Novartis announced final results from the Phase III ALIGN study, showing that Vanrafia (atrasentan) slows the decline in kidney function compared with placebo in adults with IgA nephropathy (IgAN).
The results of the study, conducted over 2.5 years, were published in The Lancet magazine , and the case report was presented at the European Association of Nephrology (ERA) Congress.
The randomised, multicentre, double-blind study enrolled 340 patients with biopsy-proven IgAN and assessed the safety, tolerability and efficacy of Vanrafia compared with placebo for 132 weeks.
The data obtained provided concrete evidence of the effect of vanrafia on estimated glomerular filtration rate (eGFR) and reduction of urinary protein.
The change in estimated glomerular filtration rate (eGFR) from baseline to the end of treatment (week 132) showed a decrease of -6.9 mL/min/1.73 m² for Vanrafia compared with -9.5 mL/min/1.73 m² for placebo.
These results correspond to a reduction in blood flow rate of 2.6 ml/min/1.73 m² in the treatment group.
The annual rate of decline in SCF from week 0 to week 136 was -2.7 for Vanrafia compared with -4.1 for placebo, indicating a 1.4-fold slowing of decline, corresponding to approximately 34% slowing of deterioration.
In addition, a relative reduction in urinary protein to creatinine ratio was demonstrated by 38.3% after nine months (week 36) and by 28.4% by the end of treatment.
In the sodium-glucose cotransporter-2 (SGLT2) inhibitor group, Vanrafia resulted in a change from baseline in estimated glomerular filtration rate (eGFR) of -1.5, compared with -10.6 in the placebo group at the end of the study (week 136), a difference of 9.1.
These effects were similar across different measures of kidney function both in the main study and in those who received additional SGLT2 inhibitors.
Ruchira Glaser, Global Head of Cardiovascular, Renal and Metabolic Diseases at Novartis, said: «ALIGN validates Vanrafia’s potential as a foundational therapy for IgAN and our commitment to delivering long-term kidney protection through continuous innovation.
«Together with our broader product portfolio, these data strengthen confidence in a science-based approach to treating this progressive disease.».
The safety profile remained unchanged, and adverse events were similar to those with placebo.
Vanrafia received accelerated approval in China and the United States in 2025 for reducing proteinuria in adults with IgAN. Novartis will use these results to support its application for traditional approval in 2026.
Earlier this year, Novartis announced that it had achieved the primary endpoint in its pivotal Phase III RemIND clinical trial evaluating the efficacy of oral remibrutinib in chronic induced urticaria.
The article "Novartis Reports Positive Results from Phase III Clinical Trial of ALIGN for IgAN" was originally created and published by Clinical Trials Arena, a brand owned by GlobalData.
The information on this website is provided in good faith and is for general informational purposes only. It is not intended to constitute advice on which you should rely, and we make no representations, warranties, or promises, express or implied, regarding its accuracy or completeness. Before making or refraining from making any decisions based on the information provided on our website, you should seek professional or specialized advice.