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A Pivotal Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of DMX-200 in Patients With Focal Segmental Glomerulosclerosis (FSGS) Who Are Receiving an Angiotensin II Receptor Blocker (ARB)

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A Pivotal Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of DMX-200 in Patients With Focal Segmental Glomerulosclerosis (FSGS) Who Are Receiving an Angiotensin II Receptor Blocker (ARB)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Nov 2023

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At a glance

  • Drugs Irbesartan/propagermanium (Primary)
  • Indications Focal segmental glomerulosclerosis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ACTION3
  • Sponsors Dimerix Bioscience

    • Most Recent Events

    • 24 Oct 2023 The protocol of this study has been amended as Safety and tolerability endpoint has been added and Trial focus has been shifted to Tu and AR, Inclusion age criteria has been changed from 18-80 to 12-80, hence children and adolescents are now being reenrolled in this study.
    • 20 Dec 2022 According to a Dimerix Bioscience media release, with Part 1 recruited, the trial will continue to recruit and randomise a further 72 patients at all activated clinical sites for Part 2 of the trial effective immediately, to reach a total of 144 patients for the second potential.
    • 20 Dec 2022 According to a Dimerix Bioscience media release, part 1 of the trial will conclude after the first interim analysis, once 72 patients have completed 35 weeks of treatment, and is expected to occur in the latter half of 2023. This trial is recruiting across over 70 sites in 11 different countries.

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