12th month 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.	12 month period after 3 month standard treatment