{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,25]],"date-time":"2026-07-25T16:20:53Z","timestamp":1784996453917,"version":"3.55.0"},"reference-count":21,"publisher":"Springer Science and Business Media LLC","issue":"6","license":[{"start":{"date-parts":[[2019,4,6]],"date-time":"2019-04-06T00:00:00Z","timestamp":1554508800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2019,4,6]],"date-time":"2019-04-06T00:00:00Z","timestamp":1554508800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Clin Exp Nephrol"],"published-print":{"date-parts":[[2019,6,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Secondary hyperparathyroidism (SHPT) is a serious and common complication in patients receiving peritoneal dialysis (PD). Cinacalcet is currently the recommended therapy for SHPT; however, gastrointestinal (GI)-related symptoms can result in low adherence and high discontinuation rates. Evocalcet is a novel calcimimetic agent that has non-inferior efficacy while providing a more tolerable safety profile.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This was a multicenter, intra-subject dose-adjustment treatment study evaluating the efficacy and safety of 1\u20138\u00a0mg evocalcet orally administered once daily for 32 weeks for the treatment of SHPT in PD patients. Patients then entered a 20-week extension period (dose range 1\u201312\u00a0mg). The primary endpoint was the proportion of patients who achieved a mean intact parathyroid hormone (iPTH) level of 60\u2013240\u00a0pg\/mL during the evaluation period (weeks 30\u201332). Secondary efficacy endpoints included the proportion of patients achieving\u2009\u2265\u200930% decrease in iPTH levels.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 39 Japanese PD patients with SHPT received evocalcet. The target mean iPTH level of 60\u2013240\u00a0pg\/mL was achieved by 71.8% (28\/39) of patients during the evaluation period and 83.3% (20\/24) of patients at week 52. The proportion of patients who achieved\u2009\u2265\u200930% decrease in iPTH levels from baseline was 74.4% (29\/39) during the evaluation period and 87.5% (21\/24) at week 52. Adverse drug reactions occurred in 46.2% (18\/39) of patients, with most being of mild-to-moderate severity including GI-related events.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This study shows the long-term efficacy and safety of evocalcet when orally administered to PD patients with SHPT once daily.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trial registration<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov: NCT02549417,\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02549417\">https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02549417<\/jats:ext-link>\n                      ; JAPIC: JapicCTI-153016,\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.clinicaltrials.jp\/user\/showCteDetailE.jsp?japicId=JapicCTI-153016\">http:\/\/www.clinicaltrials.jp\/user\/showCteDetailE.jsp?japicId=JapicCTI-153016<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s10157-019-01692-y","type":"journal-article","created":{"date-parts":[[2019,4,6]],"date-time":"2019-04-06T21:34:27Z","timestamp":1554586467000},"page":"739-748","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Efficacy and safety of evocalcet in Japanese peritoneal dialysis patients"],"prefix":"10.1007","volume":"23","clinical-trial-number":[{"clinical-trial-number":"nct02549417","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Kazuhiko","family":"Tsuruya","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryutaro","family":"Shimazaki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masafumi","family":"Fukagawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tadao","family":"Akizawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"Evocalcet Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshimitsu","family":"Hayashi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hidetomo","family":"Nakamoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shoji","family":"Koga","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ichiro","family":"Okido","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Minoru","family":"Kubota","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fumihiko","family":"Koiwa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masahiro","family":"Takeda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Terumasa","family":"Hayashi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Makoto","family":"Hiramatsu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hideki","family":"Kawanishi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hidetoshi","family":"Kanai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sakuya","family":"Ito","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuhiko","family":"Tsuruya","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koji","family":"Mitsuiki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hirofumi","family":"Ikeda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2019,4,6]]},"reference":[{"key":"1692_CR1","doi-asserted-by":"publisher","first-page":"1975","DOI":"10.1016\/S0140-6736(14)61601-9","volume":"385","author":"T Liyanage","year":"2015","unstructured":"Liyanage T, Ninomiya T, Jha V, Neal B, Patrice HM, Okpechi I, et al. 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MF has received consulting fees from Kyowa Hakko Kirin Co., Ltd. and Ono Pharmaceutical Co., Ltd.; lecture fees from Kyowa Hakko Kirin Co., Ltd., Bayer Yakuhin, Ltd., Torii Pharmaceutical Co., Ltd. and Ono Pharmaceutical Co., Ltd.; and grants from Kyowa Hakko Kirin Co., Ltd. and Bayer Yakuhin, Ltd. TA has received consulting fees from Kyowa Hakko Kirin Co., Ltd., Astellas Pharma Inc., Bayer Yakuhin, Ltd., Fuso Pharmaceutical Industries, Ltd., Japan Tobacco Inc., Ono Pharmaceutical Co., Ltd. and NIPRO Industry, and lecture fees from Kyowa Hakko Kirin Co., Ltd., Chugai Pharmaceutical Co., Ltd., Bayer Yakuhin, Ltd., Kissei Pharmaceutical Co., Ltd., Torii Pharmaceutical Co., Ltd. and Ono Pharmaceutical Co., Ltd. RS is employed by Kyowa Hakko Kirin Co., Ltd., which funded this research.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This study was performed in compliance with ethical principles based on the Declaration of Helsinki and the Good Clinical Practice Guidelines. Ethical approval was obtained from the institutional review board of each participating institution.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"All patients provided written informed consent.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}