Sparsentan demonstrates sustained decline of proteinuria in patients with IgA nephropathy
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Key takeaways:
- At 36 weeks, patients receiving sparsentan experienced a mean 49.8% reduction in proteinuria from baseline.
- Treatment-emergent adverse events were similar between both treatment groups.
Daily treatment of sparsentan led to a greater reduction of proteinuria in patients with IgA nephropathy compared with irbesartan treatment, according to a study published in The Lancet.
“The data demonstrate the significant and clinically meaningful anti-proteinuric effect of sparsentan compared to irbesartan,” Brad Rovin, MD, 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, said in an accompanying press release. “The data also highlight a consistent treatment effect across patient populations, regardless of age, race, gender, clinical characteristics and concomitant medications.”
In the ongoing, randomized, double-blind PROTECT study, researchers examine the impact of sparsentan, also known as Filspari (Travere Therapeutics), vs. irbesartan in adults with IgA nephropathy. Participants have proteinuria of 1 g/day or higher.
Researchers randomized patients 1:1 to receive 400 mg of sparsentan daily (n=202) or 300 mg of irbesartan daily (n=202) between Dec. 20, 2018, and May 26, 2021. Patients were then stratified by eGFR and urine protein excretion at screening. Researchers determined the urine protein-creatine ratio at baseline and the 36-week mark using a 24-hour urine sample and mixed model repeated measures.
At 36 weeks, patients receiving sparsentan experienced a mean 49.8% reduction in proteinuria from baseline, whereas patients receiving irbesartan experienced a mean 15.1% reduction. Further, more patients receiving sparsentan achieved complete remission of proteinuria (20.8%) during the double-blind period compared with the patients receiving irbesartan (7.9%), according to a press release. Further, 70.3% of patients receiving sparsentan achieved partial remission compared with 44.1% of those receiving irbesartan.
The treatment-emergent adverse events were similar between both treatment groups.
“The interim data from the largest interventional trial testing a novel molecule vs. an active comparator in IgA nephropathy conducted to date clearly demonstrate the more rapid and sustained reduction in proteinuria compared to irbesartan, including a significantly greater proportion of patients achieving complete and partial remission with Filspari,” Jula Inrig, MD, chief medical officer of Travere Therapeutics, said in the release. “These interim results also strengthen our confidence for a potential longer-term benefit on eGFR, which will be further examined at the completion of the 2-year double-blind period of the PROTECT trial later this year. We are thrilled to share this data with all those working to improve outcomes for people living with rare kidney disease.”
Reference:
- Travere Therapeutics announces interim analysis from the phase 3 PROTECT study of Filsari (Sparsentan) in IgA nephropathy published in The Lancet and presented at World Congress of Nephrology 2023. https://ir.travere.com/news-releases/news-release-details/travere-therapeutics-announces-interim-analysis-phase-3-protect. Published April 1, 2023. Accessed April 4, 2023.
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