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OBINOTUZUMAB Versus Cyclophosphamide + Glucocorticoids in Primary Membranous Nephropathy(Blossom Study)

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Primary endpoint revised
    • Interventions: Cyclophosphamide (CTX) (Drug), Glucocorticoids (Drug) to CTX combined with Glucocorticoids (Drug), Obinutuzumab (Drug)
    • Eligibility criteria shortened, about 468 words
    • Secondary endpoints: 29 to 8
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a randomized, parallel group, active-controlled, open-label, Phase III study comparing the efficacy and safety of obinutuzumab versus cyclophosphamide combined with glucocorticoids in patients with primary membranous nephropathy (pMN). Approximately 144 patients with pMN who have been diagnosed by biopsy or serum anti-PLA2R antibody will be enrolled. Intervention: Intravenous infusion of 1,000 mg obinutuzumab at weeks 0, 2, 24 and 26 Comparator: Cyclical cyclophosphamide and glucocorticoids Methylprednisolone 500 mg iv will be given for 3 consecutive days at the start of month 1,3,5 and followed by prednisone 0.5mg/kg/d (max 40 mg/d) for 27 days. Oral cyclophosphamide will be given for 30 days in month 2, 4, 6.
Trial Details
NCT Number NCT06781944
Lead Sponsor Huashan Hospital
Conditions
(from sponsor)		 Primary Membranous Nephropathy
Enrollment 144 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov