Study of Artificial Intelligence-based Personalized Rituximab Treatment Protocol in Membranous Nephropathy

What this Trial Is About

Membranous nephropathy is an autoimmune disease that affects the kidneys and is a leading cause of nephrotic syndrome in non-diabetic Caucasian adults. Its progression varies widely, ranging from spontaneous recovery to chronic kidney disease. Researchers are studying rituximab, an immunosuppressive drug identified as a first-line treatment, but up to 40% of patients do not respond to the initial course. This trial aims to use a machine learning algorithm to predict patients at risk of having low rituximab blood levels after three months, to personalize treatment and improve outcomes. Participants will receive rituximab infusions with dosing based on their risk level determined by the algorithm. Standard treatment includes two 1-gram infusions on day 0 and day 15. Those with moderate risk (51-75%) receive an additional infusion at day 30, and those with high risk (76-100%) receive two additional infusions at day 30 and day 45. This personalized approach is compared to the standard two-dose regimen. The study is randomized without masking and includes a follow-up period to assess the impact of these different dosing strategies. During the study, participants will be monitored for clinical remission at 6 and 12 months, including complete and partial remission, changes in kidney function and protein levels, and immunological response. Safety will be assessed over an extended period up to 84 months, tracking serious adverse events and treatment adaptations. The trial also examines the development of anti-drug antibodies and uses machine learning to refine the treatment model. Overall, participants will undergo laboratory tests, antibody monitoring, and clinical evaluations to measure the effectiveness and safety of the personalized rituximab regimen.

Personalized Rituximab Treatment Based on Artificial Intelligence in Membranous Nephropathy (iRITUX)