ES 
EN 
Estudio intervencionista
un ensayo clínico en el que se utiliza un nuevo fármaco o dispositivo para medir un resultado específico.
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)
Breve descripción
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.
Médico del ensayo / Coordinador del estudio
Laura Lamas
Correo electrónico
Teléfono
Nombre del sitio
Horizon Research Group.
Patrocinador
Dimerix Bioscience Pty Ltd
Fármaco del estudio
DMX-200
Matrícula estimada
286
Fecha de finalización estimada
31 de julio de 2025
Estudio intervencionista
un ensayo clínico en el que se utiliza un nuevo fármaco o dispositivo para medir un resultado específico.
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)
Breve descripción
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.
La prueba es para personas con
Primary FSGS or FSGS of undetermined cause confirmed through a kidney biopsy or documentation of genetic FSGS, diagnosed within 7 years of screening
Objetivo del estudio
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.
¿Qué implica para el paciente?
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.
Sobre el medicamento o la intervención
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.
