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Study on the Effectiveness and Safety of DMX-200 with Losartan in Adults with Focal Segmental Glomerulosclerosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a kidney disease called Focal Segmental Glomerulosclerosis (FSGS). FSGS is a condition that affects the kidney's filtering units, leading to scarring and potential kidney damage. The study is testing a treatment called DMX-200, which is a capsule containing the active substance Repagermanium. This treatment is being evaluated for its effectiveness and safety in patients who are already receiving a type of medication known as an Angiotensin II Receptor Blocker (ARB). ARBs are commonly used to manage high blood pressure and protect the kidneys.

The purpose of the study is to assess how well DMX-200 works in improving kidney function and its safety over time. Participants in the study will be randomly assigned to receive either DMX-200 or a placebo, which looks like the treatment but does not contain the active substance. The study will be conducted in a way that neither the participants nor the researchers know who is receiving the actual treatment or the placebo, ensuring unbiased results. The treatment period will last for several months, during which participants will have regular check-ups to monitor their kidney function and overall health.

In addition to DMX-200, the study involves several ARBs, including Losartan, Candesartan, Telmisartan, Irbesartan, Valsartan, Azilsartan Medoxomil, and Olmesartan Medoxomil. These medications are taken orally and are part of the standard treatment for managing FSGS. The study aims to provide valuable information on the potential benefits of adding DMX-200 to the existing treatment regimen for patients with FSGS.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, the patient will attend an initial visit. During this visit, the patient's medical history will be reviewed, and a physical examination will be conducted. Blood and urine samples will be collected to confirm eligibility for the trial.

  2. Step 2

    Randomization

    The patient will be randomly assigned to receive either the investigational medication DMX-200 or a placebo. This process is double-blind, meaning neither the patient nor the study team will know which treatment the patient is receiving.

  3. Step 3

    Treatment period

    The patient will take the assigned medication orally. The dosage and frequency will be determined by the study protocol. The treatment period will last up to 104 weeks, during which the patient will continue taking their current angiotensin II receptor blocker (ARB) medication.

  4. Step 4

    Regular follow-up visits

    Throughout the treatment period, the patient will attend regular follow-up visits. These visits will include physical examinations, blood and urine tests, and monitoring of any side effects. The patient's kidney function and protein levels in urine will be closely monitored.

  5. Step 5

    End of treatment visit

    At the end of the 104-week treatment period, the patient will have a final visit. This visit will include a comprehensive assessment of the patient's health, including blood and urine tests, to evaluate the effects of the treatment.

  6. Step 6

    Open-label extension

    After completing the double-blind period, the patient may be eligible to participate in an open-label extension. In this phase, all patients will receive DMX-200 to assess its long-term safety and tolerability.

Who can join the trial?

9 criteria

  • Must have been diagnosed with Focal Segmental Glomerulosclerosis (FSGS) within the last 7 years. This includes primary FSGS, genetic FSGS, or FSGS of unknown cause. A kidney biopsy is needed unless there is a known genetic mutation related to FSGS.
  • Must be taking an Angiotensin Receptor Blocker (ARB) at the highest dose you can tolerate, or be willing to switch to this treatment before the study starts. An ARB is a type of medication that helps control blood pressure.
  • If taking corticosteroids (a type of medication that reduces inflammation), the dose must be 10 mg or less per day and stable for at least 4 weeks before and during the study. Inhaled corticosteroids for breathing issues are allowed.
  • If taking other specific medications like aldosterone inhibitors, the dose must be stable for at least 12 weeks before the study and remain unchanged during the study.
  • Must have a urine protein/creatinine ratio greater than 1.5 g/g or a 24-hour total protein greater than 1.5 g/day during screening. This measures the amount of protein in your urine.
  • Must have an estimated glomerular filtration rate (eGFR) between 25 and 120 mL/min/1.73 m² for adults, or at least 25 mL/min/1.73 m² for adolescents. eGFR is a test to check how well your kidneys are working.
  • Must have a blood pressure of 160/100 mm Hg or lower for adults, or within the normal range for age, sex, and height for adolescents.
  • Must weigh at least 35 kg and have a body mass index (BMI) of 40 kg/m² or lower for adults, or within the normal range for age and sex for adolescents. BMI is a measure of body fat based on height and weight.
  • Must have completed participation in the previous part of the study, including the Week 104 visit.

Who cannot join the trial?

3 criteria

  • Patients who are not adults cannot participate. This means only individuals who are 18 years or older are eligible.
  • Patients who are not diagnosed with Focal Segmental Glomerulosclerosis (FSGS) cannot participate. FSGS is a condition that affects the kidneys.
  • Patients who are not receiving an ARB cannot participate. ARB stands for Angiotensin Receptor Blocker, which is a type of medication used to treat high blood pressure and kidney problems.
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Investigated drugs

DMX-200 is a medication being studied for its potential to help patients with a kidney condition called focal segmental glomerulosclerosis (FSGS). This condition can cause scarring in the kidneys, leading to problems with kidney function. DMX-200 is being tested to see if it can improve kidney health by reducing the amount of protein in the urine and slowing down the decline in kidney function. Patients in the study are also taking another type of medication called an angiotensin II receptor blocker (ARB), which is commonly used to help protect the kidneys.

What is already known about the treatment

DMX-200 – DMX-200 is administered orally and is currently being studied in a Phase 3 clinical trial for its effectiveness and safety in treating focal segmental glomerulosclerosis (FSGS), a kidney disorder. This medication is being tested in patients who are also receiving an angiotensin II receptor blocker (ARB), which is a type of blood pressure medication. The main goal of DMX-200 is to improve kidney function by reducing protein levels in urine and slowing down the decline in kidney filtration rate. It works by targeting specific pathways in the body that are involved in inflammation and fibrosis, which are processes that can damage the kidneys. DMX-200 is classified as an investigational drug, meaning it is still being studied and is not yet approved for general medical use.

Investigated diseases

Focal Segmental Glomerulosclerosis – Focal Segmental Glomerulosclerosis (FSGS) is a disease that affects the kidney's filtering units, known as glomeruli. It is characterized by scarring (sclerosis) in some of the glomeruli, which can lead to proteinuria, where protein is lost in the urine. Over time, this scarring can cause the kidneys to lose their ability to filter waste and excess fluid from the blood effectively. The disease can progress at varying rates, potentially leading to chronic kidney disease. FSGS can occur due to genetic factors, secondary to other conditions, or without a known cause. The progression of FSGS can result in a gradual decline in kidney function.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504597-37-00Protocol codeDMX-200-301Estimated enrolment356 patientsSponsorDimerix Bioscience Pty Limited

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