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
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