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A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)

Trial Profile

A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Jan 2019

At a glance

  • Drugs Irbesartan (Primary) ; Sparsentan (Primary)
  • Indications Focal segmental glomerulosclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms DUPLEX
  • Sponsors Retrophin
  • Most Recent Events

    • 01 Nov 2018 According to a Retrophin media release, top-line data from the interim efficacy analysis are expected in the second half of 2020.
    • 05 Oct 2018 According to a Retrophin media release, the interim analysis of this study will be base for a New Drug Application (NDA) filing for Subpart H accelerated approval of sparsentan in the U.S. and Conditional Marketing Authorization (CMA) consideration in Europe.
    • 26 Jul 2018 According to a Retrophin media release, as per protocol 36 weeks efficacy interim endpoint unblinded analysis will be performed on at least 190 patients.
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