Observational Study on Treatment and Effectiveness of Rituximab and Hormones in Adults with Primary Membranous Nephropathy

What this Trial Is About

This research focuses on primary membranous nephropathy PMN, a kidney condition, by comparing how well rituximab combined with hormones works versus rituximab alone. The study is designed as a randomized, controlled, multicenter clinical trial, and also includes a real-world observation of patients who do not meet trial criteria or choose not to join the main study, to better understand treatment effects across a wider group. Participants will receive treatment following established clinical protocols, either rituximab with hormones or rituximab alone. Alongside treatment, the study will explore changes in kidney and blood at genetic and molecular levels, including genome-wide, transcriptome, proteome, metabolome, and microbiome shifts. Researchers will also analyze kidney pathology images to predict which patients might respond best to rituximab. During the study, participants will be monitored for treatment response over 24 months, with key measures including complete response rates at 12 months, remission times, recurrence rates, medication doses, immune cell counts, kidney function, and adverse events. This includes regular evaluations of laboratory tests and clinical outcomes to assess treatment safety and effectiveness. The study starts in November 2024 and continues until November 2027.

A Real World Study About PMN