Novartis has announced final results from the Phase III ALIGN study, demonstrating that Vanrafia® (atrasentan) can slow the decline of kidney function in adults with IgA nephropathy (IgAN).
The study showed a 2.39 ml/min/1.73 m² difference in estimated glomerular filtration rate (eGFR) change from baseline compared with placebo at Week 136, four weeks after treatment ended.
Clinically meaningful improvements were observed at multiple timepoints, including Week 132, particularly in patients receiving additional treatment with sodium-glucose co-transporter-2 (SGLT2) inhibitors. At Week 132, the eGFR change from baseline versus placebo was 2.59 ml/min/1.73 m².
Vanrafia received accelerated approval in the U.S. and China in 2025 for the reduction of proteinuria in adults with IgAN. Novartis plans to submit for traditional regulatory approval in 2026. The ALIGN study offers the longest follow-up period among pivotal Phase III trials for IgAN, and the safety profile of Vanrafia remained consistent with previous findings.
IgA nephropathy is a progressive autoimmune kidney disease affecting approximately 25 people per million annually worldwide. The condition causes glomerular inflammation, proteinuria, and a gradual decline in eGFR. Up to half of patients with persistent proteinuria progress to kidney failure within 10 to 20 years, often requiring dialysis or kidney transplantation. Current supportive treatments do not address the underlying disease mechanisms, highlighting the need for more targeted therapies.
Alongside Vanrafia, Novartis is advancing a multi-asset portfolio for IgAN, including Fabhalta® (iptacopan) and investigational compound zigakibart.
