Novartis (NYSE: NVS) announced results from its ALIGN Phase III trial showing that Vanrafia (atrasentan) slowed kidney function decline compared to placebo in adults with IgA nephropathy over 2.5 years.

The trial measured estimated glomerular filtration rate (eGFR) changes, with Vanrafia showing an annualized eGFR slope of -2.7 mL/min/1.73 m²/year compared to -4.1 for placebo, representing approximately 34% slower decline. At the end of treatment at week 132, eGFR change from baseline was -6.9 for Vanrafia versus -9.5 for placebo.

The study also demonstrated sustained reductions in protein levels in urine. At 9 months, urine protein-to-creatinine ratio decreased 39.5% with Vanrafia compared to 1.9% with placebo. At end of treatment, the reduction was 28.8% versus 0.6% respectively.

In a subset of patients taking SGLT2 inhibitors alongside the study drug, eGFR change at study end was -1.5 with Vanrafia compared to -10.6 with placebo.

The results were published in The Lancet and presented at the European Renal Association Congress. Safety profiles remained consistent with previous studies, with adverse events similar to placebo and no new safety signals observed.

Vanrafia received accelerated approval in the United States and China in 2025 for reducing proteinuria in adults with IgA nephropathy. Novartis stated it plans to use the trial data to support submission for traditional approval in 2026.

IgA nephropathy is a kidney disease that can progress to kidney failure. The information is based on a company press release.