eligibility_summary
Adults ≥18 with biopsy-proven fibrillary glomerulonephritis, proteinuria >1 g/day (pre-immunosuppression), and eGFR ≥20. Exclude secondary FGN or other renal pathology, HBV/HCV/HIV, pregnancy/breastfeeding, active infection, kidney transplant, Hgb <8 g/dL, platelets <100k, other contraindications, recent cyclophosphamide (≤6 mo), ACTH/MMF (≤30 d), prednisone >10 mg/d (≤15 d), prior rituximab with CD20 <5/µL. Contraception/abstinence: women 18 mo after, men 6 mo.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drug/intervention: Obinutuzumab (Gazyva), a glycoengineered humanized type II anti-CD20 IgG1 monoclonal antibody (immunotherapy). Dosing: 1 g IV on day 1 and day 15, repeated at month 6. Mechanism of action: Depletes CD20+ B cells via enhanced antibody-dependent cellular cytotoxicity/phagocytosis and direct non-complement cell death (lower CDC than rituximab), leading to reduced autoantibody production and immune complex formation. Cells/pathways targeted: CD20-expressing B lymphocytes and the humoral immune response driving IgG/complement (e.g., C3) deposition in glomeruli, aiming to mitigate immune complex–mediated glomerular injury and proteinuria in fibrillary glomerulonephritis. Phase 2, single-arm, open-label.