{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T12:36:38Z","timestamp":1789648598507,"version":"4.0.0"},"reference-count":25,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"10","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":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["CJASN"],"published-print":{"date-parts":[[2021,10]]},"abstract":"<jats:sec>\n                    <jats:title>Background and objectives<\/jats:title>\n                    <jats:p>Whether iron supplementation in patients on hemodialysis could be delivered by less frequent but higher single doses compared with the currently more common higher-frequency schedules of lower single iron doses is unknown.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design, setting, participants, &amp; measurements<\/jats:title>\n                    <jats:p>\n                      We carried out an open-label, randomized, controlled noninferiority trial over 40 weeks in patients on prevalent hemodialysis (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      =142). We administered in total 2 g iron as 100 mg iron sucrose biweekly in a continuous (20\u2009\u00d7\u2009100 mg) fashion or 500 mg ferric carboxymaltose every 10 weeks in a periodic (4\u2009\u00d7\u2009500 mg) fashion. The primary end point was the change in hemoglobin at week 40 from baseline with a noninferiority margin of \u22120.8 g\/dl. Secondary end points were changes in ferritin, transferrin, transferrin saturation, and erythropoiesis-stimulating agent use.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In total, 108 patients completed the study. At 40 weeks, hemoglobin changed by \u22120.27 g\/dl (95% confidence interval, \u22120.64 to 0.09) in the iron sucrose arm and by \u22120.74 g\/dl (95% confidence interval, \u22121.1 to \u22120.39) in the ferric carboxymaltose arm compared with baseline. Noninferiority was not established in the per-protocol population as hemoglobin changes compared with baseline differed by \u22120.47 g\/dl (95% confidence interval, \u22120.95 to 0.01) in the ferric carboxymaltose arm compared with the iron sucrose arm. Proportional changes from baseline to week 40 differed by \u221231% (98.3% confidence interval, \u221252 to \u22120.1) for ferritin, by 1% (98.3% confidence interval, \u22127 to 10) for transferrin, and by \u221227% (98.3% confidence interval, \u221239 to \u221213) for transferrin saturation in the ferric carboxymaltose arm compared with the iron sucrose arm. Erythropoiesis-stimulating agent dosing did not differ between groups. The overall number of adverse events was similar; however, more infections were observed in the iron sucrose arm.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>An equal cumulative dose of ferric carboxymaltose administered less frequently did not meet noninferiority for maintaining hemoglobin levels compared with iron sucrose administered more frequently.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trial registry name and registration number:<\/jats:title>\n                    <jats:p>Comparison Study of Two Iron Compounds for Treatment of Anemia in Hemodialysis Patients (COPEFER), NCT02198495<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2215\/cjn.03850321","type":"journal-article","created":{"date-parts":[[2021,9,1]],"date-time":"2021-09-01T12:45:20Z","timestamp":1630500320000},"page":"1512-1521","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":6,"title":["Comparison of Iron Dosing Strategies in Patients Undergoing Long-Term Hemodialysis"],"prefix":"10.2215","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct02198495","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02198495","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4491-0562","authenticated-orcid":false,"given":"Bernhard","family":"Bielesz","sequence":"first","affiliation":[{"name":"Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Vienna, 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Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6049-1890","authenticated-orcid":false,"given":"Michael","family":"Wolzt","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8010-7665","authenticated-orcid":false,"given":"Andreas","family":"Gleiss","sequence":"additional","affiliation":[{"name":"Center for Medical Statistics, Informatics, and Intelligent Systems, Institute of Clinical Biometrics, Medical University of Vienna, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Walter H.","family":"H\u00f6rl","sequence":"additional","affiliation":[{"name":"Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Vienna, 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