Novartis has announced final results from the Phase III ALIGN study, highlighting that Vanrafia (atrasentan) slows kidney function decline versus placebo in adults with IgA nephropathy (IgAN).
The 2.5-year findings were published in The Lancet and showed a case at the European Renal Association (ERA) Congress.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The randomised, multi-centre, double-blind trial included 340 patients with biopsy-confirmed IgAN and evaluated the safety, tolerability, and efficacy of Vanrafia versus placebo over a period of 132 weeks.
The data provided specific evidence regarding Vanrafia’s impact on estimated glomerular filtration rate (eGFR) and urinary protein reduction.
The change from baseline in eGFR at the end of treatment (week 132) showed a decline of -6.9 mL/min/1.73m² for Vanrafia, compared to -9.5 mL/min/1.73m² for placebo.
These results correspond to a 2.6 mL/min/1.73m² slower decline in the treatment group.
The annualised eGFR slope from weeks zero to 136 was -2.7 for Vanrafia, compared to -4.1 for placebo, indicating a 1.4 times slower decline, which equates to a roughly 34% slower deterioration.
Additionally, a 38.3% relative reduction in the urine protein-to-creatinine ratio (UPCR) at nine months (week 36) was demonstrated, and a 28.4% reduction at the end of treatment.
In the sodium-glucose co-transporter-2 (SGLT2) inhibitor cohort, Vanrafia showed a change from baseline in eGFR of -1.5, compared to -10.6 with placebo at the end of the study (week 136), a difference of 9.1.
These effects were consistent across various measures of kidney function in the main study and in those additionally receiving SGLT2 inhibitors.
Novartis global cardiovascular, renal and metabolic development head Ruchira Glaser said: “ALIGN reinforces Vanrafia’s potential as a foundational IgAN therapy and our commitment to advancing long-term kidney protection through continued innovation.
“Together with our broader portfolio, these data strengthen confidence in an evidence-based approach to managing this progressive disease.”
Safety profiles remained unchanged, with adverse events similar to placebo.
Vanrafia received accelerated approval in China and the US in 2025 for reducing proteinuria in adults with IgAN. Novartis will use these results to support a submission for traditional approval in 2026.
Earlier this year, Novartis reported that its pivotal Phase III RemIND trial, evaluating oral remibrutinib in chronic inducible urticaria, achieved the primary endpoint.
