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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 FSGS

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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 FSGS

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 01 Aug 2024

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At a glance

  • Drugs Sparsentan (Primary) ; Irbesartan
  • Indications Focal segmental glomerulosclerosis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms DUPLEX
  • Sponsors Travere Therapeutics

    • Most Recent Events

    • 14 May 2024 According to a Travere Therapeutics media release, company announced that they will present abstracts in rare kidney disease at the National Kidney Foundation (NKF) Spring Clinical Meetings in Long Beach, California, May 14 to 18, 2024
    • 06 May 2024 According to a Travere Therapeutics media release, company continue to review the data from this DUPLEX Study and engage with the nephrology community to facilitate our planned engagement with FDA on potential regulatory pathways for sparsentan in FSGS.
    • 04 Dec 2023 According to a Travere Therapeutics media release, the Company has completed its planned Type C meeting with the FDA to discuss previously reported results from the Phase 3 DUPLEX Study of sparsentan in FSGS. The FDA communicated that the Phase 3 DUPLEX Study results alone are not sufficient to support an sNDA submission. The Company plans to re-engage with the FDA later in 2024.

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