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: 17 Apr 2018

At a glance

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

    • 03 Apr 2018 Data from the 36-week efficacy endpoint analysis is expected in the second half of 2020, according to a Retrophin media release.
    • 03 Apr 2018 According to a Retrophin media release, analysis of interim efficacy endpoint which is the proportion of patients achieving a modified partial remission of proteinuria (urine protein-to-creatinine ratio (Up/C) =1.5 g/g and a >40 percent reduction in Up/C from baseline) at Week 36, will serve as the basis for Subpart H accelerated approval of sparsentan in the US and Conditional Marketing Authorization (CMA) consideration in Europe.
    • 03 Apr 2018 Status changed from planning to recruiting, according to a Retrophin media release.
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