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Abstract: INFO16-SA

ACTION3 Pivotal Phase 3 Clinical Trial and Open-Label Extension Study Assessing the Efficacy and Safety of DMX-200 (Repagermanium) in Adult and Paediatric Patients with FSGS

Session Information

  • Informational Posters - III
    November 04, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: Glomerular Diseases

  • No subcategory defined

Authors

  • Soman, Ashish, Dimerix Bioscience Pty Ltd, Melbourne, Victoria, Australia
  • Smith, Alisha J., Dimerix Bioscience Pty Ltd, Melbourne, Victoria, Australia
  • Shepherd, Robert, Dimerix Bioscience Pty Ltd, Melbourne, Victoria, Australia
  • Webster, Nina, Dimerix Bioscience Pty Ltd, Melbourne, Victoria, Australia
Description

DMX-200 (repagermanium) is a C-C chemokine receptor type 2 (CCR2) inhibitor administered with an angiotensin II receptor blocker (ARB) to inhibit monocytes recruitment implicated in the inflammatory environment of chronic kidney disease.
The AT1R and CCR2 Targets for Inflammatory Nephrosis (ACTION3) Phase 3 randomized double-blind placebo-controlled study will investigate the efficacy and safety of DMX-200 120 mg BID compared with placebo over a treatment period of 104 weeks in 286 patients with FSGS who are being treated with a stable dose of an ARB.
The study is recruiting patients at sites in Argentina, Australia, Brazil, Denmark, France, HK, NZ, Spain, Taiwan, UK, and USA.
The primary objective is to evaluate the change in proteinuria and chronic eGFR slope in patients receiving DMX-200 compared to those receiving placebo. Secondary objectives include assessment of safety, tolerability and effect of treatment on worsening of kidney function.
The first blinded interim analysis (IA) will be performed by an independent committee after approximately 72 randomized patients complete 35 weeks of treatment. A second IA may be performed once 144 enrolled patients complete 35 weeks of treatment. The study protocol has been updated to include enrolment of paediatric patients and an open-label extension study for all patients.
Following preliminary PK modelling and consultation with regulators, the study will include adolescent patients aged 12 years and older at sites in the USA, UK, Mexico and Argentina. Adolescent patients begin recruitment following a scheduled review of adult PK during the first IA.
All patients completing the 104-week study period will be offered access to an open-label extension study of DMX-200 for an additional period of up to 2 years. This period begins 4-weeks after completion of the randomised period, and ensures patients have access to treatment during the regulatory submission and review periods.

Funding

  • Dimerix Bioscience Pty Ltd is sponsor of this study.