About
ACTION3 study

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. 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.

If the study is right for you and you choose to participate, all study-related care and study medication will be provided at no cost to you during your participation.

What is FSGS?

About Focal Segmental Glomerulosclerosis (FSGS)

FSGS is a progressive kidney disease for which there are no formally approved treatments. When you have FSGS, the filters (glomeruli) of your kidneys become inflamed and are damaged by scarring. This makes the filters “leaky” and allows protein from your blood to collect in your urine (proteinuria).

For patients with FSGS, the kidneys’ ability to purify (clean) the blood is impaired. This can eventually lead to kidney failure that may eventually requires dialysis or a kidney transplant.

 Find out more about FSGS here

Study Design

Screening and Qualification [ Min 10 weeks ] [ up to 14 weeks if transitioning to ARB ] Study Treatment period [ About 104 weeks, or 2 years ] Follow-up period [ up to 4 weeks ] Open Label Extension (OLE) [ up to 2 years ] for eligible participants

Test and assessments

What tests and assessments can I expect?

The following tests and assessments will occur at some or all of your study visits.

Demographics, and medical and medication history Physical examination Vital signs, weight, and height Electrocardiogram (ECG) Blood and urine tests, including 24-hour urine collection Pregnancy test Review of participant diary and questions

Are you eligible to participate?

You may be eligible to participate in the ACTION3 Study if:

Adults

18-80 years

Diagnosis

FSGS (Primary, Genetic, Undetermined cause excluding secondary)

Using an ARB or prepared to transition to an ARB

Study Locations

If you are interested in participating, please use to the map below to contact your closest participating site and request for more information on the ACTION3 Phase 3 FSGS study in kidney disease, sponsored by Dimerix.

Alternatively please contact your treating physician and request they contact Dimerix at [email protected].

For confidentiality purposes, we request patients do not contact Dimerix directly.

Find your nearest clinic
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Clinic Locations

Hospital Serdang Jalan Puchong, Kajang, Selangor, Malaysia. 43000 p | +60389475555 Hospital Kuala Lumpur Jalan Pahang, Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia. 50586 p | +60326155380 Hospital Raja Permaisuri Bainun Jalan Raja Ashman Shah, Ipoh, Perak, Malaysia. 30450 p | +60135201220 Pusat Perubatan Universiti Kebangsaan Malaysia Bandar Tun Razak, Cheras, Federal Territory of Kuala Lumpur, Malaysia. 56000 p | +60394156934 University Malaya Medical Centre Seksyen 13, Petaling Jaya, Federal Territory of Kuala Lumpur, Malaysia. 59100 p | +60379492497 Hospital Tengku Ampuan Afzan Kuantan, Pahang, Malaysia. 25100 p | +60139335007