Medical-AI trial: personalizing rituximab dosing with AI — optimizing treatment in membranous nephropathy (a leading cause of nephrotic syndrome) (NCT06341205)

Membranous nephropathy is an autoimmune disease in which the kidney filter (the glomerulus) is attacked by the immune system and large amounts of protein leak into the urine; it is the most common cause of nephrotic syndrome in non-diabetic Caucasian adults. Its course varies greatly from person to person, from spontaneous remission to progression to chronic kidney disease.

In recent years, discovery of the autoantibody PLA2R1 supported a targeted approach, making rituximab, which depletes B cells, a safe and effective first-line drug. Yet a challenge remains: up to 40% of patients do not respond to a first course.

This interventional study examines whether the use of rituximab can be personalized with AI. Per the registry summary, taking into account each patient differing condition (in the nephrotic state, drug handling also changes), it aims to optimize dosing with an AI-based personalized protocol. The primary outcome is clinical remission (complete or partial) six months after starting rituximab. The size is 120, and it is recruiting.

That the same drug works for some and not others owes much to differences in body size, drug metabolism, and disease state. In the nephrotic state, pharmacokinetics are easily disturbed (for example, drug lost into the urine), so a one-size dose is hard to optimize. Personalizing dosing with AI points toward precision medicine, using potent, expensive biologics at the effective dose and timing.

That said, this study evaluates a personalized protocol; it does not recommend an established treatment.