A Pivotal Phase 3 Study of the Efficacy and Safety of DMX-200 in Patients With focal segmental glomerulosclerosis (FSGS) Who Are Receiving an angiotensin II receptor blocker (ARB)

Focal segmental glomerulosclerosis (FSGS) is a serious kidney disease where parts of the kidney's filtering units become scarred, causing significant protein to leak into the urine and, over time, kidney function to decline. It is a leading cause of kidney failure requiring dialysis or transplant. Currently there are limited effective treatments. This Phase 3 trial is testing a new oral medication called DMX-200 in adults and adolescents with FSGS. DMX-200 is taken twice daily alongside an existing blood pressure and kidney-protective medication called an angiotensin II receptor blocker (ARB). Participants are randomly assigned to receive either DMX-200 or a placebo for up to 104 weeks (about two years), with a possible two-year extension. The main goal is to see whether DMX-200 reduces the amount of protein in the urine — a key indicator of kidney damage — compared to placebo. You may be eligible if you are aged 12–80, have a confirmed kidney biopsy diagnosis of primary or genetic FSGS, are already taking or willing to start an ARB medication, and have significant proteinuria (protein in urine). People with secondary FSGS, active cancer, heart failure, or who are on immunosuppressive therapies are not eligible. This is one of the few trials offering a potential new treatment pathway for FSGS, a condition with very few effective options.