@article{3774efffc0be48a0bf8b6234bf666ece,
title = "Sodium ferric gluconate complex in haemodialysis patients: A prospective evaluation of long-term safety",
abstract = "Background. A previous single dose placebo-controlled double-blinded trial showed an extremely low (0.4%) intolerance rate of sodium ferric gluconate complex (SFGC) in SFGC-naive haemodialysis patients. No large prospective trials have assessed the safety of SFGC during repeated exposure in the outpatient haemodialysis setting. Methods. Chronic haemodialysis patients completing the single-dose trial of SFGC were eligible to participate in this prospective, multicentre, open-label, long-term evaluation of SFGC, designed to record adverse events occurring up to 72 h post-dose. Patients received as many as 20 ampules (1250mg total) of SFGC at an investigator-determined dose and rate over a 9 month evaluation period. Results. Among 1412 enrolled patients at 54 centres, 1321 received 13 151 infusions of SFGC. Most doses (94.8%) were ≤125 mg and the majority were given over 10 min. Infusion rates ranged from <5 to 125 mg/min. There were no life-threatening events. Fifty-one patients (3.9%) experienced an adverse event, possibly related to SFGC. Of these, one experienced a serious event (hypotension). Five patients (0.4%) experienced an event that precluded SFGC readministration: pruritus (three), vasodilatation (one) and loss of taste (one). Among 372 patients (28.2%) receiving angiotensin-converting enzyme inhibitor (ACEI) therapy, adverse events were neither more common nor more severe than in the other patients. Conclusions. Repeated doses of SFGC are very well tolerated in haemodialysis patients. No life-threatening events were observed in over 13 000 doses administered. Administration of SFGC to patients using ACEI is safe and does not increase the incidence or severity of adverse events to SFGC.",
keywords = "Haemodialysis, Intravenous iron, Iron deficiency, Iron dextran sensitivity, