Healthcare giant Novartis has announced that its Phase III ALIGN study shows Vanrafia (atrasentan) may slow kidney function decline in adults with IgA nephropathy (IgAN), a progressive autoimmune kidney disease.
The trial found that four weeks after treatment ended, patients taking Vanrafia had a 2.39 ml/min/1.73 m² improvement in eGFR versus placebo at Week 136. Clinically meaningful benefits were also seen at Week 132, particularly in patients taking sodium-glucose co-transporter-2 (SGLT2) inhibitors, with eGFR improving 2.59 ml/min/1.73 m² over placebo.
“Progressive and complex diseases such as IgAN present an urgent need for medicines that can target the different drivers of the disease. Vanrafia can be seamlessly integrated into patients’ existing treatment plans, with a consistent safety profile,” said Ruchira Glaser, Global Head, Cardiovascular, Renal & Metabolic Development Unit, Novartis.
“We are pleased with today’s Phase III ALIGN results, which add to the growing evidence of Vanrafia as a potential foundational therapy to slow kidney function decline.”
Vanrafia, a potent endothelin A receptor antagonist, received accelerated approval in the US and China in 2025 for reducing proteinuria in adults with IgAN. Novartis plans to seek traditional approval in 2026.
The ALIGN study represents the longest follow-up in pivotal Phase III IgAN trials, enrolling 340 patients with biopsy-confirmed disease. Participants received either once-daily Vanrafia or placebo alongside standard therapy, including renin-angiotensin system inhibitors, with some also receiving SGLT2 inhibitors.
Novartis emphasized that safety was consistent with previous findings, and highlighted its broader IgAN pipeline, including Fabhalta (iptacopan) and investigational zigakibart, as part of its commitment to kidney health.
IgAN affects approximately 25 per million people worldwide annually, and up to 50% of patients with persistent proteinuria progress to kidney failure within 10–20 years. Current treatments focus on supportive care, leaving a significant unmet need for therapies that address the root causes of disease.
