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CSL Vifor and Travere Therapeutics Support New Guidelines for IgA Nephropathy

In a significant development for the healthcare community, CSL Vifor and Travere Therapeutics have expressed their strong support for the recently published updated clinical practice guidelines for managing IgA Nephropathy (IgAN). Released by the Kidney Disease Improving Global Outcomes (KDIGO), these guidelines mark a pivotal moment in refining treatment approaches for patients suffering from this rare kidney disease.

Understanding IgA Nephropathy

IgA Nephropathy, often referred to as Berger's disease, is the most common form of primary glomerular disease worldwide. It is characterized by the abnormal accumulation of the immunoglobulin A (IgA) in the kidneys. This accumulation leads to various complications, including blood and protein in the urine and progressive loss of renal function. The impact of IgAN is profound, with over 250,000 individuals affected in licensed territories.

The New Guidelines

Published in September 2025, the updated KDIGO guidelines redefine the diagnostic criteria, treatment goals, and strategies for managing IgA Nephropathy. Central to these guidelines is the aim to achieve remission of proteinuria (less than 0.5 g/day, ideally below 0.3 g/day) and to slow the decline in estimated glomerular filtration rate (eGFR). These benchmarks serve as crucial objectives for both clinicians and patients.

The guidelines recommend employing treatment modalities that simultaneously target nephron loss and the formation of IgA as they work towards achieving these goals. Notably, the guidelines endorse the use of FILSPARI (sparsentan), a unique Dual Endothelin Angiotensin Receptor Antagonist (DEARA), as a potential first-line approach, diverging from the traditional RASi-first treatment pathway.

FILSPARI's Role

FILSPARI has been highlighted for its effectiveness based on clinical trial evidence, which eclipses that of optimized Renin-Angiotensin System inhibitors (RASi). The PROTECT Study stands out as one of the largest interventional trials to date for IgAN. This Phase 3 trial demonstrated notable outcomes, with a substantial reduction in proteinuria among those treated with FILSPARI compared to irbesartan. The trial's primary endpoint was convincingly met, showcasing FILSPARI's potential in the therapeutic landscape for this condition.

Expert Insights

Clinical experts have heralded the new guidelines as a landmark advancement for the IgA Nephropathy community. Prof. Dr. Jürgen Floege, a senior nephrology professor at RWTH Aachen University, stated, “The revised KDIGO guidance gives patients and healthcare providers enhanced clarity in treatment decision-making, ultimately striving for improved long-term kidney outcomes.”

Dr. Achim Obergfell, Global Medical Head of the Nephrology Portfolio at CSL Vifor, emphasized that FILSPARI’s inclusion in the guidelines underscores its efficacy and safety profile, advocating for its role in assisting eligible patients with proteinuria reduction.

Implications for Treatment

The newly released KDIGO guidelines are not merely a set of recommendations; they signify a comprehensive, evidence-based structure for healthcare professionals tasked with diagnosing and treating IgA Nephropathy and IgA vasculitis. The guidelines were officially presented during the International Symposium of IgA Nephropathy in September 2025 and will be available as a supplement to the Official Journal of the International Society for Nephrology.

Conclusion

With the endorsement of both CSL Vifor and Travere Therapeutics, the updated clinical practice guidelines for IgA Nephropathy promise a brighter future for patients battling this challenging condition. The focus on innovative therapies like FILSPARI, backed by robust clinical evidence, may significantly enhance patient care, reducing the burden of disease while striving for better health outcomes.