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A Study of DMX-200 for FSGS

This study is looking at DMX-200 (repagermanium) for people with FSGS (Focal Segmental Glomerulosclerosis), a kidney disease. DMX-200 works by blocking a protein called CCR2, which may help reduce inflammation in the kidneys. Participants will also be taking an ARB (Angiotensin Receptor Blocker), a common medication for kidney disease. Researchers want to see if DMX-200 can improve kidney function by measuring changes in urine protein and how well the kidneys filter waste (eGFR). They will also check for any side effects. The study is open to people aged 12 to 80 who have been diagnosed with FSGS and are taking an ARB. The study aims to enroll 286 participants, but its current status is unclear.

Study design
This is a Phase 3, multi-center, randomized, double-blind study. This means participants will be randomly assigned to receive either DMX-200 or a placebo, and neither you nor your doctor will know which you are receiving.
What's involved
The double-blind part of the study involves a screening period, a 104-week treatment period, and a 4-week follow-up. Some participants may then enter an open-label extension for at least another 104 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 4 weeks after the double-blind treatment period, and for 4 weeks after the open-label extension period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05183646

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

Recruiting
PHASE3Ages 12–80InterventionalTreatment
Dimerix Bioscience Pty Ltd
~286 participants
Updated 2026-02-03 on ClinicalTrials.gov
What's tested:DMX-200Placebo

At a glance

Recruiting sites
28 of 220 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate the efficacy of DMX-200 in terms of urine protein/creatinine ratio (PCR) in patients with FSGS who are receiving an ARB.
Measured over Baseline to Week 35
+2 more outcomes measured

Conditions

FSGS

Explore related trials

Focal Segmental Glomerulosclerosis

Where it's being run

220 sites across 62 states
China19
United Kingdom16
Spain11
Australia10
California9
Germany9
Portugal9
Argentina8

Study leadership

  • David Fuller · STUDY_DIRECTOR · Dimerix Bioscience Pty Ltd

Who to contact

David Fuller
[email protected]
+61 1300 813 321
Email the study team

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What this trial measures

  • Evaluate the efficacy of DMX-200 in terms of urine protein/creatinine ratio (PCR) in patients with FSGS who are receiving an ARB.Baseline to Week 35

    Percent change in urine PCR (based on 24-hour urine collection)

  • Evaluate the efficacy of DMX-200 in terms of estimated glomerular filtration rate (eGFR) slope in patients with FSGS who are receiving an ARB (Analysis at week 35 and Week 104).Baseline to Week 104

    Slope of eGFR

  • OLE - Assess the long-term safety and tolerability of open-label treatment with DMX-200 in patients with FSGS who are receiving an ARB.Double-blind baseline to Week 216

    Incidence and severity of treatment-related adverse events (AEs) and any adverse events of special interest (AESIs) and serious adverse events (SAEs) following long-term treatment with DMX-200.