{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,5]],"date-time":"2026-03-05T23:35:21Z","timestamp":1772753721392,"version":"3.50.1"},"reference-count":10,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2014,11,3]],"date-time":"2014-11-03T00:00:00Z","timestamp":1414972800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Ther Apher Dial"],"published-print":{"date-parts":[[2015,6]]},"abstract":"Abstract<\/jats:title>Secondary hyperparathyroidism (SHPT<\/jats:styled-content>) is one of the major complications of chronic kidney disease (CKD<\/jats:styled-content>) and is associated with elevated serum intact parathyroid hormone (iPTH<\/jats:styled-content>). Calcitriol, a non\u2010selective vitamin D<\/jats:styled-content> receptor agonist (VDRA<\/jats:styled-content>) that suppresses iPTH<\/jats:styled-content> is used for SHPT<\/jats:styled-content> treatment, but its use is frequently complicated by hypercalcemia. Paricalcitol, a selective VDRA<\/jats:styled-content>, demonstrated efficacy in iPTH suppression compared to maxacalcitol in a Phase 2 study (M<\/jats:styled-content>11\u2010609) in J<\/jats:styled-content>apanese subjects. The current larger P<\/jats:styled-content>hase 3 study (M<\/jats:styled-content>11\u2010517), evaluated the efficacy of intravenous paricalcitol injection compared to intravenous maxacalcitol injection with respect to iPTH<\/jats:styled-content> and calcium control using a non\u2010inferiority primary endpoint. In this double\u2010blind, double\u2010dummy, parallel\u2010group study, eligible J<\/jats:styled-content>apanese CKD<\/jats:styled-content> subjects with SHPT<\/jats:styled-content> on hemodialysis were randomized 1:1 to receive intravenous paricalcitol or intravenous maxacalcitol injections for 12 weeks. Dynamic allocation of subjects on the basis of screening iPTH<\/jats:styled-content> levels was used to ensure equal distribution of subjects with iPTH<\/jats:styled-content>\u2009<500\u2009pg\/mL and \u2265500\u2009pg\/mL into the two treatment groups. 255 subjects were randomized to receive paricalcitol (N<\/jats:italic>\u2009=\u2009127) or maxacalcitol (N<\/jats:italic>\u2009=\u2009128). Primary efficacy analysis indicated that 27.7% in the paricalcitol group vs. 30.5% in the maxacalcitol group (95% CI<\/jats:styled-content> \u221214.34% to 8.79%, P<\/jats:italic>\u2009=\u20090.353) achieved target iPTH<\/jats:styled-content> in the last 3 weeks without hypercalcemia during treatment, failing to achieve the non\u2010inferiority margin of \u22125% that was set based upon agreement with the PMDA<\/jats:styled-content>. Both intravenous paricalcitol and maxacalcitol were effective in reducing iPTH<\/jats:styled-content> and provided similar safety profiles; however, non\u2010inferiority for paricalcitol vs. maxacalcitol was not demonstrated.<\/jats:p>","DOI":"10.1111\/1744-9987.12242","type":"journal-article","created":{"date-parts":[[2014,11,3]],"date-time":"2014-11-03T09:50:20Z","timestamp":1415008220000},"page":"225-234","source":"Crossref","is-referenced-by-count":12,"title":["Comparison of P<\/scp>aricalcitol With M<\/scp>axacalcitol Injection in J<\/scp>apanese Hemodialysis Patients With Secondary Hyperparathyroidism"],"prefix":"10.1111","volume":"19","author":[{"given":"Tadao","family":"Akizawa","sequence":"first","affiliation":[{"name":"Showa University School of Medicine Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takashi","family":"Akiba","sequence":"additional","affiliation":[{"name":"Tokyo Women's Medical University Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hideki","family":"Hirakata","sequence":"additional","affiliation":[{"name":"Japanese Red Cross Fukuoka Hospital Fukuoka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eriko","family":"Kinugasa","sequence":"additional","affiliation":[{"name":"Showa University Northern Yokohama Hospital Yokohama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoshihiro","family":"Tominaga","sequence":"additional","affiliation":[{"name":"Nagoya Daini Red Cross Hospital Aichi Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masafumi","family":"Fukagawa","sequence":"additional","affiliation":[{"name":"Tokai University School of Medicine Isehara Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Keitaro","family":"Yokoyama","sequence":"additional","affiliation":[{"name":"Jikei University School of Medicine Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wuyan","family":"Zhang","sequence":"additional","affiliation":[{"name":"Clinical Statistics AbbVie North Chicago IL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter G.","family":"Linde","sequence":"additional","affiliation":[{"name":"Renal Clinical Development AbbVie North Chicago IL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masashi","family":"Suzuki","sequence":"additional","affiliation":[{"name":"Shinrakuen Hospital Niigata Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2014,11,3]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1152\/ajprenal.00302.2004"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-200767140-00003"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa022536"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1523-1755.2003.00878.x"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1053\/ajkd.2001.28110"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/ndt\/17.suppl_10.10"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1093\/ndt\/17.suppl_10.41"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1172\/JCI114229"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1093\/ndt\/17.suppl_10.20"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/1744-9987.12058"}],"container-title":["Therapeutic Apheresis and Dialysis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2F1744-9987.12242","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/1744-9987.12242","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,24]],"date-time":"2023-09-24T16:18:08Z","timestamp":1695572288000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/1744-9987.12242"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2014,11,3]]},"references-count":10,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2015,6]]}},"alternative-id":["10.1111\/1744-9987.12242"],"URL":"https:\/\/doi.org\/10.1111\/1744-9987.12242","archive":["Portico"],"relation":{},"ISSN":["1744-9979","1744-9987"],"issn-type":[{"value":"1744-9979","type":"print"},{"value":"1744-9987","type":"electronic"}],"subject":[],"published":{"date-parts":[[2014,11,3]]}}}