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Study of Telitacicept in Patients With Refractory IgA Nephropathy

StatusUnknown
PhasePhase 2/3
Started
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Record status
This record was last updated February 24, 2023 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Oct 2022); last known: Not Yet Recruiting
  2. Changed Sponsor changed: Second Affiliated Hospital, School of Medicine, Zhejiang University to Second Affiliated Hospital, Zhejiang University, School of Medicine
  3. Phase: Phase 3 to Phase 2/3v2 Show 5 more changesShow less
    • Enrollment target: 182 to 40
    • Start date: Jan 1, 2023 to Mar 1, 2023
    • Interventions: Placebo (Drug), Telitacicept (Drug) to Telitacicept (Drug)
    • Study arms: 2 to 1
    • Study title shortened, about 1 word
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this clinical trial is to explore the effectiveness and safety of Telitacicept in adults with refractory IgA nephropathy. The main questions it aims to answer are: * To evaluate the clinical efficacy of Telitacicept in patients with refractory IgA nephropathy. * To evaluate the safety and adverse reaction of Telitacicept in patients with refractory IgA nephropathy. Participants will be subcutaneously injected with 240mg of Telitacicept once per week. Study subject: After 6 months of sequential treatment with renin-angiotensin system (RAS) blockers or glucocorticoids, patients with pathological biopsy of 0.7≥5 g/24 hours of proteinuria was confirmed as refractory IgA nephropathy.
Trial Details
NCT Number NCT05596708
Lead Sponsor Second Affiliated Hospital, Zhejiang University, School of Medicine
Conditions
(from sponsor)		 IgA Nephropathy
Related terms Glomerulonephritis, IGA
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov