Novartis reported final 2.5‑year Phase III ALIGN trial results showing that Vanrafia (atrasentan) slowed kidney function decline versus placebo in adults with IgA nephropathy (IgAN). The findings, published in The Lancet and presented at the European Renal Association Congress, showed that treatment with Vanrafia reduced the rate of kidney function decline by about 34% compared with placebo based on a supportive estimated glomerular filtration rate (eGFR) slope analysis.
Vanrafia also reduced protein in the urine by 38.3% versus placebo at nine months, with these reductions sustained through the end of treatment. Estimated glomerular filtration rate changes from baseline favored Vanrafia, and benefits were consistent across different measures of kidney function. Patients receiving background sodium‑glucose co‑transporter‑2 (SGLT2) inhibitors also consistently showed slower kidney function decline with Vanrafia compared with placebo.
Richard Lafayette, MD, FACP, professor of medicine (nephrology) and director of the Glomerular Disease Center at Stanford University Medical Center, and an ALIGN study investigator and steering committee member, said the results provide robust evidence of clinically meaningful slowing of kidney function decline over more than two years of treatment and reinforce earlier findings on proteinuria reduction. He noted that the data highlight the role of a highly selective endothelin A receptor antagonist as part of an evolving treatment approach for IgAN.
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