A pivotal Phase 3, multicentre, randomised; double- blind, placebo- controlled 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) (Action 3)

This is a clinical research study of a new medication called DMX-200 (repagermanium) for people with focal segmental glomerulosclerosis (FSGS). FSGS is a progressive kidney disease where the filters (glomeruli) of your kidneys become inflamed and are damaged by scarring. This makes the filters ‘leaky’ over time and allows protein from the blood to collect in the urine (proteinuria). In FSGS, the kidneys are not able to properly clean the blood, which may cause kidney failure. In severe cases, people with FSGS need renal replacement therapy such as dialysis or a kidney transplant. Treatments that reduce proteinuria are likely to improve the outlook of kidney function. A family of drugs called angiotensin II receptor blockers (ARB) work by reducing blood pressure and improving kidney function. The main purpose of this study is to see if DMX-200 (repagermanium) reduces proteinuria and slows the loss of kidney function when taken at the same time as an ARB. This period of the study will also look at tolerability and safety of the drug, how fast the study drug is broken down in the body by measuring the levels of study drug that enters the blood and how the study drug affects other measures of kidney function such as creatinine clearance (a test used to check kidney function). This is a Phase 3 study, which means that the drug has been previously tested in people and there is information about the benefit and risk of receiving this study drug. In all trials the study drug has generally been safe and well tolerated in the studies completed to date.