ACTION3 FSGS Study

What does the ACTION3 study involve?

The ACTION3 Study will examine if the investigational medicine, DMX-200 (repagermanium), reduces the amount of proteinuria (protein in your urine) and slows the decline of kidney function, when taken in addition to a medicine called an angiotensin II receptor blocker (ARB). An ARB is a very commonly used medicine in FSGS. ACTION3 will also investigate what side effects may occur.

The ACTION3 study will compare the investigational medication with a placebo. The placebo looks like the study drug but does not contain DMX-200. Both the investigational medication and placebo will be given as capsules that will need to be taken twice daily by mouth. You will be randomly assigned to either study drug or the placebo group. You have an equal chance (50%) to being in either group. Neither you nor the study team will know if you are receiving the study drug or the placebo.

This is a global study involving approximately 300 patients. The study will last up to 2 years and 3 months and will involve 13 study visits at which your doctor will assess your health and the effectiveness of DMX-200.Dimerix will also investigate the efficacy and safety of DMX-200 in adolescents aged 12 to 17 years. The study will be followed by an open-label extension (OLE) which aims to assess the long-term efficacy and safety of DMX-200 for up to 2 additional years

If you are a nephrologist with any potential patients or a patient interested in potential participation please visit our ACTION3 website at Action3fsgs.com for more information.