eligibility_summary
Inclusion: 18–75, biopsy‑confirmed primary MN, 24‑h UPCR ≥3.5 g/g, eGFR ≥40, stable ACEi/ARB ≥4 wks, WOCBP: negative test + contraception. Exclusion: secondary MN, diabetic nephropathy, severe rituximab allergy, prior resistance to cyclosporine/cyclophosphamide or CD20 therapy, PMN Ab‑negative, >50% UPCR drop during screening, abnormal labs, HBV/HCV/HIV/TB or active/recent serious infection, cardiac/resp disease, uncontrolled HTN/DM, recent cancer/live vaccine/major surgery, pregnancy/lactation, other trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, randomized, open-label study in primary membranous nephropathy comparing Zuberitamab (HS006) vs cyclosporine. Zuberitamab: an investigational anti-CD20 monoclonal antibody (B-cell–depleting, likely humanized IgG) given 600 mg or 1000 mg IV on Day 1 and Day 15 (24-week cycle). Mechanism: targets CD20 on B lymphocytes to reduce autoantibody production (e.g., anti-PLA2R), lowering immune complex formation and complement-mediated podocyte injury. Comparator cyclosporine: oral calcineurin inhibitor (3.5 mg/kg/day, q12h) that blocks calcineurin–NFAT signaling to suppress T-cell activation and also stabilizes podocyte cytoskeleton, reducing proteinuria. Targets: CD20+ B cells, autoantibody/complement pathways, T-cell activation, and podocyte stability.