{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T18:54:13Z","timestamp":1790880853819,"version":"4.1.0"},"reference-count":47,"publisher":"S. Karger AG","license":[{"start":{"date-parts":[[2024,9,19]],"date-time":"2024-09-19T00:00:00Z","timestamp":1726704000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2024,9,19]],"date-time":"2024-09-19T00:00:00Z","timestamp":1726704000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Am J Nephrol"],"abstract":"<jats:p>Introduction: Upacicalcet is a novel injectable calcimimetic. This phase 3 multicenter open-label study aimed to assess the long-term efficacy and safety of upacicalcet in hemodialysis (HD) patients with secondary hyperparathyroidism (SHPT). Methods: Japanese HD patients with serum intact parathyroid hormone (iPTH) levels &gt;240 pg\/mL and corrected calcium (cCa) levels \u22658.4 mg\/dL were enrolled. Upacicalcet with a dose range of 25\u2013300 \u00b5g was administered after each dialysis for 52 weeks. The main efficacy endpoint was the percentage of patients achieving the target iPTH level (60\u2013240 pg\/mL). Results: A total of 157 patients were enrolled, of whom 138 completed the study. Overall, 94.2% of patients achieved the target serum iPTH level at week 52. Neither symptomatic hypocalcemia nor cCa level &lt;7.5 mg\/dL occurred despite the negligible increase of concomitant vitamin D receptor activators and calcium carbonate. Upacicalcet improved the control of serum phosphate (P) and calcium levels regardless of baseline PTH levels and decreased intact fibroblast growth factor-23 levels. The largest parathyroid glands shrank, irrespective of their baseline volume or prior calcimimetic usage. Upacicalcet was well tolerated, with no adverse events requiring dose reduction. Conclusion: This is the first study to show that a calcimimetic improves serum P and cCa control without inducing severe hypocalcemia in patients with iPTH levels \u2264300 pg\/mL. Upacicalcet is efficacious in HD patients with mild-to-severe SHPT, with few safety concerns. <\/jats:p>","DOI":"10.1159\/000541493","type":"journal-article","created":{"date-parts":[[2024,9,19]],"date-time":"2024-09-19T16:01:39Z","timestamp":1726761699000},"page":"1-15","source":"Crossref","is-referenced-by-count":3,"title":["Long-Term Efficacy and Safety of Upacicalcet in Japanese Hemodialysis Patients with Secondary Hyperparathyroidism: Open-Label 52-Week Study"],"prefix":"10.1159","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2100-9106","authenticated-orcid":false,"given":"Takayuki","family":"Hamano","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fumihiko","family":"Koiwa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshitaka","family":"Isaka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keitaro","family":"Yokoyama","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masafumi","family":"Fukagawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yosuke","family":"Inagaki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yukihisa S.","family":"Watanabe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daisuke","family":"Honda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tadao","family":"Akizawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"127","published-online":{"date-parts":[[2024,9,19]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.2215\/cjn.06040710"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.1007\/s10157-016-1369-2"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.1111\/1744-9987.12772"},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.12688\/f1000research.22636.1"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.1038\/sj.ki.5000414"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.1097\/01.asn.0000133041.27682.a2"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.1681\/asn.v1341017"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.1093\/ndt\/gfm534"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.1056\/nejmoa031633"},