Rituximab, Cyclophosphamide, and Corticosteroids at Low Cumulative Doses to Induce Remission in Primary Membranous Nephropathy
This exploratory study aims to assess the efficacy, safety of the experimental treatment based on a combination of rituximab (RTX), intravenous (IV) cyclophosphamide (CYC), and corticosteroids (S) administrated at lower cumulative doses (RCP) for the induction of early remission in subjects with anti-PLA2R antibody-positive primary membranous nephropathy (PMN) having nephrotic syndrome (NS).
• Age 18-75 years.
• Biopsy-proven primary membranous nephropathy (PMN) defined upon the exclusion of any significant concomitant disease (infectious, autoimmune, neoplastic) by careful clinical work-up at the time of kidney biopsy.
• Signed informed consent
• Increased serum level of anti-PLA2R antibodies (\>20 RU/ml).
• Absence of contraindications to immusuppressive therapy.
• Presence of nephrotic syndrome (NS) with one of the following conditions:
‣ persistence for \>6 months despite treatment with an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker with or without immunosuppression and NS complications.
⁃ persistence for \<6 months at the presence of complications related to NS (thromboembolic or infectious event or estimated GFR by CKD-EPI equation (eGFR) decrease \>20%.
⁃ recurrence after remission with a prior immunosuppressive treatment.
⁃ treatment failure of an alternative immunosuppressive regimen.