Novartis reviews closing information from the ALIGN research in IgAN
Novartis has introduced closing information from the Part III ALIGN trial, highlighting that Vanrafia (atrasentan) slowed the decline of kidney operate in adults with immunoglobulin A nephropathy (IgAN).
The randomized, international, double-blind, placebo-controlled, multicenter research confirmed a distinction of two.39 ml/min/1.73 m² within the estimated change from baseline in glomerular filtration fee (eGFR) in comparison with placebo at week 136, 4 weeks after the tip of remedy.
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Extra data
A complete of 340 sufferers, all with biopsy-confirmed IgA nephropathy and baseline whole proteinuria of at the very least 1 g/day regardless of optimized remedy with a renin-angiotensin system (RAS) inhibitor, had been randomized to obtain oral Vanrafia (0.75 mg) or placebo day by day for nearly 132 weeks.
Sufferers remained on their most tolerated and secure dose of RAS inhibitor all through remedy.
A further group of 64 sufferers acquired a sodium-glucose cotransporter-2 (SGLT2) inhibitor with a RAS inhibitor for at the very least 12 weeks.
The first efficacy endpoint for the interim evaluation (in 270 sufferers) was the change in proteinuria as measured by 24-hour urine protein-to-creatinine ratio (UPCR) from baseline to week 36. The important thing secondary endpoint for the ultimate evaluation was the change in eGFR from baseline to week 136.
Clinically significant outcomes had been noticed for eGFR change from baseline at finish of remedy (week 132), together with in those that additionally acquired SGLT2 inhibitors. At week 132, eGFR change from baseline versus placebo was 2.59 ml/min/1.73 m².
Ruchira Glaser, international head of cardiovascular, renal and metabolic improvement at Novartis, stated: “Progressive and complicated illnesses comparable to IgAN current an pressing want for medicines that may goal the a number of causes of the illness.
“Vanrafia might be seamlessly built-in into sufferers’ current remedy plans, with a constant security profile. We’re happy with the present Part III ALIGN outcomes, which add to the rising proof that Vanrafia is a possible basic remedy to gradual the decline of renal operate.”
Novartis can be pursuing developments in its broader IgAN portfolio, together with Fabhalta (iptacopan) and the investigational drug zigakibart.
In December 2025, Novartis reported constructive outcomes from the VAYHIT2 section III trial evaluating ianalumab plus eltrombopag for the remedy of sufferers with main immune thrombocytopenia (ITP) who had beforehand acquired corticosteroid remedy.
