{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,19]],"date-time":"2026-03-19T12:01:01Z","timestamp":1773921661971,"version":"3.50.1"},"reference-count":6,"publisher":"S. Karger AG","issue":"1-2","license":[{"start":{"date-parts":[[2012,10,16]],"date-time":"2012-10-16T00:00:00Z","timestamp":1350345600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.karger.com\/Services\/SiteLicenses"},{"start":{"date-parts":[[2012,10,16]],"date-time":"2012-10-16T00:00:00Z","timestamp":1350345600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.karger.com\/Services\/SiteLicenses"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Nephron Clin Pract"],"abstract":"<b><i>Background:<\/i><\/b> A phase II open-label study was conducted in hemodialysis patients evaluating the short-term safety, tolerability, and iron absorption with ferric citrate when used as a phosphate binder. <b><i>Methods:<\/i><\/b> Enrollment occurred in two periods. Period 1 recruited patients taking 6\u201315 pills\/day of binder with phosphorus of \u22652.5 mg\/dl. Period 2 recruited patients taking \u226512 pills\/day of binder with phosphorus of \u22653.5 mg\/dl. Participants with ferritin \u22651,000 \u00b5g\/l or transferrin iron saturation (TSAT) \u226550% at screening were excluded. Subjects discontinued their previous binders and started 4.5 g\/day of ferric citrate (period 1) or 6 g\/day (period 2) and were titrated for 4 weeks to maintain a phosphorus of 3.5\u20135.5 mg\/dl. Chemistries and complete blood count were obtained weekly and a gastrointestinal questionnaire was administered at drug initiation and final visit. Iron therapy was permitted if the ferritin was <500 \u00b5g\/l and TSAT <30%. <b><i>Results:<\/i><\/b> Fifty-five subjects were enrolled. Four serious adverse events were reported; none were related to the study drug. Findings from the gastrointestinal questionnaire included stool discoloration (69%), constipation (15%), and bloating (7%). Mean iron parameters at the beginning of the study were ferritin 554 \u00b1 296 \u00b5g\/l, iron 68 \u00b1 21 \u00b5g\/dl, and iron saturation 30 \u00b1 7.8%. At the end of study, mean ferritin was 609 \u00b1 340 \u00b5g\/l (p = 0.02), iron 75 \u00b1 27 \u00b5g\/dl (p = 0.04), and TSAT was 35 \u00b1 13% (p = 0.001). Mean phosphorus and calcium levels were unchanged from baseline at the end of study. <b><i>Conclusion:<\/i><\/b> Ferric citrate was well tolerated by patients after 4 weeks with no significant clinical or biochemical adverse events related to exposure.<\/jats:p>","DOI":"10.1159\/000341922","type":"journal-article","created":{"date-parts":[[2012,10,19]],"date-time":"2012-10-19T15:40:39Z","timestamp":1350661239000},"page":"c25-c29","source":"Crossref","is-referenced-by-count":45,"title":["The Safety and Tolerability of Ferric Citrate as a Phosphate Binder in Dialysis Patients"],"prefix":"10.1159","volume":"121","author":[{"given":"Marvin","family":"Sinsakul","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mohammed","family":"Sika","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"Koury","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Warren","family":"Shapiro","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tom","family":"Greene","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jamie","family":"Dwyer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"Smith","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen","family":"Korbet","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julia","family":"Lewis","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"for the Collaborative Study Group","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"127","published-online":{"date-parts":[[2012,10,16]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.1038%2Fki.2009.60"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.1053%2Fajkd.1998.v31.pm9531176"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.2215%2FCJN.04100609"},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.1146%2Fannurev.nutr.24.012003.132306"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.1093%2Fndt%2F17.2.265"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.1111%2Fj.1523-1755.2004.09005.x"}],"container-title":["Nephron Clinical Practice"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.karger.com\/Article\/Pdf\/341922","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.karger.com\/Article\/Pdf\/341922","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,23]],"date-time":"2025-04-23T18:42:33Z","timestamp":1745433753000},"score":1,"resource":{"primary":{"URL":"https:\/\/karger.com\/article\/doi\/10.1159\/000341922"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2012,10,16]]},"references-count":6,"journal-issue":{"issue":"1-2","published-online":{"date-parts":[[2012,12,1]]},"published-print":{"date-parts":[[2012,12,14]]}},"URL":"https:\/\/doi.org\/10.1159\/000341922","archive":["Portico"],"relation":{},"ISSN":["1660-2110"],"issn-type":[{"value":"1660-2110","type":"electronic"}],"subject":[],"published":{"date-parts":[[2012,10,16]]}}}