{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,23]],"date-time":"2026-02-23T10:45:22Z","timestamp":1771843522612,"version":"3.50.1"},"reference-count":32,"publisher":"Oxford University Press (OUP)","issue":"12","license":[{"start":{"date-parts":[[2023,9,5]],"date-time":"2023-09-05T00:00:00Z","timestamp":1693872000000},"content-version":"vor","delay-in-days":1,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Sanwa Kagaku Kenkyusho Co., Ltd"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,11,30]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Upacicalcet is a novel small-molecule calcimimetic agent developed for intravenous injection. Here, we evaluated the long-term efficacy and safety of upacicalcet treatment via intraindividual dose adjustment in haemodialysis patients with secondary hyperparathyroidism (SHPT).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>A phase 2, multicentre, open-label, single-arm study was conducted. Upacicalcet was administered for 52\u00a0weeks; the starting dose was 50\u00a0\u03bcg thrice a week, and then adjusted to 25, 50, 100, 150, 200, 250, or 300\u00a0\u03bcg, according to the dose-adjustment method set in the protocol. The primary endpoint was the percentage of patients with serum intact parathyroid hormone (iPTH) level achieving a target range of 60\u2013240\u00a0pg\/mL (target achievement rate) at week 18.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>A total of 58 patients were administered upacicalcet. The target achievement rate of serum iPTH level at week 18 was 57.9%, which increased to 80.8% at week 52. The serum-corrected calcium (cCa) level decreased immediately after upacicalcet administration, but no further decrease was observed. Adverse events were observed in 94.8% of patients, and adverse drug reactions (ADRs) occurred in 20.7% of patients. The most common ADR was decreased adjusted calcium in eight patients; dizziness occurred as a serious ADR in one patient. The serum cCa level of patients who interrupted upacicalcet treatment at a serum cCa level of &amp;lt;7.5\u00a0mg\/dL recovered to \u22657.5\u00a0mg\/dL immediately after the interruption.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>In haemodialysis patients with SHPT, upacicalcet doses of 25\u2013300\u00a0\u03bcg for 52 weeks were found to be highly effective and well-tolerated, with minor safety concerns.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ckj\/sfad213","type":"journal-article","created":{"date-parts":[[2023,9,5]],"date-time":"2023-09-05T05:42:28Z","timestamp":1693892548000},"page":"2614-2625","source":"Crossref","is-referenced-by-count":4,"title":["Phase 2 study of upacicalcet in Japanese haemodialysis patients with secondary hyperparathyroidism: an intraindividual dose-adjustment study"],"prefix":"10.1093","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3977-5933","authenticated-orcid":false,"given":"Daijo","family":"Inaguma","sequence":"first","affiliation":[{"name":"Department of Internal Medicine, Fujita Health University Bantane Hospital , Aichi , Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fumihiko","family":"Koiwa","sequence":"additional","affiliation":[{"name":"Division of Nephrology, Department of Internal Medicine, Showa University Fujigaoka Hospital , Yokohama , Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masanori","family":"Tokumoto","sequence":"additional","affiliation":[{"name":"Department of Nephrology, Japanese Red Cross Fukuoka Hospital , Fukuoka , Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7832-2339","authenticated-orcid":false,"given":"Masafumi","family":"Fukagawa","sequence":"additional","affiliation":[{"name":"Division of Nephrology, Endocrinology, and Metabolism, Department of Internal Medicine, Tokai University School of Medicine , Kanagawa , Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-0097-532X","authenticated-orcid":false,"given":"Shinji","family":"Yoneda","sequence":"additional","affiliation":[{"name":"Medical Affairs Department, Sanwa Kagaku Kenkyusho Co., Ltd , Nagoya , Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hisami","family":"Yasuzawa","sequence":"additional","affiliation":[{"name":"Medical Affairs Department, Sanwa Kagaku Kenkyusho Co., Ltd , Nagoya , Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kenji","family":"Asano","sequence":"additional","affiliation":[{"name":"Clinical Development Department, Sanwa Kagaku Kenkyusho Co., Ltd , Nagoya , Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Keiko","family":"Hagita","sequence":"additional","affiliation":[{"name":"Clinical Development Department, Sanwa Kagaku Kenkyusho Co., Ltd , Nagoya , Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yosuke","family":"Inagaki","sequence":"additional","affiliation":[{"name":"Clinical Development Department, Sanwa Kagaku Kenkyusho Co., Ltd , Nagoya , Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5624-7553","authenticated-orcid":false,"given":"Daisuke","family":"Honda","sequence":"additional","affiliation":[{"name":"Project Management Department, Sanwa Kagaku Kenkyusho Co., Ltd , Nagoya , 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