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-200948050-00002"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.cd006254.pub2"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.1111\/j.1542-4758.2009.00397.x"},{"key":"ref13","doi-asserted-by":"publisher","DOI":"10.1016\/j.kint.2018.05.013"},{"key":"ref14","doi-asserted-by":"publisher","DOI":"10.1111\/1744-9987.13434"},{"key":"ref15","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2016.19456"},{"key":"ref16","doi-asserted-by":"publisher","DOI":"10.1093\/ndt\/gfz111"},{"key":"ref17","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2016.19468"},{"key":"ref18","doi-asserted-by":"publisher","DOI":"10.1053\/j.ajkd.2020.02.439"},{"key":"ref19","doi-asserted-by":"publisher","DOI":"10.1007\/s10157-017-1442-5"},{"key":"ref20","doi-asserted-by":"publisher","DOI":"10.1093\/ndt\/gfad213"},{"key":"ref21","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-021-01578-y"},{"key":"ref22","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-022-01139-w"},{"key":"ref23","doi-asserted-by":"publisher","DOI":"10.2215\/cjn.0000000000000253"},{"key":"ref24","doi-asserted-by":"publisher","DOI":"10.1159\/000156717"},{"key":"ref25","doi-asserted-by":"publisher","DOI":"10.1111\/1744-9987.12058"},{"key":"ref26","doi-asserted-by":"publisher","DOI":"10.1186\/s12882-021-02482-z"},{"key":"ref27","doi-asserted-by":"publisher","DOI":"10.1007\/s00223-008-9127-4"},{"key":"ref28","doi-asserted-by":"publisher","DOI":"10.1016\/j.lfs.2005.02.007"},{"key":"ref29","doi-asserted-by":"publisher","DOI":"10.1681\/asn.2014101009"},{"key":"ref30","doi-asserted-by":"publisher","DOI":"10.1681\/asn.2019101106"},{"key":"ref31","doi-asserted-by":"publisher","DOI":"10.1056\/nejmoa0706130"},{"key":"ref32","doi-asserted-by":"publisher","DOI":"10.1161\/circulationaha.114.013876"},{"key":"ref33","doi-asserted-by":"publisher","DOI":"10.1111\/j.1744-9987.2007.00489.x"},{"key":"ref34","doi-asserted-by":"publisher","DOI":"10.1159\/000188261"},{"key":"ref35","doi-asserted-by":"publisher","DOI":"10.1111\/j.1744-9987.2006.00364.x"},{"key":"ref36","doi-asserted-by":"publisher","DOI":"10.2215\/cjn.02110310"},{"key":"ref37","doi-asserted-by":"publisher","DOI":"10.1111\/1744-9987.12292"},{"key":"ref38","doi-asserted-by":"publisher","DOI":"10.1016\/j.ekir.2021.08.020"},{"key":"ref39","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1001436"},{"key":"ref40","doi-asserted-by":"publisher","DOI":"10.1080\/17446651.2020.1780911"},{"key":"ref41","doi-asserted-by":"publisher","DOI":"10.1007\/s10741-013-9371-1"},{"key":"ref42","doi-asserted-by":"publisher","DOI":"10.1016\/j.mayocp.2017.05.028"},{"key":"ref43","doi-asserted-by":"publisher","DOI":"10.1111\/1744-9987.12030"},{"key":"ref44","doi-asserted-by":"publisher","DOI":"10.1053\/j.ajkd.2017.07.019"},{"key":"ref45","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.460"},{"key":"ref46","doi-asserted-by":"publisher","DOI":"10.1016\/j.ekir.2020.09.010"},{"key":"ref47","doi-asserted-by":"publisher","DOI":"10.1161\/01.res.0000141775.67189.98"}],"container-title":["American Journal of Nephrology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/karger.com\/ajn\/article-pdf\/doi\/10.1159\/000541493\/4293498\/000541493.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/karger.com\/ajn\/article-pdf\/doi\/10.1159\/000541493\/4293498\/000541493.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,23]],"date-time":"2025-04-23T14:50:12Z","timestamp":1745419812000},"score":1,"resource":{"primary":{"URL":"https:\/\/karger.com\/article\/doi\/10.1159\/000541493"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,9,19]]},"references-count":47,"URL":"https:\/\/doi.org\/10.1159\/000541493","archive":["Portico"],"relation":{"is-supplemented-by":[{"id-type":"doi","id":"10.6084\/m9.figshare.27060127","asserted-by":"subject"}]},"ISSN":["0250-8095","1421-9670"],"issn-type":[{"value":"0250-8095","type":"print"},{"value":"1421-9670","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,9,19]]}}}