The aim of this study is to evaluate the efficacy and safety of maintenance Mycophenolate Mofetil following single course of Rituximab in maintaining remission over 12 months among Children with frequently-relapsing or steroid-dependent nephrotic syndrome
The results of multiple observational studies and randomized control trials have shown that Rituximab, a chimeric monoclonal antibody against the cluster of differentiation antigen 20 (CD20) antigen on B cells, is safe and effective for children with complicated steroid-dependent/ frequently-relapsing nephrotic syndrome (SDFRNS) without corticosteroid or immunosuppressive therapy. Single rituximab infusion has been shown to be efficacious for 6 to 12 months, the reported median relapse-free period was 9 months. Our previous study found that Mycophenolate mofetil can further improve the sustained remission time. All patients will be treated with 2 doses of Rituximab 375 mg/m2 iv at time 0 and 7 days. Addition of Maintenance Mycophenolate Mofetil or placebo from 4 Month onwards. The expected duration of the follow-up is 12 months, consisting of 12 visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Rituximab: 375 mg/m2 intravenously on day 0 and day 7
Addition of Maintenance Mycophenolate Mofetil from 4 Month onwards. Dose: 20\~30mg/kg/day,BID. Total duration : 8 months.
Addition of Maintenance Placebo tablets matching Mycophenolate Mofetil from 4 Month onwards. Dose: 20\~30mg/kg/day,BID. Total duration : 8 months.
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
1-year relapse-free survival rate
The rate of no relapse within 1 year
Time frame: 1-year period after randomization
The concentration for MPA-area under curve(AUC)
Blood concentrations of mycophenolic acid (MPA)
Time frame: At 48 weeks
Proportion of patients with a relapse
The proportion of patients with relapse
Time frame: 6 months period after randomization
Time to relapse (days)
Number of days from randomization to occurrence of first relapse
Time frame: 1-year period after randomization
B-Cell Recovery Time
Time to the first detection of CD19+ cells above 1% of total CD45+ lymphocytes after CD19+ cell depletion
Time frame: 1-year period after randomization
Change in growth velocity
The standard deviation scores (SDS) for height at 12th month minus that of randomization.
Time frame: 1-year period after randomization
adverse events
It is a binary variable (1/0). The varibale would be setted as "1" if any adverse events occours including early infusion termination, acute infusion reaction Infection, pulmonary fibrosis, encephalopathy, neutropenia. Adverse events graded according to Common Terminology Criteria For Adverse Events (NCI-CTCAE v4.03)
Time frame: 1-year period after randomization
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