Comparing Rituximab and Cyclophosphamide Plus Prednisone for Treating Idiopathic Membranous Nephropathy A 24-Month Prospective Study of Immunosuppressive Therapies

What this Trial Is About

Researchers are evaluating the effectiveness of different immunosuppressive treatments in adults with idiopathic membranous nephropathy iMN, a kidney condition. This study compares the long-term remission rates at 24 months between two main treatments cyclophosphamide combined with corticosteroids and rituximab RTX. Previous trials showed varying remission rates, and this study aims to clarify which treatment approach offers better outcomes, especially considering repeated doses of RTX may improve response. Participants receive one of two treatment plans. The first involves prednisone at 1mgkgday orally, tapered after 2 months and stopped over 6 to 12 months, plus cyclophosphamide at 1-2mgkgday with a total dose target of 12g. Optional medications like azathioprine or mycophenolate mofetil may be given if remission is not achieved by 6 months. The second plan uses rituximab 1000mg intravenously on Day 1 and at 6 months, with possible repeated doses every 6 months for patients who respond but do not fully remit. Rituximab dosing may be adjusted based on CD19 B cell counts. Optional calcineurin inhibitors are tapered and stopped by 9 months. Throughout the study, participants are monitored for remission status at multiple time points up to 24 months, kidney function changes, relapse rates, and levels of relevant blood markers such as anti-PLA2R and CD19 B cells. Safety and adverse events are recorded during the entire period. This prospective cohort study allows researchers to compare how these treatments perform and assess the time to remission and kidney health over two years.

Different Immunosuppressive Treatment in iMN