{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T15:29:33Z","timestamp":1786980573262,"version":"build-2736575974"},"reference-count":17,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2020,8,20]],"date-time":"2020-08-20T00:00:00Z","timestamp":1597881600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2020,8,20]],"date-time":"2020-08-20T00:00:00Z","timestamp":1597881600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100013170","name":"Ono Pharmaceutical","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100013170","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Clin Exp Nephrol"],"published-print":{"date-parts":[[2021,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Etelcalcetide is a second-generation calcimimetic for the management of secondary hyperparathyroidism (SHPT) in patients on dialysis. We performed a post-marketing surveillance (PMS) to obtain information on the safety and efficacy of etelcalcetide in clinical practice in Japan.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This PMS enrolled SHPT patients who started initial treatment with etelcalcetide between April 1, 2017 and February 28, 2018 in Japan. Safety [adverse drug reactions (ADRs)] and efficacy [serum intact parathyroid hormone (iPTH), corrected calcium (cCa), phosphorous (P), and alkaline phosphatase (ALP)] were recorded for up to 52\u00a0weeks or until treatment discontinuation. Treatment decisions were at the physician\u2019s discretion.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of 1226 patients enrolled across 282 centers, safety and efficacy data were available for 1195 and 1192, respectively, while 933 continued treatment to Week 52. The starting dose was 5\u00a0mg in 82.0% of patients. There were 218 ADRs in 169 patients (14.1%). Metabolism and nutrition disorders (8.8%), adverse laboratory test results (1.8%), and gastrointestinal disorders (1.6%) were the most frequent classes of ADRs. Hypocalcemia-related ADRs occurred in 104 patients (8.7%). The percentage of patients with iPTH levels within the target range (60\u2013240\u00a0pg\/mL) steadily increased from 19.5% at Week 0 to 64.1% at Week 52 or last dose. cCa, P, and ALP levels remained well controlled.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This was the first real-world, large-scale, long-term observational PMS of etelcalcetide in Japan. We did not observe any new safety concerns. Etelcalcetide was associated with clinically relevant improvements in serum iPTH and maintenance of serum cCa, P, and ALP levels.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s10157-020-01936-2","type":"journal-article","created":{"date-parts":[[2020,8,20]],"date-time":"2020-08-20T09:04:23Z","timestamp":1597914263000},"page":"66-79","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Safety and efficacy of etelcalcetide, an intravenous calcimimetic, for up to 52\u00a0weeks in hemodialysis patients with secondary hyperparathyroidism: results of a post-marketing surveillance in Japan"],"prefix":"10.1007","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6122-592X","authenticated-orcid":false,"given":"Keitaro","family":"Yokoyama","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masafumi","family":"Fukagawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Shigematsu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Akiba","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ken","family":"Yoshikawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akira","family":"Tsuchiya","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Misato","family":"Kuwabara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tadao","family":"Akizawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,8,20]]},"reference":[{"issue":"4","key":"1936_CR1","doi-asserted-by":"crossref","first-page":"913","DOI":"10.2215\/CJN.06040710","volume":"6","author":"J Cunningham","year":"2011","unstructured":"Cunningham J, Locatelli F, Rodriguez M. Secondary hyperparathyroidism: pathogenesis, disease progression, and therapeutic options. Clin J Am Soc Nephrol. 2011;6(4):913\u201321.","journal-title":"Clin J Am Soc Nephrol"},{"issue":"3","key":"1936_CR2","doi-asserted-by":"crossref","first-page":"F367","DOI":"10.1152\/ajprenal.00061.2002","volume":"283","author":"J Silver","year":"2002","unstructured":"Silver J, Kilav R, Naveh-Many T. Mechanisms of secondary hyperparathyroidism. Am J Physiol Renal Physiol. 