{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T14:16:32Z","timestamp":1789395392155,"version":"build-2803163510"},"reference-count":34,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2020,2,12]],"date-time":"2020-02-12T00:00:00Z","timestamp":1581465600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Pharmacosmos A\/S"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,1,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>The optimal intravenous (IV) iron would allow safe correction of iron deficiency at a single infusion over a short time. The FERWON-NEPHRO trial evaluated the safety and efficacy of iron isomaltoside 1000\/ferric derisomaltose (IIM) in patients with non-dialysis-dependent chronic kidney disease and iron deficiency anaemia.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In this randomized, open-label and multi-centre trial conducted in the USA, patients were randomized 2:1 to a single dose of 1000\u2009mg IIM or iron sucrose (IS) administered as 200\u2009mg IV injections up to five times within a 2-week period. The co-primary endpoints were serious or severe hypersensitivity reactions and change in haemoglobin (Hb) from baseline to Week 8. Secondary endpoints included incidence of composite cardiovascular adverse events (AEs).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>A total of 1538 patients were enrolled (mean estimated glomerular filtration rate 35.5\u2009mL\/min\/1.73\u2009m2). The co-primary safety objective was met based on no significant difference in the incidence of serious or severe hypersensitivity reactions in the IIM and IS groups [0.3% versus 0%; risk difference: 0.29% (95% confidence interval: \u20130.19; 0.77; P\u2009&amp;gt;\u20090.05)]. Incidence of composite cardiovascular AEs was significantly lower in the IIM versus IS group (4.1% versus 6.9%; P\u2009=\u20090.025). Compared with IS, IIM led to a more pronounced increase in Hb during the first 4\u2009weeks (P\u2009\u2264\u20090.021), and change in Hb to Week 8 showed non-inferiority, confirming that the co-primary efficacy objective was met.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Compared with multiple doses of IS, a single dose of IIM induced a non-inferior 8-week haematological response, comparably low rates of hypersensitivity reactions, and a significantly lower incidence of composite cardiovascular AEs.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ndt\/gfaa011","type":"journal-article","created":{"date-parts":[[2020,1,10]],"date-time":"2020-01-10T12:13:02Z","timestamp":1578658382000},"page":"111-120","source":"Crossref","is-referenced-by-count":85,"title":["Safety and efficacy of\u00a0iron isomaltoside 1000\/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial"],"prefix":"10.1093","volume":"36","author":[{"given":"Sunil","family":"Bhandari","sequence":"first","affiliation":[{"name":"Department of Renal Medicine, Hull University Teaching Hospitals NHS Trust, Kingston upon Hull, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip A","family":"Kalra","sequence":"additional","affiliation":[{"name":"Department of Renal Medicine, Salford Royal NHS Foundation Trust, Salford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mario","family":"Berkowitz","sequence":"additional","affiliation":[{"name":"Leon Medical Research, Miami, FL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diogo","family":"Belo","sequence":"additional","affiliation":[{"name":"California Institute of Renal Research, Chula Vista, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lars L","family":"Thomsen","sequence":"additional","affiliation":[{"name":"Department of Clinical and Non-clinical Research, Pharmacosmos A\/S, Holbaek, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Myles","family":"Wolf","sequence":"additional","affiliation":[{"name":"Division of Nephrology, Department of Medicine, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2020,2,12]]},"reference":[{"key":"2020122916295401900_gfaa011-B1","doi-asserted-by":"crossref","first-page":"67","DOI":"10.1186\/s12882-018-0861-1","article-title":"Prevalence, treatment patterns, and healthcare resource utilization in Medicare and commercially insured non-dialysis-dependent chronic kidney disease patients with and without anemia in the United States","volume":"19","author":"St Peter","year":"2018","journal-title":"BMC Nephrol"},{"key":"2020122916295401900_gfaa011-B2","doi-asserted-by":"crossref","first-page":"1320","DOI":"10.2337\/dc08-0779","article-title":"Anemia, diabetes, and chronic kidney disease","volume":"32","author":"Mehdi","year":"2009","journal-title":"Diabetes Care"},{"key":"2020122916295401900_gfaa011-B3","first-page":"279","article-title":"KDIGO Clinical Practice Guideline for Anemia in Chronic Kidney Disease","volume":"2","year":"2012","journal-title":"Kidney Int Suppl"},{"key":"2020122916295401900_gfaa011-B4"},{"key":"2020122916295401900_gfaa011-B5","doi-asserted-by":"crossref","first-page":"2436","DOI":"10.1056\/NEJMoa0908355","article-title":"Ferric carboxymaltose in patients with heart failure and iron deficiency","volume":"361","author":"Anker","year":"2009","journal-title":"N Engl J Med"},{"key":"2020122916295401900_gfaa011-B6","doi-asserted-by":"crossref","first-page":"657","DOI":"10.1093\/eurheartj\/ehu385","article-title":"Beneficial effects of long-term intravenous iron therapy with ferric carboxymaltose in patients with symptomatic heart failure and iron deficiency","volume":"36","author":"Ponikowski","year":"2015","journal-title":"Eur Heart J"},{"key":"2020122916295401900_gfaa011-B7","doi-asserted-by":"crossref","first-page":"786","DOI":"10.1002\/ejhf.473","article-title":"Effects of intravenous iron therapy in iron-deficient patients with systolic heart failure: a meta-analysis of randomized controlled trials","volume":"18","author":"Jankowska","year":"2016","journal-title":"Eur J Heart Fail"},{"key":"2020122916295401900_gfaa011-B8","doi-asserted-by":"crossref","first-page":"131","DOI":"10.1111\/j.1778-428X.2010.01145.x","article-title":"Effects of administration of iron isomaltoside 1000 in patients with chronic heart failure. 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