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Currently Enrolling
Interventional

ACTION3

A pivotal Phase 3, multicenter, randomized, 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)

Brief Description

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) for 104 weeks.

Currently Enrolling
Interventional

ACTION3

A pivotal Phase 3, multicenter, randomized, 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)

Brief Description

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) for 104 weeks.

Trial is for people with

Primary FSGS or FSGS of undetermined cause confirmed through a kidney biopsy or documentation of genetic FSGS, diagnosed within 7 years of screening

Study Goal

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.

What is involved for the Patient?

This study is looking at how safe a potential new, investigational medication (DMX-200) is and whether it works for people with a rare kidney disease called focal segmental glomerulosclerosis (FSGS). If you take part, you will receive either the potential new medication or a placebo in combination with an ARB. You will be in the ACTION3 Study for up to
28 months (just under 2.5 years). You will visit the study center up to 13 times.
You may also have the option to join an extension period once you complete the first Study Treatment period. During the extension period, all patients will receive the potential new medication (no placebo) in combination with an ARB.

About the drug or intervention

The study drug DMX 200 is a medication designed to reduce the function of a protein called C-C chemokine receptor type 2 (CCR2). The CCR2 protein plays an important role in some inflammatory processes in the body. By reducing the function of CCR2, cells that would normally respond to inflammation within the kidneys are unable to do so.
You will have to take the study medication twice a day by mouth (oral), once in the morning and once in the evening (approximately 12 hours apart) for 2 years.

Webster, TX (Clear Lake Specialties)
Frequently Asked Questions

Nephrotic Syndrome is not a disease itself, but rather a group of signs and symptoms that result from damage in the part of the kidney that filters blood (glomeruli).

Common symptoms include:

  • Foamy urine (called proteinuria) caused by protein “spilling” into the urine
  • Severe swelling in parts of the body, most noticeably around the eyes, hands, feet, and abdomen (called edema)
  • Weight gain due to a buildup of extra fluid
  • Fatigue
  • Loss of appetite
  • Low levels of protein in the blood (hypoalbuminemia)
  • Higher than normal fat and cholesterol levels in the blood (hyperlipidemia)

Nephrotic Syndrome can typically be diagnosed with a urine test.

Nephrotic Syndrome can be “primary” or “secondary” in nature.

Diseases that affect only the kidneys are called primary causes of Nephrotic Syndrome. Doctors often call these diseases “idiopathic,” which means that they arise from an unknown cause. Some of these diseases include:

  • Minimal Change Disease (MCD) – most common in children
  • Focal Segmental Glomerulosclerosis (FSGS)
  • Membranous Nephropathy (MN) – most common in adults
  • IgA Nephropathy (IgAN)

Secondary Nephrotic Syndrome is caused by an underlying, systemic condition like diabetes, lupus, HIV, and others.

Clinical studies are any studies that involve people. There are two main types: observational and interventional. In an observational trial, researchers track health outcomes over time in groups of participants to look for patterns that help us better understand a disease. In an interventional trial, participants receive specific interventions, which can include new treatments or behavorial changes (e.g., diet changes). To learn more about clinical research, please visit the NephCure website.