2002;283(3):F367\u201376.","journal-title":"Am J Physiol Renal Physiol"},{"issue":"1","key":"1936_CR3","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.kisu.2017.04.001","volume":"7","author":"Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group","year":"2017","unstructured":"Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 clinical practice guideline update for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease-mineral and bone disorder CKD-MBD. Kidney Int Suppl (2011). 2017;7(1):1\u201359.","journal-title":"Kidney Int Suppl (2011)."},{"issue":"3","key":"1936_CR4","doi-asserted-by":"crossref","first-page":"247","DOI":"10.1111\/1744-9987.12058","volume":"17","author":"M Fukagawa","year":"2013","unstructured":"Fukagawa M, Yokoyama K, Koiwa F, Taniguchi M, Shoji T, Kazama JJ, et al. Clinical practice guideline for the management of chronic kidney disease-mineral and bone disorder. Ther Apher Dial. 2013;17(3):247\u201388.","journal-title":"Ther Apher Dial"},{"issue":"5","key":"1936_CR5","doi-asserted-by":"crossref","first-page":"529","DOI":"10.1080\/14656566.2017.1303482","volume":"18","author":"N Hamano","year":"2017","unstructured":"Hamano N, Komaba H, Fukagawa M. Etelcalcetide for the treatment of secondary hyperparathyroidism. Expert Opin Pharmacother. 2017;18(5):529\u201334.","journal-title":"Expert Opin Pharmacother"},{"issue":"6","key":"1936_CR6","doi-asserted-by":"crossref","first-page":"717","DOI":"10.1002\/jcph.1090","volume":"58","author":"B Wu","year":"2018","unstructured":"Wu B, Melhem M, Subramanian R, Chen P, Jaramilla Sloey B, Fouqueray B, et al. Clinical pharmacokinetics and pharmacodynamics of etelcalcetide, a novel calcimimetic for treatment of secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis. J Clin Pharmacol. 2018;58(6):717\u201326.","journal-title":"J Clin Pharmacol"},{"issue":"2","key":"1936_CR7","doi-asserted-by":"crossref","first-page":"426","DOI":"10.1007\/s10157-017-1442-5","volume":"22","author":"T Shigematsu","year":"2018","unstructured":"Shigematsu T, Fukagawa M, Yokoyama K, Akiba T, Fujii A, Odani M, et al. Long-term effects of etelcalcetide as intravenous calcimimetic therapy in hemodialysis patients with secondary hyperparathyroidism. Clin Exp Nephrol. 2018;22(2):426\u201336.","journal-title":"Clin Exp Nephrol"},{"issue":"7","key":"1936_CR8","doi-asserted-by":"crossref","first-page":"1066","DOI":"10.3390\/jcm8071066","volume":"8","author":"D Russo","year":"2019","unstructured":"Russo D, Tripepi R, Malberti F, Di Iorio B, Scognamiglio B, Di Lullo L, et al. Etelcalcetide in patients on hemodialysis with severe secondary hyperparathyroidism. Multicenter study in \u201creal life\u201d. J Clin Med. 2019;8(7):1066.","journal-title":"J Clin Med"},{"issue":"12","key":"1936_CR9","doi-asserted-by":"crossref","first-page":"2099","DOI":"10.1016\/j.clinthera.2018.10.016","volume":"40","author":"T Shigematsu","year":"2018","unstructured":"Shigematsu T, Fukagawa M, Yokoyama K, Akiba T, Fujii A, Odani M, et al. Effects of the intravenous calcimimetic etelcalcetide on bone turnover and serum fibroblast growth factor 23: post hoc analysis of an open-label study. Clin Ther. 2018;40(12):2099\u2013111.","journal-title":"Clin Ther"},{"issue":"9","key":"1936_CR10","doi-asserted-by":"crossref","first-page":"756","DOI":"10.1136\/jclinpath-2011-200100","volume":"64","author":"K Sumida","year":"2011","unstructured":"Sumida K, Nakamura M, Ubara Y, Marui Y, Tanaka K, Takaichi K, et al. Histopathological alterations of the parathyroid glands in haemodialysis patients with secondary hyperparathyroidism refractory to cinacalcet hydrochloride. J Clin Pathol. 2011;64(9):756\u201360.","journal-title":"J Clin Pathol"},{"issue":"6","key":"1936_CR11","doi-asserted-by":"crossref","first-page":"811","DOI":"10.1530\/EJE-12-0947","volume":"168","author":"C Vulpio","year":"2013","unstructured":"Vulpio C, Bossola M, Di Stasio E, Tazza L, Silvestri P, Fadda G. Histology and immunohistochemistry of the parathyroid glands in renal secondary hyperparathyroidism refractory to vitamin D or cinacalcet therapy. Eur J Endocrinol. 2013;168(6):811\u20139.","journal-title":"Eur J Endocrinol"},{"issue":"10","key":"1936_CR12","doi-asserted-by":"crossref","first-page":"e0186093","DOI":"10.1371\/journal.pone.0186093","volume":"12","author":"MD J\u00e4ger","year":"2017","unstructured":"J\u00e4ger MD, Serttas M, Beneke J, M\u00fcller JA, Schrem H, Kaltenborn A, et al. Risk-factors for nodular hyperplasia of parathyroid glands in sHPT patients. PLoS ONE. 2017;12(10):e0186093.","journal-title":"PLoS ONE"},{"issue":"3","key":"1936_CR13","doi-asserted-by":"crossref","first-page":"E557","DOI":"10.1152\/ajpendo.00261.2001","volume":"282","author":"B Halloran","year":"2002","unstructured":"Halloran B, Ud\u00e9n P, Duh Q-Y, Kikuchi S, Wieder T, Cao J, et al. Parathyroid gland volume increases with postmaturational aging in the rat. Am J Physiol Endocrinol Metab. 