RecruitingPhase IIIInterventional

Efficacy and safety of DMX-200 in patients with focal segmental glomerulosclerosis

Focal segmental glomerulosclerosis (FSGS) is a kidney disease that scars the tiny filters inside your kidneys. When these filters are damaged, they become leaky and allow important proteins to escape from your blood into your urine. Over time, this can lead to kidney failure. Doctors usually treat FSGS with blood pressure tablets known as ARBs to help reduce kidney strain. This trial is investigating whether adding a new drug, DMX-200, can calm inflammation in the kidneys and provide better protection. The study is for people aged 12 to 80 with FSGS. Participants will take either DMX-200 or an inactive dummy pill (a placebo) alongside their standard medication for two years. Doctors will run regular blood and urine tests to monitor kidney health, check safety, and see if the new medicine helps keep kidneys working well for longer.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

Dimerix Bioscience Pty Ltd

Enrolment target

286

Start

23 Feb 2022

Estimated completion

31 Dec 2026

Focal segmental glomerulosclerosis

What is this study about?

Your kidneys contain millions of microscopic filters that clean your blood and remove waste. In focal segmental glomerulosclerosis (FSGS), some of these filters become inflamed and scarred. As a result, they begin to leak vital protein into your urine, which doctors call proteinuria. Over time, the kidneys struggle to do their job, which can eventually lead to kidney failure.

Standard treatment usually involves blood pressure medicines called ARBs (angiotensin II receptor blockers). While these medicines help, many people still experience worsening kidney damage. DMX-200 is an experimental medicine designed to block inflammation inside the kidney filters. Researchers hope that taking DMX-200 alongside an ARB will offer a more powerful shield against scarring than standard care alone.

This Phase III study aims to find out whether DMX-200 is both safe and effective at preserving kidney function over several years. If successful, this new combination could offer a valuable treatment option to help people with FSGS protect their kidneys and delay or prevent the need for dialysis or kidney transplants.

Key takeaways

The trial tests whether adding DMX-200 to standard treatment helps protect kidneys in people with FSGS.
It is open to people aged 12 to 80 who have protein leaking into their urine.
Participants have a 50/50 chance of receiving DMX-200 or a dummy pill (placebo) for two years.
You will need to attend regular clinic visits for blood, urine, and health checks.
Joining is completely voluntary, and you can withdraw at any time without affecting your standard care.

Who may be eligible?

This study is open to adults and young people aged between 12 and 80 who have been diagnosed with FSGS. In most cases, this diagnosis must have been confirmed by a kidney biopsy within the past seven years. However, a recent biopsy is not needed if you have a confirmed genetic mutation that causes FSGS.

To be eligible, your kidneys must still have a moderate level of function, and you must have high levels of protein showing up in your urine tests. You also need to be taking a stable, effective dose of an ARB blood pressure medicine, or be willing to switch over to one before the main study starts.

You might not be able to take part if you take high doses of steroids or if you have recently changed other specific kidney medicines. A doctor will check your overall health and review your current medications to confirm if joining the trial is safe for you.

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.

I am between 12 and 80 years old.
I have a confirmed diagnosis of FSGS (via biopsy or genetic test).
I have protein showing up in my urine tests.
I am currently taking an ARB medication or willing to switch to one.
My current steroid or kidney medication doses have been stable recently.

Answer every question to see your result.

What does participation involve?

Taking part begins with screening and preparation stages that last up to 14 weeks. During this time, the medical team checks your test results and ensures your standard kidney medicines are at the correct dose. The main part of the study lasts for two years (104 weeks). During this period, you have a 50/50 chance of receiving either DMX-200 or a placebo (a dummy pill that looks identical but contains no active medicine). Neither you nor your doctor will know which one you are taking. You will visit the clinic regularly for blood tests, urine tests, and health reviews. After the two years, there is a 4-week safety follow-up. You may then be invited to join an extension study for up to two additional years, where everyone receives the real DMX-200 medicine.

Potential risks and benefits

Taking part may help lower the amount of protein in your urine and protect your kidneys, though direct benefits cannot be guaranteed, particularly if you are given the placebo. However, the findings will help doctors understand how to better treat FSGS in the future. DMX-200 has been well tolerated in previous studies, but possible risks and side effects can include temporary changes in liver test results, feeling unusually tired, or a reduced appetite. Your health will be monitored very closely throughout the trial with regular tests. Taking part is completely voluntary, and you are free to leave the study at any time without your regular NHS care being affected.

Locations (4)

King's College Hospital
Approximate
London, England
Great Ormond Street Hospital for Children
Approximate
London, England
Nottingham City Hospital
City only
Nottingham, England
Royal Manchester Childrens Hospital
City only
Manchester, England

Common questions

What is a placebo and why is it used?

A placebo is a dummy pill that looks just like the real medicine but has no active ingredients. Comparing DMX-200 to a placebo helps scientists prove whether any improvements are truly caused by the new drug.

Will I have to stop taking my regular kidney medicines?

No. DMX-200 is designed to be taken alongside your regular ARB blood pressure medication. Your doctor will make sure your usual prescription is stable before you start.

How do I take DMX-200?

DMX-200 is taken by mouth as capsules or tablets, following the daily instructions provided by the study team.

What happens if my kidney condition gets worse during the trial?

Doctors will monitor your blood and urine tests at every visit. If your kidney health worsens, the study team will step in promptly and can change or stop your study treatment to keep you safe.

Do I have to pay to take part in this trial?

No. The trial medication, clinic visits, and all study tests are free of charge, and travel expenses to and from the hospital are typically reimbursed.

How to find out more

David Fuller

ACTION3@dimerix.com +61 (0)1300 813 321 Official trial record

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