How effective is sparsentane in treating kidney disease?

斯帕森坦(sparsentan)是一种内皮素和血管紧张素II受体拮抗剂，用于减少有快速疾病进展风险的原发性免疫球蛋白A肾病成人的蛋白尿。斯帕森坦是一种新型、非免疫抑制、单分子、双重内皮素和血管紧张素受体拮抗剂，正在进行针对成人IgA肾病的3期试验。

Methods: PROTECT was an international, randomized, double-blind, active-controlled study conducted at 134 clinical practice sites in 18 countries. This study examined the efficacy of sparsentan versus irbesartan in adults (age≥18 years) with biopsy-provenIgAnephropathy despite maximal renin use pan>-Angiotensin system inhibitor therapy for at least 12 weeks, but proteinuria remains 10g/ days or higher. Participants were randomly assigned in a 1:1 ratio to receive once-daily sparsentan400 mg or once-daily irbesartan300 mg，根据筛选时估计的肾小球滤过率进行分层（30至《60mL/min/173m2以及每1 73meters≥60ml/minutes2) and urinary protein excretion at screening (≤1 75grams/days》1 75grams/days). The primary efficacy endpoint was the change from baseline to week 36 in urine protein-to-creatinine ratio based on 24-hour urine samples, assessed using a mixed model for repeated measures. Treatment-emergent adverse events (TEAEs) is the safety end point. All endpoints were examined for all participants who received at least one dose of randomized treatment.

Survey results: From 2018year12month20 to2021year5month26day, 404 participants were randomly assigned to Sparsentan(n = 202) or irbesartan (n = 202) and receive treatment. At week 36, the geometric least squares mean percentage change in the urine protein-creatinine ratio was statistically significantly greater in the sparsentan group compared with baseline. In the irbesartan group (-49.8%), resulting in a relative reduction of 41% between groups (least squares mean ratio= 0.59;95%confidence interval is0.51-0.69;p < 0 0001). TEAEs with spasentan are similar to those with irbesartan. There were no cases of severe edema, heart failure, hepatotoxicity, or edema-related discontinuation. Weight change from baseline did not differ between the parsentan and irbesartan groups.

Explanation:In adults with IgA nephropathy, once-daily treatment with spaxentan significantly reduced proteinuria compared with irbesartan. The safety profile of sparsentan is similar to that of irbesartan. If you want to get more high-quality information, you can contact YaDE. YaDE will do its best to learn more about high-quality overseas drugs for you.

xa0