2002;282(3):E557\u201363.","journal-title":"Am J Physiol Endocrinol Metab"},{"issue":"6","key":"1936_CR14","first-page":"2192","volume":"81","author":"BP Halloran","year":"1996","unstructured":"Halloran BP, Lonergan ET, Portale AA. Aging and renal responsiveness to parathyroid hormone in healthy men. J Clin Endocrinol Metab. 1996;81(6):2192\u20137.","journal-title":"J Clin Endocrinol Metab"},{"issue":"1 Pt 1","key":"1936_CR15","first-page":"E139","volume":"272","author":"AA Portale","year":"1997","unstructured":"Portale AA, Lonergan ET, Tanney DM, Halloran BP. Aging alters calcium regulation of serum concentration of parathyroid hormone in healthy men. Am J Physiol. 1997;272(1 Pt 1):E139\u201346.","journal-title":"Am J Physiol"},{"issue":"6","key":"1936_CR16","doi-asserted-by":"crossref","first-page":"1913","DOI":"10.3390\/nu5061913","volume":"5","author":"V Tejwani","year":"2013","unstructured":"Tejwani V, Qian Q. Calcium regulation and bone mineral metabolism in elderly patients with chronic kidney disease. Nutrients. 2013;5(6):1913\u201336.","journal-title":"Nutrients"},{"issue":"8","key":"1936_CR17","doi-asserted-by":"crossref","first-page":"634","DOI":"10.1111\/nep.13682","volume":"25","author":"T Shigematsu","year":"2020","unstructured":"Shigematsu T, Fukagawa M, Yokoyama K, Akiba T, Fujii A, Shinoda A, et al. Influence of dialysate Ca concentrations on the therapeutic effects of etelcalcetide with concomitant drugs in patients with secondary hyperparathyroidism. Nephrology (Carlton). 2020;25(8): 634\u201343.","journal-title":"Nephrology (Carlton)"}],"container-title":["Clinical and Experimental Nephrology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10157-020-01936-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10157-020-01936-2\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10157-020-01936-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,8,19]],"date-time":"2021-08-19T20:19:29Z","timestamp":1629404369000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10157-020-01936-2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,8,20]]},"references-count":17,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,1]]}},"alternative-id":["1936"],"URL":"https:\/\/doi.org\/10.1007\/s10157-020-01936-2","relation":{},"ISSN":["1342-1751","1437-7799"],"issn-type":[{"value":"1342-1751","type":"print"},{"value":"1437-7799","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,8,20]]},"assertion":[{"value":"12 March 2020","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"16 July 2020","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"20 August 2020","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Compliance with ethical standards"}},{"value":"Keitaro Yokoyama has received honoraria from Torii Pharmaceutical Co., Ltd., ONO Pharmaceutical Co., Ltd., and Kyowa Kirin Co., Ltd. Masafumi Fukagawa has received honoraria from ONO Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., and Bayer Yakuhin Ltd.; research grants from Kyowa Kirin Co., Ltd.; and subsidies\/donations from Kyowa Kirin Co., Ltd. Takashi Shigematsu has received honoraria from Torii Pharmaceutical Co., Ltd., ONO Pharmaceutical Co., Ltd., Bayer Yakuhin Ltd., Kissei Pharmaceutical Co., Ltd., and Kyowa Kirin Co., Ltd.; research grants from ONO Pharmaceutical Co., Ltd. and Fujiyakuhin Co., Ltd.; and subsidies\/donations from ONO Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., and Chugai Pharmaceutical Co., Ltd. Takashi Akiba has nothing to disclose. Ken Yoshikawa, Akira Tsuchiya, and Misato Kuwabara are employees of ONO Pharmaceutical Co., Ltd. Tadao Akizawa has received honoraria from ONO Pharmaceutical Co., Ltd., Torii Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Kissei Pharmaceutical Co., Ltd., Bayer Yakuhin Ltd., Sanwa Kagaku Kenkyusho Co., Ltd., Astellas Pharma Inc., and Fuso Pharmaceutical Industries, Ltd.; has received fees for serving on advisory boards for Japan Tobacco Inc., Kyowa Kirin Co., Ltd., Otsuka Pharmaceutical Co., Ltd., and Nipro Corporation; and has received author fees from Astellas Pharma Inc.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This surveillance was conducted in accordance with Good Post-marketing Study Practice in Japan, for which the need for ethical approval is waived.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Research involving human participants"}},{"value":"Informed consent is not necessary for post-marketing surveillance using anonymized data collected in routine clinical practice for post-marketing evaluation of drug safety.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}