The study will be a randomized, open-label trial in children with the initial episode of SSNS and whose state of complete remission after received standard prednisolone, to determine whether rituximab (a single intravenous infusion of 375 mg/m2) would be noninferior to corticosteroid alone in maintaining complete disease remission during 12-month of follow-up.
Children between 1 and 18 years with Steroid-Sensitive Nephrotic Syndrome (nephrotic-range proteinuria and either hypoalbuminemia or edema when albumin level is not available)
Estimated glomerular filtration rate (eGFR) ≥90 ml/min per 1.73 m2 at study entry
Remission at study entry
the cluster of differentiation antigen 20 (CD20) positive cells in peripheral blood ≥1% total lymphocytes
Diagnosis of secondary NS
Patients showing one of the following abnormal clinical laboratories
values: leukopenia (white blood cell count ≤3.0*109/L); moderate and severe anemia (hemoglobin <9.0g/dL); thrombocytopenia (platelet count <100*1012/ L); positivity of autoimmunity tests (ANA, Anti DNA antibody, ANCA) or reduced C3 levels; Alanine aminotransferase or aspartate aminotransferase > 2.5× upper limit of normal value
Presence of severe or chronic infections within 6 months before assignment: tuberculosis or in whom tuberculosis is suspected; Epstein-Barr virus or cytomegalovirus; hepatitis B or hepatitis C or hepatitis B virus carrier, human immunodeficiency virus or other active viral infections
Parallel
Rituximab
DrugRituximab 375 mg/m2 added to guideline-recommended corticosteroid therapy
Corticosteroid
Drugguideline-recommended corticosteroid therapy
1-year relapse-free survival rate
The rate of no relapse within 1 year. Relapse definition: recurrence of nephrotic-range proteinuria, urine protein/creatinine ratio ≥2 mg/mg or dipstick ≥3+ on 3 consecutive days in the first morning samples.
Time to relapse (days)
Number of days from randomization to occurrence of first relapse. Relapse definition: recurrence of nephrotic-range proteinuria, urine protein/creatinine ratio ≥2 mg/mg or dipstick ≥3+ on 3 consecutive days in the first morning samples.
Peripheral blood T cell subsets
It is a repeat measured variable. Using fluorescence-activated cell sorting, peripheral blood T cells subsets will be studied as percentages and absolute counts.
Peripheral blood B cell subsets
It is a repeat measured variable. Using fluorescence-activated cell sorting, peripheral blood B cells subsets will be studied as percentages and absolute counts.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
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 Fudan University
Lead sponsor
Shanghai Shen Kang Hospital Development Center
Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Shanghai Children's Medical Center
Collaborator
Shanghai Children's Hospital
Collaborator
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