The National Kidney Foundation (NKF) will feature a late-breaking plenary session by Travere Therapeutics on the interim analysis of efficacy and safety data from the ongoing Phase 3 PROTECT Study evaluating FILSPARI™ (Sparsentan) in adults with IgA nephropathy (IgAN).
NEW YORK, April 13, 2023 /PRNewswire/ -- The National Kidney Foundation (NKF) will feature a late-breaking plenary session by Travere Therapeutics on the interim analysis of efficacy and safety data from the ongoing Phase 3 PROTECT Study evaluating FILSPARI™ (Sparsentan) in adults with IgA nephropathy (IgAN). “Rapid and Sustained Proteinuria Reduction with Sparsentan in Immunoglobulin A Nephropathy (IgAN): PROTECT Study Interim Results” will be presented Wednesday, April 12, at 5:15 CT, at the NKF Spring Clinical Meetings, the largest multidisciplinary gathering of kidney care professionals in North America, taking place in Austin, TX, from April 11-15. Data demonstrates a significant and clinically meaningful anti-proteinuric effect of Sparsentan compared to Irbesartan. IgAN is a rare kidney disease (RKD) affecting up to 150,000 people in the U.S., and a leading cause of kidney failure due to glomerular disease. “The data demonstrate the significant and clinically meaningful anti-proteinuric effect of Sparsentan compared to Irbesartan,” said Brad Rovin, M.D., Medical Director at Ohio State University Center for Clinical Research Management, Director of the Division for Nephrology, and steering committee member for the PROTECT Study. “The data also highlight a consistent treatment effect across patient populations, regardless of age, race, gender, clinical characteristics, and concomitant medications.” Highlights of the interim results from the PROTECT Study, the largest interventional trial testing a novel molecule versus an active comparator in IgA nephropathy to date, include:
Results from the interim assessment in the PROTECT Study also show that FILSPARI was well tolerated with a clearly defined safety profile that has been consistent across all clinical trials conducted to date with treatment-emergent adverse events (TEAEs) comparable to Irbesartan. No cases of severe edema, heart failure, hepatotoxicity, or edema-related discontinuations were reported in the study as of the cutoff date. Body weight and blood pressure changes from baseline were not different between the FILSPARI and Irbesartan groups. Data from the study were recently published in The Lancet and announced by Travere Therapeutics. Thousands of kidney care professionals will attend the Spring Clinical Meetings in-person and virtually. Hundreds of the latest studies and kidney care advances will be unveiled. About IgA Nephropathy NKF Spring Clinical Meetings About Kidney Disease NKF Professional Membership View original content to download multimedia:https://www.prnewswire.com/news-releases/interim-analysis-of-the-phase-3-protect-study-of-filspari-sparsentan-in-iga-nephropathy-presented-by-travere-therapeutics-at-nkf-spring-clinical-meetings-301796321.html SOURCE The National Kidney Foundation |