{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T04:34:32Z","timestamp":1789706072710,"version":"4.0.1"},"reference-count":32,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"8","funder":[{"DOI":"10.13039\/501100002973","name":"Daiichi-Sankyo","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100002973","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["CJASN"],"published-print":{"date-parts":[[2019,8]]},"abstract":"<jats:sec>\n                    <jats:title>Background and objectives<\/jats:title>\n                    <jats:p>The progression of kidney disease in some patients with type 2 diabetes mellitus may not be adequately suppressed by renin-angiotensin system inhibitors. Esaxerenone (CS-3150) is a nonsteroidal mineralocorticoid receptor blocker that has shown kidney protective effects in preclinical studies, and it is a potential add-on therapy to treat diabetic kidney disease. This phase 2 study evaluated the efficacy and safety of esaxerenone in Japanese patients with type 2 diabetes mellitus and microalbuminuria.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design, setting, participants, &amp; measurements<\/jats:title>\n                    <jats:p>\n                      This multicenter, randomized, double-blind, placebo-controlled trial enrolled 365 hypertensive or normotensive patients with type 2 diabetes mellitus and microalbuminuria (urinary albumin-to-creatinine ratio \u226545 to &lt;300 mg\/g creatinine) treated with renin-angiotensin system inhibitor who had eGFR\u226530 ml\/min per 1.73 m\n                      <jats:sup>2<\/jats:sup>\n                      . Participants were randomized to receive 0.625, 1.25, 2.5, or 5 mg\/d esaxerenone or placebo for 12 weeks. The primary end point was the change in urinary albumin-to-creatinine ratio from baseline to week 12 (with last observation carried forward).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Esaxerenone treatment at 1.25, 2.5, and 5 mg\/d significantly reduced urinary albumin-to-creatinine ratio by the end of treatment (38%, 50%, and 56%, respectively) compared with placebo (7%; all\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt;0.001). The urinary albumin-to-creatinine ratio remission rate (defined as urinary albumin-to-creatinine ratio &lt;30 mg\/g creatinine at the end of treatment and \u226530% decrease from baseline) was 21% in the 2.5- and 5-mg\/d groups versus 3% for placebo (both\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt;0.05). Adverse events occurred slightly more frequently with esaxerenone versus placebo, but the frequencies of drug-related adverse events and discontinuation rates were similar in the placebo and the 0.625-, 1.25-, and 2.5-mg\/d groups. Drug-related adverse events and treatment discontinuations were marginally higher in the 5-mg\/d group. The most common drug-related adverse event was hyperkalemia, which was dose proportional.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Adding esaxerenone at 1.25, 2.5, and 5 mg\/d for 12 weeks to an ongoing renin-angiotensin system inhibitor significantly reduces urinary albumin-to-creatinine ratio in patients with type 2 diabetes mellitus and microalbuminuria.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2215\/cjn.14751218","type":"journal-article","created":{"date-parts":[[2019,6,27]],"date-time":"2019-06-27T14:45:19Z","timestamp":1561646719000},"page":"1161-1172","source":"Crossref","is-referenced-by-count":107,"title":["Efficacy and Safety of Esaxerenone (CS-3150) for the Treatment of Type 2 Diabetes with Microalbuminuria"],"prefix":"10.2215","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct02345057","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Sadayoshi","family":"Ito","sequence":"first","affiliation":[{"name":"Division of Nephrology, Endocrinology and Vascular Medicine, Department of Medicine, Tohoku University School of Medicine, Sendai, Japan;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenichi","family":"Shikata","sequence":"additional","affiliation":[{"name":"Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masaomi","family":"Nangaku","sequence":"additional","affiliation":[{"name":"Division of Nephrology and Endocrinology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuyuki","family":"Okuda","sequence":"additional","affiliation":[{"name":"Biostatistics and Data Management Department, and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomoko","family":"Sawanobori","sequence":"additional","affiliation":[{"name":"Clinical Development Department Daiichi-Sankyo Co., Ltd., Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2019,6,27]]},"reference":[{"issue":"Suppl 1","key":"B1-20230813","first-page":"S79","article-title":"Nephropathy in diabetes.","volume":"27","author":"Molitch","year":"2004","journal-title":"Diabetes Care"},{"key":"B2-20230813","first-page":"28","article-title":"Diabetes and end-stage renal disease; a review article on new concepts.","volume":"4","author":"Ghaderian","year":"2015","journal-title":"J Renal Inj 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