St. Gallen, Switzerland & San Diego, CA – CSL Vifor and Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced their support for the newly published Kidney Disease: Improving Global Outcomes (KDIGO) 2025 Clinical Practice Guideline for the management of IgA Nephropathy (IgAN) and IgA Vasculitis.
The updated recommendations redefine treatment goals and approaches for IgAN, with proteinuria remission (<0.5 g/day, ideally <0.3 g/day) and slowing eGFR decline set as key targets.
FILSPARI® Recognized in Updated Guidelines
- FILSPARI® (sparsentan), the first dual endothelin angiotensin receptor antagonist (DEARA), is highlighted as a potential first-line therapy for managing IgAN-driven nephron loss.
- FILSPARI is the only therapy with proven efficacy over optimized RASi in a Phase 3 head-to-head trial (PROTECT).
- The PROTECT trial enrolled more patients than all prior RASi IgAN studies combined.
Expert Perspectives
“The updated KDIGO guidance provides greater clarity and confidence for clinicians, ultimately aiming to improve long-term kidney outcomes.”
- Prof. Jürgen Floege, University Hospital RWTH Aachen.
“Inclusion of FILSPARI underscores its clinical benefit in reducing proteinuria and slowing kidney function decline.”
- Dr. Achim Obergfell, Global Medical Head Nephrology, CSL Vifor.
“This milestone reflects advances in understanding IgAN and validates FILSPARI as a foundational treatment.”
- Dr. Jula Inrig, CMO, Travere Therapeutics.
About the PROTECT Study
- Design: Phase 3, global, randomized, head-to-head trial of FILSPARI (400 mg) vs. irbesartan (300 mg) in 404 IgAN patients.
- Primary results (Week 36): FILSPARI achieved a 49.8% mean reduction in proteinuria vs. 15.1% with irbesartan (p<0.0001).
- Final results (Week 110): FILSPARI slowed kidney function decline compared with irbesartan.
- Safety: Adverse events were balanced between arms; dizziness and hypotension more frequent with FILSPARI.
About IgA Nephropathy
- IgAN is a rare progressive kidney disease and a leading cause of kidney failure worldwide.
- Estimated to affect >250,000 people across licensed territories.
- Symptoms include hematuria, proteinuria, high blood pressure, and progressive loss of kidney function.
About FILSPARI® (sparsentan)
- Class: Non-immunosuppressive DEARA with dual selectivity for ETAR and AT1R.
- Status: Approved for IgAN in the U.S. and Europe; launched in the U.S., Germany, Austria, Switzerland, Luxembourg, and the UK.
- Designation: Orphan Drug status in U.S., EU, and UK.
- Rights: Developed by Travere; CSL Vifor holds exclusive commercialization rights in Europe, Australia, New Zealand, and select territories.
About CSL Vifor
Global partner of choice in iron deficiency and nephrology, headquartered in St. Gallen, Switzerland, with 29,000+ employees worldwide. More: CSL.com
About Travere Therapeutics
Biopharma company dedicated to rare diseases, headquartered in San Diego, CA. More: travere.co
