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)
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
- 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.