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

NCT05183646 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2026-02-03

No results posted yet for this study

Summary

DMX-200 (repagermanium) is a C-C chemokine receptor type 2 (CCR2) inhibitor that, when administered concurrently with an ARB, is designed to inhibit recruitment of monocytes implicated in the inflammatory chemokine environment of chronic disease. The purpose of this pivotal randomized double-blind study is to investigate the efficacy and safety of DMX-200 120 mg twice daily (BID) compared with placebo over a treatment period of 104 weeks in adult patients with FSGS who are being treated with an ARB. Given the rarity of the disease and the similarities between adults and pediatric patients with FSGS, Dimerix will also investigate the efficacy and safety of DMX 200 in adolescents aged 12 to 17 years. The double-blind period will be followed by an open-label extension (OLE) which aims to assess the long-term efficacy and safety of DMX 200 for up to 2 additional years.

Conditions

  • FSGS

Interventions

DRUG

DMX-200

DMX-200 (repagermanium) is a C-C chemokine receptor type 2 (CCR2) inhibitor.

DRUG

Placebo

Patients will receive 120 mg capsules of Placebo twice daily

Sponsors & Collaborators

  • Dimerix Bioscience Pty Ltd

    lead INDUSTRY

Principal Investigators

  • David Fuller · Dimerix Bioscience Pty Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-30
Primary Completion
2029-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • China
  • Czechia
  • Denmark
  • France
  • Germany
  • Hong Kong
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • New Zealand
  • Portugal
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05183646 on ClinicalTrials.gov