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Rituximab in the First Episode of Paediatric Nephrotic Syndrome
Sponsor: Children's Hospital of Fudan University
Summary
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.
Official title: Efficacy and Safety of Single-dose Rituximab Biosimilar in the Initial Episode of Paediatric Steroid-sensitive Nephrotic Syndrome: A Multicenter, Open-Label, Noninferiority, Randomized Controlled Trial
Key Details
Gender
All
Age Range
1 Year - 18 Years
Study Type
INTERVENTIONAL
Enrollment
138
Start Date
2025-03-01
Completion Date
2026-12-28
Last Updated
2025-01-22
Healthy Volunteers
Yes
Conditions
Interventions
Rituximab
Rituximab 375 mg/m2 added to guideline-recommended corticosteroid therapy
Corticosteroid
guideline-recommended corticosteroid therapy
Locations (3)
Children's hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai's Children's Medical Center
Shanghai, Shanghai Municipality, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China