{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,6]],"date-time":"2026-06-06T15:54:41Z","timestamp":1780761281170,"version":"3.54.1"},"reference-count":18,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2018,4,15]],"date-time":"2018-04-15T00:00:00Z","timestamp":1523750400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100006484","name":"Vifor Pharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100006484","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Hemodialysis International"],"published-print":{"date-parts":[[2018,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:label\/><jats:p><jats:bold>Introduction:<\/jats:bold> Sucroferric oxyhydroxide (SFOH) is a non\u2010calcium, iron\u2010based phosphate binder that demonstrated sustained serum phosphorus (sP) control, good tolerability, and lower pill burden, vs. sevelamer carbonate (\u201csevelamer\u201d), in a Phase 3 study conducted in dialysis patients with hyperphosphatemia. This analysis evaluates the efficacy and safety of SFOH and sevelamer among African American (AA) patients participating in the trial.<\/jats:p><jats:p><jats:bold>Methods:<\/jats:bold> Post hoc analysis of a 24\u2010week, Phase 3, open\u2010label trial (NCT01324128) and its 28\u2010week extension study (NCT01464190). Patients were randomized 2:1 to SFOH (1.0\u20133.0 g\/day) or sevelamer (2.4\u221214.4 g\/day) for up to 52 weeks.<\/jats:p><jats:p><jats:bold>Findings:<\/jats:bold> Of 549 patients who completed the Phase 3 study and extension, 100 (18.2%) AA patients were eligible for efficacy analysis (SFOH, n\u2009=\u200948; sevelamer, n\u2009=\u200952). sP concentrations decreased rapidly and comparably with both treatments by Week 8 (mean\u2009\u00b1\u2009standard deviation change from baseline: \u22121.9\u2009\u00b1\u20091.9 mg\/dL for SFOH and \u22122.2\u2009\u00b1\u20091.8 mg\/dL for sevelamer). These reductions were maintained for 52 weeks (\u22122.1\u2009\u00b1\u20092.6 and \u22122.1\u2009\u00b1\u20091.6 mg\/dL) and achieved with a lower mean pill burden (3.4\u2009\u00b1\u20091.4 vs. 7.6\u2009\u00b1\u20092.9 tablets\/day) with SFOH vs. sevelamer. Treatment adherence rates (adherence within 70%\u2013120% of expected medication intake) were 79.2% with SFOH and 59.6% with sevelamer. The proportion of patients reporting serious adverse events (AEs) was 27.7% with SFOH and 30.7% with sevelamer. More patients withdrew due to treatment\u2010emergent AEs with SFOH vs. sevelamer (18.5% vs. 8.0%). The most common AEs with both treatments were gastrointestinal\u2010related: diarrhea and discolored feces with SFOH, and nausea, vomiting, and constipation with sevelamer.<\/jats:p><jats:p><jats:bold>Discussion:<\/jats:bold> SFOH is an efficacious and well\u2010tolerated treatment for hyperphosphatemia in AA dialysis patients, with a lower pill burden and an improved adherence rate vs. sevelamer. These findings were consistent with the wider US patient population and the overall study population.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hdi.12663","type":"journal-article","created":{"date-parts":[[2018,4,15]],"date-time":"2018-04-15T22:34:33Z","timestamp":1523831673000},"page":"480-491","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Long\u2010term efficacy and safety of sucroferric oxyhydroxide in African American dialysis patients"],"prefix":"10.1111","volume":"22","author":[{"given":"Stuart M.","family":"Sprague","sequence":"first","affiliation":[{"name":"NorthShore University HealthSystem Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Markus","family":"Ketteler","sequence":"additional","affiliation":[{"name":"Coburg Clinic and KfH\u2010Dialysis Center Coburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adrian C.","family":"Covic","sequence":"additional","affiliation":[{"name":"\u2018Gr.T. Popa\u2019 University of Medicine and Pharmacy Iasi Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00fcrgen","family":"Floege","sequence":"additional","affiliation":[{"name":"RWTH University Hospital Aachen Aachen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Viatcheslav","family":"Rakov","sequence":"additional","affiliation":[{"name":"Vifor Pharma Glattbrugg Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sebastian","family":"Walpen","sequence":"additional","affiliation":[{"name":"Vifor Pharma Glattbrugg Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anjay","family":"Rastogi","sequence":"additional","affiliation":[{"name":"University of California Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,4,15]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrneph.2011.112"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.ajkd.2010.11.028"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1093\/ndt\/gft514"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1167\/iovs.03-0121"},{"key":"e_1_2_6_6_1","unstructured":"Centers for Disease Control and Prevention. Chronic Kidney Disease Surveillance System\u2014United States.Crude Prevalence of CKD Stages 1\u20134. National Health and Nutrition Examination Survey. Available from:https:\/\/nccd.cdc.gov\/ckd\/detail.aspx?QNum=Q9&Strat=Race%2fEthnicity(accessed date: November 2017)."},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2012070713"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0706130"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2010121224"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1159\/000438999"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.2011.626768"},{"key":"e_1_2_6_12_1","unstructured":"Fresenius Medical Care North America.VELPHORO\u00ae (sucroferric oxyhydroxide) chewable tablet for oral use. Highlights of prescribing information 2014. Available from:http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2014\/205109s001lbl.pdf(accessed date: June 22 2016)."},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1038\/ki.2014.58"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1093\/ndt\/gfv006"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.5414\/CN109021"},{"key":"e_1_2_6_16_1","first-page":"576A","article-title":"Improved serum phosphorus control and decreased phosphate binder pill burden amongst African American hemodialysis patients taking sucroferric oxyhydroxide","volume":"26","author":"Ficociello L","year":"2015","journal-title":"J Am Soc Nephrol."},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1159\/000356394"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2014020218"},{"key":"e_1_2_6_19_1","first-page":"1330","article-title":"Iron\u2010related parameters in dialysis patients treated with sucroferric oxyhydroxide","volume":"32","author":"Covic AC","year":"2017","journal-title":"Nephrol Dial Transplant."}],"container-title":["Hemodialysis International"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fhdi.12663","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/hdi.12663","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,16]],"date-time":"2023-09-16T06:27:39Z","timestamp":1694845659000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/hdi.12663"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,4,15]]},"references-count":18,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2018,10]]}},"alternative-id":["10.1111\/hdi.12663"],"URL":"https:\/\/doi.org\/10.1111\/hdi.12663","archive":["Portico"],"relation":{},"ISSN":["1492-7535","1542-4758"],"issn-type":[{"value":"1492-7535","type":"print"},{"value":"1542-4758","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,4,15]]},"assertion":[{"value":"2017-11-27","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-04-15","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}