| The Safety and Tolerability of Ferric Citrate as a Phosphate Binder in Dialysis Patients. | |
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MedLine Citation:
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PMID: 23075669 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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Background: 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. Methods: Enrollment occurred in two periods. Period 1 recruited patients taking 6-15 pills/day of binder with phosphorus of ≥2.5 mg/dl. Period 2 recruited patients taking ≥12 pills/day of binder with phosphorus of ≥3.5 mg/dl. Participants with ferritin ≥1,000 µg/l or transferrin iron saturation (TSAT) ≥50% 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 3.5-5.5 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 µg/l and TSAT <30%. Results: 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 ± 296 µg/l, iron 68 ± 21 µg/dl, and iron saturation 30 ± 7.8%. At the end of study, mean ferritin was 609 ± 340 µg/l (p = 0.02), iron 75 ± 27 µg/dl (p = 0.04), and TSAT was 35 ± 13% (p = 0.001). Mean phosphorus and calcium levels were unchanged from baseline at the end of study. Conclusion: Ferric citrate was well tolerated by patients after 4 weeks with no significant clinical or biochemical adverse events related to exposure. |
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Authors:
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Marvin Sinsakul; Mohammed Sika; Mark Koury; Warren Shapiro; Tom Greene; Jamie Dwyer; Mark Smith; Stephen Korbet; Julia Lewis |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-10-16 |
Journal Detail:
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Title: Nephron. Clinical practice Volume: 121 ISSN: 1660-2110 ISO Abbreviation: Nephron Clin Pract Publication Date: 2012 Oct |
Date Detail:
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Created Date: 2012-10-18 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101159763 Medline TA: Nephron Clin Pract Country: - |
Other Details:
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Languages: ENG Pagination: c25-c29 Citation Subset: - |
Copyright Information:
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Copyright © 2012 S. Karger AG, Basel. |
Affiliation:
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Circle Medical Management, Chicago, Ill., USA. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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