A prospective observational study to assess the efficacy and safety of low dose corticosteroids, cyclophosphamide and rituximab in patients with primary membranous nephropathy

Despite immunosuppressive therapy, one third of patients with Primary Membranous Nephropathy (PMN) progress to kidney failure, requiring dialysis or transplantation. The standard treatment—cyclical corticosteroid and cyclophosphamide—is effective but toxic, and rituximab fails in 40% of cases. Thus, safer, equally effective alternatives are needed. Novelty: This pilot study has been planned to assess the combination of low-dose corticosteroid and cyclophosphamide, and rituximab in primary MN. It also enables subgroup analyses based on clinical variables such as proteinuria, serum albumin, and anti-PLA2R titre. Objective: To study the efficacy of low-dose corticosteroid and cyclophosphamide and rituximab PMN, assessing the response rates, adverse events, and quality of life (QOL). Methodology: This trial is a prospective multi-centre observational study planned to be conducted at Department of Nephrology, PGIMER, Chandigarh, and Department of Nephrology, Army Hospital (Research and Referral), New Delhi. Eligible participants (adults more than or equal to 18 years of age) will receive low-dose corticosteroid, cyclophosphamide, and rituximab. Patients will be followed up for a period of 18 months to study the efficacy in achieving clinical and immunological remission, adverse event profile, and QOL. Primary Outcome**:** The primary endpoint comprises response in the form of efficacy—complete or partial remission. Secondary Outcome: (a)To estimate Adverse events: Count of serious adverse events (SAE) or nonserious adverse events of special interest (NSAESI), (b)Immunological remission (anti-PLA2R positive participants), (c)Quality of life (36-Item Short Form Survey Instrument Questionnaire: SF-36)