Clinical Trial

Rituximab in the First Episode of Paediatric Nephrotic Syndrome

Not Yet Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated January 22, 2025 (before its estimated July 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-05-06; most recent amendment 2025-01-21.
Trial Details
NCT Number NCT05850546
Lead Sponsor Children's Hospital of Fudan University
Collaborators: Shanghai Shen Kang Hospital Development Center, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Children's Medical Center, Shanghai Children's Hospital
Conditions Steroid-Sensitive Nephrotic Syndrome
Enrollment 138 participants
Start Date 2025-03-01
Primary Completion 2026-07-30 (estimated)
Study Completion 2026-12-28 (estimated)
Updated on ClinicalTrials.gov 2025-01-22