Novartis has announced final data from the Phase III ALIGN study, highlighting that Vanrafia (atrasentan) slowed kidney function decline in adults with immunoglobulin A nephropathy (IgAN).
The randomised, global, double-blind, placebo-controlled, multi-centre trial showed a 2.39ml / min / 1.73m² difference in estimated glomerular filtration rate (eGFR) change from baseline as compared to placebo at week 136, four weeks after ending treatment.
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A total of 340 patients, all with biopsy-confirmed IgA nephropathy and baseline total proteinuria of at least 1g/day despite optimised renin-angiotensin system (RAS) inhibitor treatment, were randomised to receive either daily oral Vanrafia (0.75mg) or placebo over nearly 132 weeks.
Patients continued their maximum tolerated and stable dose of RAS inhibitor throughout.
An additional group of 64 patients received a sodium-glucose co-transporter-2 (SGLT2) inhibitor with an RAS inhibitor for at least 12 weeks.
The primary efficacy endpoint for interim analysis (in 270 patients) was the change in proteinuria measured by 24-hour urine protein-to-creatinine ratio (UPCR) from baseline to week 36. The key secondary endpoint for the final analysis was the change in eGFR from baseline to week 136.
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By GlobalDataClinically meaningful results were observed for eGFR change from baseline at the end of treatment (week 132), including in those also receiving SGLT2 inhibitors. At week 132, the eGFR change from baseline versus placebo was 2.59ml / min / 1.73m².
Novartis cardiovascular, renal and metabolic development unit global head Ruchira Glaser said: “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. 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.”
Novartis is also pursuing developments in its broader IgAN portfolio, including Fabhalta (iptacopan) and the investigational compound zigakibart.
In December 2025, Novartis reported positive outcomes from the VAYHIT2 Phase III trial assessing ianalumab plus eltrombopag to treat patients with primary immune thrombocytopenia (ITP) who had prior corticosteroid treatment.
