{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,4]],"date-time":"2026-03-04T22:46:35Z","timestamp":1772664395747,"version":"3.50.1"},"reference-count":29,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2016,3,4]],"date-time":"2016-03-04T00:00:00Z","timestamp":1457049600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Hemodialysis International"],"published-print":{"date-parts":[[2016,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p><jats:bold>Introduction<\/jats:bold> Secondary hyperparathyroidism (SHPT) develops in patients with chronic renal failure. Cinacalcet hydrochloride has been used successfully in U.S., Europe, and Japan in the treatment of SHPT, while maintaining serum levels of calcium and phosphorus. The efficacy and safety profile of Cinacalcet treatment <jats:italic>vs<\/jats:italic>. conventional treatments has been of great interest in clinical practice. In this recent phase III study conducted in China, efficacy and safety of a calcimimetic agent, Cinacalcet (Kyowa Hakko Kirin Co., Ltd.), were assessed for SHPT treatment in stable chronic renal disease patients on hemodialysis.\n<\/jats:p><jats:p><jats:bold>Methods<\/jats:bold> In this double\u2010blind, multicenter, placebo\u2010controlled, randomized phase III study, 238 subjects were enrolled in 12 centers and randomly divided into a Cinacalcet group and a placebo group. The percentage of patients achieving a serum parathyroid hormone (PTH) level\u2009\u2264250 pg\/mL was the primary efficacy end point. Serum calcium and phosphorus levels were measured. Adverse events and serious adverse events were recorded, and causal analysis performed.<\/jats:p><jats:p><jats:bold>Findings<\/jats:bold> In primary analysis, 25.4% of the Cinacalcet group and 3.5% of the placebo group achieved the primary end point (PTH\u2009\u2264250 pg\/mL). Calcium and phosphorus levels and calcium\u2013phosphorus product were lower in the Cinacalcet group compared with the placebo group. Eleven serious adverse events were reported and considered to be not related to study drugs. Mild to moderate hypocalcemia and reduced calcium levels were reported and considered to be Cinacalcet related.<\/jats:p><jats:p><jats:bold>Discussion<\/jats:bold> This phase III study demonstrated that Cinacalcet is effective and well tolerated in treating SHPT in Chinese chronic kidney disease patients on hemodialysis, and in a patient population with much higher baseline PTH levels.<\/jats:p>","DOI":"10.1111\/hdi.12410","type":"journal-article","created":{"date-parts":[[2016,3,5]],"date-time":"2016-03-05T17:04:18Z","timestamp":1457197458000},"page":"589-600","source":"Crossref","is-referenced-by-count":13,"title":["Efficacy and safety of Cinacalcet on secondary hyperparathyroidism in Chinese chronic kidney disease patients receiving hemodialysis"],"prefix":"10.1111","volume":"20","author":[{"given":"Changlin","family":"Mei","sequence":"first","affiliation":[{"name":"Shanghai Changzheng Hospital Shanghai 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Medicine Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mei","family":"Wang","sequence":"additional","affiliation":[{"name":"Peking University People's Hospital Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gengru","family":"Jiang","sequence":"additional","affiliation":[{"name":"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xuemei","family":"Li","sequence":"additional","affiliation":[{"name":"Peking Union Medical College Hospital Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fanfan","family":"Hou","sequence":"additional","affiliation":[{"name":"Nanfang Hospital Guangzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Li","family":"Zuo","sequence":"additional","affiliation":[{"name":"Peking University First Hospital Beijing 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