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However, available PBs have limitations, including unfavorable tolerability and safety.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This phase 3, multicenter, randomized, open-label study investigated safety and efficacy of sucroferric oxyhydroxide (SFOH) in pediatric and adolescent subjects with CKD and hyperphosphatemia. Subjects were randomized to SFOH or calcium acetate (CaAc) for a 10-week dose titration (stage 1), followed by a 24-week safety extension (stage 2). Primary efficacy endpoint was change in serum phosphorus from baseline to the end of stage 1 in the SFOH group. Safety endpoints included treatment-emergent adverse events (TEAEs).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Eighty-five subjects (2\u201318\u00a0years) were randomized and treated (SFOH, <jats:italic>n<\/jats:italic>\u00a0=\u200966; CaAc, <jats:italic>n<\/jats:italic>\u00a0=\u200919). Serum phosphorus reduction from baseline to the end of stage 1 in the overall SFOH group (least squares [LS] mean \u00b1 standard error [SE]) was \u2212\u20090.488\u2009\u00b1\u20090.186\u00a0mg\/dL; <jats:italic>p<\/jats:italic>\u00a0=\u20090.011 (post hoc analysis). Significant reductions in serum phosphorus were observed in subjects aged \u2265\u200912 to \u2264\u200918\u00a0years (LS mean \u00b1 SE \u2212\u20090.460\u2009\u00b1\u20090.195\u00a0mg\/dL; <jats:italic>p<\/jats:italic>\u00a0=\u20090.024) and subjects with serum phosphorus above age-related normal ranges at baseline (LS mean \u00b1 SE \u2212\u20090.942\u2009\u00b1\u20090.246\u00a0mg\/dL; <jats:italic>p<\/jats:italic>\u00a0=\u20090.005). Similar proportions of subjects reported \u2265\u20091 TEAE in the SFOH (75.8%) and CaAc (73.7%) groups. Withdrawal due to TEAEs was more common with CaAc (31.6%) than with SFOH (18.2%).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>SFOH effectively managed serum phosphorus in pediatric patients with a low pill burden and a safety profile consistent with that reported in adult patients.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s00467-020-04805-y","type":"journal-article","created":{"date-parts":[[2020,10,27]],"date-time":"2020-10-27T03:03:00Z","timestamp":1603767780000},"page":"1233-1244","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Safety and efficacy of sucroferric oxyhydroxide in pediatric patients with chronic kidney disease"],"prefix":"10.1007","volume":"36","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2490-021X","authenticated-orcid":false,"given":"Larry A.","family":"Greenbaum","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nikola","family":"Jeck","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G\u00fcnter","family":"Klaus","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc","family":"Fila","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristina","family":"Stoica","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sahar","family":"Fathallah-Shaykh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana","family":"Paredes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Larysa","family":"Wickman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raoul","family":"Nelson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rita D.","family":"Swinford","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0984-3771","authenticated-orcid":false,"given":"Carolyn Larkins","family":"Abitbol","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mihaela","family":"Balgradean","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7767-2102","authenticated-orcid":false,"given":"Augustina","family":"Jankauskiene","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amandine","family":"Perrin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Milica","family":"Enoiu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5571-6901","authenticated-orcid":false,"given":"Sun-Young","family":"Ahn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,10,27]]},"reference":[{"key":"4805_CR1","doi-asserted-by":"publisher","first-page":"148","DOI":"10.1038\/ki.2008.130","volume":"74","author":"KA Hruska","year":"2008","unstructured":"Hruska KA, Mathew S, Lund R, Qiu P, Pratt R (2008) Hyperphosphatemia of chronic kidney disease. 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