RecruitingPHASE3INTERVENTIONAL

A Study of the Efficacy and Safety of DMX-200 in Patients With FSGS Who Are Receiving an ARB

This study is testing a new medication called DMX-200 for people aged 12 to 80 who have a kidney disease called Focal Segmental Glomerulosclerosis (FSGS). FSGS can cause serious kidney damage. DMX-200 is designed to work alongside an existing treatment called an ARB to help protect the kidneys. The study will compare DMX-200 with a dummy pill (placebo) to see if it's safe and effective. Participants will take the study medicine for about two years, followed by a chance to continue on DMX-200 for a longer period. This research aims to find new ways to treat FSGS and improve kidney health.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Dimerix Bioscience Pty Ltd

Enrolment target

286

Start

30 May 2022

Estimated completion

01 Dec 2029

FSGS

What is this study about?

This research study is looking into a new medication called DMX-200 for people living with Focal Segmental Glomerulosclerosis, often shortened to FSGS. FSGS is a serious condition that harms the tiny filters in your kidneys, which can lead to kidney damage over time. Currently, doctors use medicines like ARBs to help, but there's a need for more effective treatments. DMX-200 is designed to prevent certain cells from causing inflammation and damage in the kidneys, working alongside your current ARB medication.

The main goal of this study is to find out if DMX-200 is safe and whether it can help protect the kidneys of people with FSGS. Scientists want to see if it's better than a dummy pill (called a placebo) at slowing down the disease. They will be carefully watching to see how DMX-200 affects your kidney function and whether it causes any unwanted side effects. The study involves both adults and teenagers with FSGS because the disease can affect these age groups in a similar way.

Taking part would mean you'd be among the first to try this new treatment approach. Your participation could help doctors better understand FSGS and potentially lead to a new treatment option for many people in the future. This kind of research is vital for advancing medical care and improving the lives of those affected by serious conditions like FSGS.

Key takeaways

This study is testing a new drug for people with the kidney condition FSGS.
It aims to see if DMX-200, alongside an ARB medicine, is safe and effective.
Both adults and teenagers (12-80 years old) with FSGS may be able to join.
Participants will receive either DMX-200 or a placebo for about two years.
Joining could help find better treatments for FSGS for future patients.

Who may be eligible?

This study is looking for people aged between 12 and 80 years old who have been diagnosed with FSGS. Your FSGS diagnosis needs to have been confirmed by a kidney biopsy within the last seven years. You must also be taking a specific type of blood pressure medicine called an ARB, or be willing to start taking one.

There are also some important checks about your kidney function and blood pressure – your doctor will be able to explain these in detail. If you are taking certain other medications for your kidneys or blood pressure, their doses need to have been stable for a set period before you can join the study. If you're a woman who could become pregnant, you'll need to agree to use effective contraception during the study. Similarly, men with female partners who could become pregnant will also need to use contraception.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 12 and 80 years old?
Do you have a confirmed diagnosis of FSGS from a kidney biopsy in the last 7 years?
Are you currently taking an ARB medicine, or willing to start one?
If you're a woman who could get pregnant, are you willing to use effective birth control?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study starts with a screening period of about 6 to 14 weeks to check if you're suitable. Once confirmed, you'll take the study medication (either DMX-200 or a placebo) twice a day for about two years. During this time, you'll have regular visits to the clinic for check-ups, blood tests, urine tests, and to monitor your overall health and kidney function. After the main two-year period, there's an option to continue taking DMX-200 in an 'open-label' extension for up to an additional two years, meaning everyone will receive DMX-200 during this phase. There will also be a short follow-up period after you stop taking the study medication. In total, your involvement in the study could last for about four and a half years.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as gaining access to a new experimental treatment for FSGS that isn't yet widely available. You'll also receive careful monitoring of your health by a dedicated medical team. However, there are potential risks, as DMX-200 is an investigational drug, and its full range of side effects is not yet known. Some people might experience side effects from the medication. There is also no guarantee that DMX-200 will be effective for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (220)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Alabama at Birmingham
Verified postcode
Birmingham, United States· Active not recruiting
Phoenix Children's Hospital
Verified postcode
Phoenix, United States· Recruiting
Arizona Kidney Disease and Hypertension Center
Verified postcode
Phoenix, United States· Active not recruiting
Loma Linda University Medical Center
Verified postcode
Loma Linda, United States· Active not recruiting
Cedars-Sinai Medical Center
Verified postcode
Los Angeles, United States· Recruiting
University of California, Los Angeles
Verified postcode
Los Angeles, United States· Recruiting
Amicis Research Centre
Verified postcode
Northridge, United States· Active not recruiting
Northridge Clinical Research Inc.
Verified postcode
Northridge, United States· Active not recruiting
Kaiser Permanente
Verified postcode
Oakland, United States· Recruiting
University of California Davis Health System
Verified postcode
Sacramento, United States· Recruiting
Scripps Health
Verified postcode
San Diego, United States· Active not recruiting
Stanford Hospital and Clinic
Verified postcode
Stanford, United States· Recruiting

Common questions

What is FSGS?

FSGS stands for Focal Segmental Glomerulosclerosis, which is a kidney disease that damages the tiny filters in your kidneys.

What is an ARB?

An ARB is a type of medicine, often used to treat high blood pressure and protect kidneys, especially in conditions like FSGS.

What does 'double-blind' mean?

Double-blind means that neither you nor your study doctor will know if you are receiving the new drug (DMX-200) or a dummy pill (placebo).

Will I get the actual drug if I join?

During the main part of the study, you have a chance of getting either the new drug (DMX-200) or a placebo (dummy pill). Later, in the 'open-label' part, everyone receives DMX-200.

How long will I be involved?

Your involvement could last up to four and a half years, including initial checks, about two years on the main treatment, and an optional two more years for an extended treatment.

How to find out more

David Fuller

action3@dimerix.com +61 1300 813 321 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.