NCT01613118

Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis

Efficacy and Safety of Sparsentan (RE-021), a Dual Endothelin Receptor and Angiotensin Receptor Blocker, in Patients With Focal Segmental Glomerulosclerosis (FSGS): a Randomized, Double-Blind, Active-Control, Dose-Escalation Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Travere Therapeutics, Inc. · Industry
• Sex: All
• Age: 8 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate whether RE-021 (Sparsentan), a selective dual-acting receptor antagonist with affinity for endothelin (A type) and angiotensin II receptors (Type 1), is safe and effective in treating patients with focal segmental glomerulosclerosis (FSGS).

Detailed description

Focal segmental glomerulosclerosis (FSGS) is a rare glomerular disorder which results in frank proteinuria and in some patients progression to end-stage kidney disease (ESKD) over 5-10 years. Proteinuria reduction is widely regarded to be beneficial and is considered the primary goal of treatment in FSGS and slowing its progressive course (D'Agati, et. al, 2011). Patients are currently treated with angiotensin receptor blockers (ARB) and angiotensin converting inhibitors (ACEI) to lower proteinuria with steroids, calcineurin inhibitors, and other immunosuppressive agents reserved for patients with severe proteinuria and in particular with nephrotic syndrome. Despite these therapies, many patients have nephrotic range proteinuria and new therapeutic agents are needed. Endothelin receptor antagonists (ERA) have been shown to lower proteinuria in clinical trials of diabetic nephropathy and have been speculated to be effective in FSGS.

Conditions

• Focal Segmental Glomerulosclerosis

Interventions

Type	Name	Description
DRUG	RE-021 (Sparsentan)	Oral, once-daily
DRUG	Irbesartan	Oral, once-daily

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-06-01
• Completion: 2024-03-25
• First posted: 2012-06-06
• Last updated: 2025-05-15
• Results posted: 2021-07-27

Locations

33 sites across 3 countries: United States, Czechia, Italy