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: 17 Apr 2018
At a glance
- Drugs Irbesartan (Primary) ; Sparsentan (Primary)
- Indications Focal segmental glomerulosclerosis
- Focus Registrational; Therapeutic Use
- Acronyms DUPLEX
- Sponsors Retrophin
- 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.