The main objective is to demonstrate, from the initial episode of nephrotic syndrome (NS) in children with standard prednisolone treatment, once complete remission has occurred, that the use of Rituximab (a single intravenous infusion of 375 mg/m2) may reduce the risk of subsequent relapse during 12-month of follow-up.
NS is the most frequent glomerular disease in children. Between 80% and 90% of children with steroid-sensitive nephrotic syndrome (SSNS) will relapse following an initial response to corticosteroids. Half of these children will experience frequent relapses (FRNS) or become steroid-dependent (SDNS). 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 FRNS/SDNS without corticosteroid or immunosuppressive therapy. To the investigators' knowledge, Rituximab has never been investigated for the initial episode of NS with the aim to reduce the subsequent risk of relapse that is a major concern in the management of children with NS. Children aged 1-18 years with the first episode of the SSNS will be treated with a single intravenous infusion of Rituximab 375 mg/m2. The prednisolone at a dose of 2 mg/kg per day (maximum 60 mg in single or divided doses) for 6 weeks, followed by 1.5 mg/kg (maximum 40 mg) as a single morning dose on alternate days for the next 6 weeks; therapy is then discontinued.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Rituximab (375 mg/m2) will be given as a single intravenous infusion after remission
Anhui Provincial Children's Hospital
Hefei, Anhui, China
Children's Hospital Affiliated to Zhengzhou University/Henan Children's Hospital
Zhengzhou, Henan, China
Wuhan Children's Hospital,Tongji Medical College, Huazhong University of Science and Technology.
Wuhan, Hubei, China
1-year relapse-free survival rate
The rate of no relapse within 1 year
Time frame: 1-year period after randomization
Time to relapse (days)
Number of days from randomization to occurrence of first relapse
Time frame: 1-year period after administration of rituximab therapy
Proportion of patients with a relapse
The proportion of patients with relapse
Time frame: 6 months period after administration of rituximab therapy
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 administration of rituximab therapy
The effect of rituximab on peripheral blood B cell subsets and T cell subsets to highlight biomarkers useful for monitoring response to rituximab treatment.
Using fluorescence-activated cell sorting (FACS), peripheral blood B cell subsets and T cell subsets will be measured as at baseline, before and after infusion of rituximab at 3,6,12 months, and when relapse.
Time frame: 1-year period after administration of rituximab therapy
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
It is a binary variable (1/0). The variable would be setted as "1" if any adverse events occurs including infusion-related reactions, infection (upper respiratory tract infection, hepatitis B virus reactivation, herpes zoster infection, pneumocystis pneumonia, etc), persistent hypogammaglobulinaemia, encephalopathy, severe neutropenia, fatal pulmonary fibrosis, ulcerative colitis, Crohn's disease and fulminant myocarditis etc. Adverse events will be graded according to the Common Terminology Criteria for Adverse Events
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Children's Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The First Affiliated Hospital of Zhongshan University
Guanzhou, China
Shandong Provincial Hospital Affiliated to Shandong University
Shandong, China
Children's Hospital of Fudan University
Shanghai, China
Xuzhou Children's Hospital
Xuzhou, China
Time frame: 1-year period after administration of rituximab therapy