#USA #San Diego #IgA nephropathy #CSL Vifor #Travere Therapeutics

CSL Vifor and Travere Therapeutics Endorse Updated KDIGO Guidelines

On September 26, 2025, CSL Vifor and Travere Therapeutics officially recognized the updated Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guidelines concerning IgA Nephropathy (IgAN). This update delineates essential diagnostic criteria and outlines comprehensive treatment goals, primarily aimed at addressing the treatment challenges faced by individuals afflicted with this obscure yet impactful kidney condition.

Understanding IgA Nephropathy

IgA Nephropathy, often referred to as Berger's disease, is characterized by the accumulation of immunoglobulin A (IgA) in the kidneys, leading to a gradual decline in kidney function. Symptoms can vary widely, including hematuria (blood in urine), proteinuria (protein in urine), edema, and hypertension. As the condition progresses, it increases the risk of kidney failure, underscoring the need for effective therapeutic options.

Highlights from the Updated Guidelines

The newly released guidelines establish remission of proteinuria (defined as less than 0.5 g/day, ideally under 0.3 g/day) and the mitigation of estimated Glomerular Filtration Rate (eGFR) decline as primary treatment goals. CSL Vifor and Travere Therapeutics emphasize that achieving these benchmarks can significantly improve patient outcomes regarding kidney health.

A pivotal component of the guidelines is the endorsement of FILSPARI® (sparsentan), the first Dual Endothelin Angiotensin Receptor Antagonist (DEARA) specifically indicated for managing IgAN. The guidelines recognize FILSPARI's unique position as the only treatment with demonstrated superiority over traditional Renin-Angiotensin System inhibitors (RASi) in previous clinical trials. Notably, the PROTECT trial, the largest interventional study dedicated to IgAN, involved 404 participants and showed that patients on FILSPARI experienced a 49.8% reduction in proteinuria compared to only 15.1% in those treated with irbesartan, another RASi.

According to Professor Dr. med. Jürgen Floege, a senior nephrology expert from RWTH Aachen University in Germany, the updated KDIGO guidance is a significant achievement for the IgAN community. It enhances treatment clarity and builds confidence among healthcare providers as they navigate therapeutic decisions, ultimately aiming to secure better long-term kidney health for patients.

Filspare's Role in Treatment

The updated KDIGO guidelines underscore FILSPARI’s role as an essential first-line treatment option for patients at risk of progressive kidney function loss due to IgAN. Dr. Achim Obergfell, Global Medical Head for CSL Vifor’s nephrology portfolio, commented on the importance of these guidelines, stating that the inclusion of FILSPARI not only validates its efficacy but also reinforces its favorable safety profile, ensuring that patients can minimize their protein levels while maintaining an acceptable quality of life.

Dr. Jula Inrig, Chief Medical Officer of Travere Therapeutics, echoes this sentiment, describing the guidelines as a monumental step forward, reflecting advancements in understanding IgAN and reinforcing clearer pathways for patient management.

Conclusion

The publication of the KDIGO clinical practice guidelines serves as a definitive resource for medical professionals involved in the diagnosis and treatment of IgA Nephropathy. These guidelines provide an evidence-based approach to therapeutics, ensuring that patients receive the best possible care. Both CSL Vifor and Travere Therapeutics are committed to supporting healthcare providers and patients navigating their journey through this complex disease, hopeful for improved outcomes in the near future.

FILSPARI is currently approved for use in the United States and several European markets, including Germany, Austria, Switzerland, Luxembourg, and the UK, ensuring that patients across these regions now have access to a groundbreaking treatment option for IgAN.