{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T21:41:23Z","timestamp":1790890883952,"version":"4.1.0"},"reference-count":19,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2017,3,1]],"date-time":"2017-03-01T00:00:00Z","timestamp":1488326400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"ClinicalTrials.gov","award":["NCT01850602"],"award-info":[{"award-number":["NCT01850602"]}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Nephrology"],"published-print":{"date-parts":[[2017,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>We aimed to investigate the non\u2010inferiority of PA21 (sucroferric oxyhydroxide) to sevelamer hydrochloride (sevelamer) in terms of efficacy and safety in Japanese haemodialysis patients with hyperphosphataemia.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this Phase III, open\u2010label, multicentre study, 213 haemodialysis patients with hyperphosphataemia were randomized to PA21 or sevelamer treatment for 12\u2009weeks. The primary outcome was adjusted serum phosphorus concentration at the end of treatment; the non\u2010inferiority of PA21 was confirmed if the upper limit of the two\u2010sided 95% confidence interval (CI) is \u22640.32\u2009mmol\/L. Secondary outcomes were corrected serum calcium and intact\u2010parathyroid hormone concentrations. Adverse events (AEs) and adverse drug reactions (ADRs) were evaluated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The adjusted mean serum phosphorus concentration at the end of treatment confirmed the non\u2010inferiority of PA21 for lowering serum phosphorus compared with sevelamer (1.62 vs 1.72\u2009mmol\/L; difference, \u22120.11\u2009mmol\/L; 95% CI, \u22120.20 to \u22120.02\u2009mmol\/L). The mean daily tablet intake was 5.6\u2009\u00b1\u20092.6 and 18.7\u2009\u00b1\u20097.1 tablets in the PA21 and sevelamer groups, respectively. The incidences of AEs and ADRs were not significantly different between the two groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The non\u2010inferiority of PA21 to sevelamer was confirmed for the treatment of Japanese haemodialysis patients with hyperphosphataemia. PA21 was effective, safe, and well tolerated, while having a considerably lower pill burden than sevelamer.<\/jats:p><\/jats:sec>","DOI":"10.1111\/nep.12891","type":"journal-article","created":{"date-parts":[[2016,8,6]],"date-time":"2016-08-06T11:41:27Z","timestamp":1470483687000},"page":"293-300","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":44,"title":["Efficacy and safety of sucroferric oxyhydroxide compared with sevelamer hydrochloride in Japanese haemodialysis patients with hyperphosphataemia: A randomized, open\u2010label, multicentre, 12\u2010week phase III study"],"prefix":"10.1111","volume":"22","author":[{"given":"Fumihiko","family":"Koiwa","sequence":"first","affiliation":[{"name":"Division of Nephrology, Department of Medicine Showa University Fujigaoka Hospital  Yokohama 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