{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T23:30:00Z","timestamp":1787009400547,"version":"build-2736575974"},"reference-count":37,"publisher":"Oxford University Press (OUP)","issue":"10","license":[{"start":{"date-parts":[[2017,1,5]],"date-time":"2017-01-05T00:00:00Z","timestamp":1483574400000},"content-version":"vor","delay-in-days":1,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2017,10,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Secondary hyperparathyroidism (SHPT) is a major complication associated with chronic kidney disease. We evaluated the efficacy and safety of etelcalcetide (ONO-5163\/AMG 416), a novel intravenous calcimimetic, in Japanese haemodialysis patients with SHPT.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel-group study, etelcalcetide was administered three times per week at an initial dose of 5\u2009mg, and subsequently adjusted to doses between 2.5 and 15\u2009mg at 4-week intervals for 12 weeks. A total of 155 SHPT patients with serum intact parathyroid hormone (iPTH) levels\u2009\u2265300\u2009pg\/mL were assigned to receive etelcalcetide (n\u2009=\u200978) or placebo (n\u2009=\u200977). The primary endpoint was the proportion of patients with decreased serum iPTH to the target range proposed by the Japanese Society for Dialysis Therapy (60\u2013240\u2009pg\/mL). The major secondary endpoint was the proportion of patients with\u2009\u226530% reductions in serum iPTH from baseline.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The proportion of patients meeting the primary endpoint was significantly higher for etelcalcetide (59.0%) versus placebo (1.3%). Similarly, the proportion of patients meeting the major secondary endpoint was significantly higher for etelcalcetide (76.9%) versus placebo (5.2%). Serum albumin-corrected calcium, phosphorus and intact fibroblast growth factor-23 levels were decreased in the etelcalcetide group. Nausea, vomiting and symptomatic hypocalcaemia were mild with etelcalcetide. Serious adverse events related to etelcalcetide were not observed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This study demonstrated the efficacy and safety of etelcalcetide. As the only available intravenous calcium-sensing receptor agonist, etelcalcetide is likely to provide a new treatment option for SHPT in haemodialysis patients.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ndt\/gfw408","type":"journal-article","created":{"date-parts":[[2016,10,26]],"date-time":"2016-10-26T07:06:33Z","timestamp":1477465593000},"page":"1723-1730","source":"Crossref","is-referenced-by-count":22,"title":["A phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of etelcalcetide (ONO-5163\/AMG 416), a novel intravenous calcimimetic, for secondary hyperparathyroidism in Japanese haemodialysis patients"],"prefix":"10.1093","volume":"32","author":[{"given":"Masafumi","family":"Fukagawa","sequence":"first","affiliation":[{"name":"1Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine, Isehara, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keitaro","family":"Yokoyama","sequence":"additional","affiliation":[{"name":"2Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Shigematsu","sequence":"additional","affiliation":[{"name":"3Division of Nephrology, Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Akiba","sequence":"additional","affiliation":[{"name":"4Sekikawa Hospital, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akifumi","family":"Fujii","sequence":"additional","affiliation":[{"name":"5Clinical Development Planning"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takuto","family":"Kuramoto","sequence":"additional","affiliation":[{"name":"5Clinical Development Planning"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Motoi","family":"Odani","sequence":"additional","affiliation":[{"name":"6Data Science, Ono Pharmaceutical Co. Ltd, Osaka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tadao","family":"Akizawa","sequence":"additional","affiliation":[{"name":"7Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the ONO-5163 Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2017,1,4]]},"reference":[{"key":"2025102312483970100_gfw408-B1","doi-asserted-by":"crossref","first-page":"913","DOI":"10.2215\/CJN.06040710","article-title":"Secondary hyperparathyroidism: pathogenesis, disease progression, and therapeutic options","volume":"9","author":"Cunningham","year":"2011","journal-title":"Clin J Am Soc 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