NCT03493685

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

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: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 371 (actual)
• Sponsor: Travere Therapeutics, Inc. · Industry
• Sex: All
• Age: 8 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Focal Segmental Glomerulosclerosis

Interventions

Type	Name	Description
DRUG	sparsentan	Double-blind period: target dose of 800 mg daily; Open-label extension: target dose based on dosage from week 114 daily
DRUG	Irbesartan	target dose of 300 mg daily

Timeline

• Start date: 2018-04-17
• Primary completion: 2023-03-20
• Completion: 2026-03-19
• First posted: 2018-04-10
• Last updated: 2026-04-17
• Results posted: 2024-04-30

Locations

226 sites across 22 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Croatia, Czechia, Denmark, Estonia, France, Germany, Hong Kong, Italy, New Zealand, Poland, Portugal, South Korea, Spain, Sweden, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study