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: 06 Dec 2023
Price :
$35
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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
- 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.
- 03 Nov 2023 Results of efficacy and safety of longer-term treatment with sparsentan , published in the New England Journal of Medicine
- 03 Nov 2023 According to a Travere Therapeutics media release, results from this trial were published in the New England Journal of Medicine.