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Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS) — DUPLEX  

Focal Segmental Glomerulosclerosis Clinical Trial

Official title:
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

Clinical Trial Summary

To determine the long-term nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with primary and genetic focal segmental glomerulosclerosis (FSGS).

Clinical Trial Description

This is a randomized, multicenter, double-blind, parallel, active-control study. Approximately 300 patients aged 8 to 75 years (inclusive) will be enrolled in the study. The study will be conducted in approximately 300 study centers, globally. The investigational drug (sparsentan) is a dual-acting angiotensin receptor blocker and endothelin receptor antagonist. The active control is irbesartan. Patients who meet eligibility criteria will require washout from renin-angiotensin-aldosterone system (RAAS) blockers, if applicable prior to their first dose of study drug. Patients will be randomly assigned in a 1:1 ratio to receive either sparsentan or active control (irbesartan). After completing the double-blind portion of the study, patients may participate in the open-label extension for treatment with sparsentan if they meet eligibility criteria. Primary completion date represents the anticipated completion date of the double-blind portion of the study. Study completion date represents the anticipated completion date of the open-label extension portion of the study. ;

Study Design

Related Conditions & MeSH terms

  • Focal Segmental Glomerulosclerosis
  • Glomerulosclerosis, Focal Segmental
Clinical Trial Details
NCT number NCT03493685
Study type Interventional
Source Travere Therapeutics, Inc.
Contact
Status Active, not recruiting
Phase Phase 3
Start date April 17, 2018
Completion date February 2026
View Details
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