{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T13:12:27Z","timestamp":1791637947122,"version":"4.3.4"},"reference-count":25,"publisher":"Springer Science and Business Media LLC","issue":"10","license":[{"start":{"date-parts":[[2021,6,10]],"date-time":"2021-06-10T00:00:00Z","timestamp":1623283200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,6,10]],"date-time":"2021-06-10T00:00:00Z","timestamp":1623283200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100002336","name":"Daiichi Sankyo Company","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100002336","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Clin Exp Nephrol"],"published-print":{"date-parts":[[2021,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Esaxerenone has potential renoprotective effects and reduces the urinary albumin-to-creatinine ratio (UACR) in patients with diabetic kidney disease and overt nephropathy. We investigated the efficacy and safety of esaxerenone in Japanese patients with type 2 diabetes (T2D) and macroalbuminuria (UACR\u2009\u2265\u2009300\u00a0mg\/g creatinine).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>We conducted a multicenter, single-arm, open-label phase III study in 56 patients with T2D and UACR\u2009\u2265\u2009300\u00a0mg\/g creatinine with estimated glomerular filtration rate (eGFR)\u2009\u2265\u200930\u00a0mL\/min\/1.73 m<jats:sup>2<\/jats:sup> and treated with a renin\u2013angiotensin system inhibitor. Patients received esaxerenone for 28\u00a0weeks at 1.25\u00a0mg\/day initially with titration to 2.5\u00a0mg\/day based on serum potassium (K<jats:sup>+<\/jats:sup>) monitoring. Efficacy was evaluated as the change in UACR from baseline to week 28. Safety endpoints included adverse events (AEs), incidence of serum K<jats:sup>+<\/jats:sup> increase, and change in eGFR from baseline.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>UACR decreased by 54.6% (95% CI 46.9%, 61.3%) on average from baseline (544.1\u00a0mg\/g creatinine) to the\u00a0end of treatment (246.8\u00a0mg\/g creatinine); 51.8% of patients showed improvement to early nephropathy. AE incidence was 69.6%. Three patients (5.4%) had serum K<jats:sup>+<\/jats:sup> levels\u2009\u2265\u20096.0\u00a0mEq\/L or\u2009\u2265\u20095.5\u00a0mEq\/L on two consecutive occasions. Hyperkalemia in two patients was transient and resolved during the treatment period. One patient discontinued following two consecutive serum K<jats:sup>+<\/jats:sup> values\u2009\u2265\u20095.5\u00a0mEq\/L. The maximum change from baseline in eGFR was\u2009\u2212\u20098.3\u00a0mL\/min\/1.73 m<jats:sup>2<\/jats:sup> at week 24.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Esaxerenone reduced UACR in Japanese patients with T2D and UACR\u2009\u2265\u2009300\u00a0mg\/g creatinine; more than half experienced a transition from UACR\u2009\u2265\u2009300\u00a0mg\/g creatinine to UACR\u2009&lt;\u2009300\u00a0mg\/g creatinine.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Clinical trial registration<\/jats:title>\n                <jats:p>JapicCTI-173696<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s10157-021-02075-y","type":"journal-article","created":{"date-parts":[[2021,6,10]],"date-time":"2021-06-10T13:07:40Z","timestamp":1623330460000},"page":"1070-1078","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":38,"title":["Efficacy and safety of esaxerenone (CS-3150) in Japanese patients with type 2 diabetes and macroalbuminuria: a multicenter, single-arm, open-label phase III study"],"prefix":"10.1007","volume":"25","author":[{"given":"Sadayoshi","family":"Ito","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naoki","family":"Kashihara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenichi","family":"Shikata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masaomi","family":"Nangaku","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Wada","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuyuki","family":"Okuda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomoko","family":"Sawanobori","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,6,10]]},"reference":[{"key":"2075_CR1","doi-asserted-by":"publisher","first-page":"2032","DOI":"10.2215\/CJN.11491116","volume":"12","author":"RZ Alicic","year":"2017","unstructured":"Alicic RZ, Rooney MT, Tuttle KR. 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All patients provided written informed consent prior to enrollment in the study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}}]}}