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Rituximab in the First Episode of Paediatric Nephrotic Syndrome

StatusNot Yet Recruiting
PhasePhase 3
Started
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.

Record History

  1. Start date: Sep 1, 2024 to Mar 1, 2025
    • Primary completion date: May 30, 2026 to Jul 30, 2026
    • Study completion date: Sep 28, 2026 to Dec 28, 2026
    v6
  2. Start date: Apr 1, 2024 to Sep 1, 2024
    • Primary completion date: Jan 30, 2026 to May 30, 2026
    • Study completion date: Feb 28, 2026 to Sep 28, 2026
    v5
  3. Start date: Jan 1, 2024 to Apr 1, 2024
    • Primary completion date: Nov 30, 2025 to Jan 30, 2026
    • Study completion date: Dec 30, 2025 to Feb 28, 2026
    v4
  4. Start date: Sep 1, 2023 to Jan 1, 2024v3
  5. Start date: May 1, 2023 to Sep 1, 2023v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Steroid-Sensitive Nephrotic Syndrome
Related terms Nephrotic Syndrome, Recurrence
Enrollment 138 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov