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Clinical Study of Rituximab Combined With Corticosteroids or Rituximab Monotherapy in the Treatment of Primary Membranous Nephropathy

StatusRecruiting
PhasePhase 4
Started
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Record status
This record was last updated April 2, 2024 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv2 Show 11 more changesShow less
    • Primary completion date: Aug 31, 2025 to Sep 30, 2026
    • Start date: Aug 25, 2022 to Mar 29, 2024
    • Primary endpoint revised
    • Enrollment target: 72 to 78
    • Study completion date: Aug 31, 2025 to Dec 31, 2026
    • Interventions: Cyclophosphamide (Drug), Rituximab (Drug) to rituximab (Drug), rituximab combined with corticosteroids (Drug)
    • Eligibility criteria expanded, about 121 words
    • Secondary endpoints: 6 to 8
    • Study description shortened, about 18 words
    • Publications: 7 to 13
    • Study title expanded, about 7 words
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This was a prospective, randomized, multicenter clinical trial. Seventy-eight patients with primary membranous nephropathy (PMN) were randomly divided into intervention or control group. Intervention group was given rituximab combined with corticosteroids in induction therapy and the control group was given rituximab monotherapy. After 6 months, patients who had decreased 24h urinary protein by \> 25% but did not achieve CR were given rituximab maintenance therapy. The complete response rate at 12 months was measured.
Trial Details
NCT Number NCT05514015
Lead Sponsor First Affiliated Hospital, Sun Yat-Sen University
Conditions
(from sponsor)		 Primary Membranous Nephropathy
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov