Phase III PROTECT Study evaluating Filspari in IgA nephropathy presented at World Congress of Nephrology 2023 and published in The Lancet.- Travere Therapeutics
Travere Therapeutics announced publication in The Lancet of the interim analysis of efficacy and safety data from the ongoing pivotal, Phase III PROTECT Study evaluating Filspari (sparsentan) in adults with IgA nephropathy (IgAN). The data are simultaneously being presented in a late-breaking trials session at the World Congress of Nephrology 2023, in Bangkok, Thailand.
The analysis published in The Lancet show that after 36 weeks of treatment, patients receiving Filspari achieved a mean reduction in proteinuria from baseline of 49.8%, compared to a mean reduction in proteinuria from baseline of 15.1% for irbesartan-treated patients (p<0.0001). during the double-blind treatment period, a significantly greater proportion of patients on filspari achieved complete remission (urine protein excretion><0.3 g day) and partial remission (urine protein excretion><1.0 g day) of proteinuria compared to patients on irbesartan. complete remission at any time over the course of the double-blind treatment period occurred in 20.8% of participants in the filspari group and 7.9% of participants in the irbesartan group (p="0.0005)." 70.3% of participants in the filspari group achieved partial remission, compared to 44.1% of participants in the irbesartan group (p><0.0001).></0.0001).></1.0></0.3></0.0001).>
Results from the interim assessment in the PROTECT Study 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. The analysis published in The Lancet includes available efficacy data through the cutoff date of August 1, 2021, and available safety data through the cutoff date of February 1, 2022.
See: "Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial" Prof Hiddo J L Heerspink et al. The Lancet April 01, 2023DOI:https://doi.org/10.1016/S0140-6736(23)00569-X
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