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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
12 weeks prednisolone treatment
12 weeks simulated tablets
Children's hospital of Fudan university
Shanghai, Shanghai Municipality, China
Shanghai Children's Hospital
Shanghai, China
Shanghai Children's Medical Center
Shanghai, China
Xinhua Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
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.
Time frame: 12 month period after 3 month standard treatment
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
Time frame: 12 month period after 3 month standard treatment
Time to first relapse (days)
Number of days from randomization to occurrence of first relapse
Time frame: 12 month period after 3 month standard treatment
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
Time frame: 12 month period after 3 month standard treatment
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.
Time frame: 12 month period after 3 month standard treatment
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Adverse events during 12-month period after 3 month standard treatment
Number of adverse events experienced, related or unrelated to corticosteroid use
Time frame: 12 month period after 3 month standard treatment
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.
Time frame: 12 month period after 3 month standard treatment
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.
Time frame: 12 month period after 3 month standard treatment