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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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Trial Profile

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: 08 May 2025

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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

  • 30 Apr 2025 According to a Dimerix Bioscience media release, The enrollment completion in this study is expected by end of this year,Also the company successfully aligned Type C meeting with FDA on proteinuria as an appropriate primary endpoint for traditional marketing approval for DMX-200 in March 2025.
  • 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.

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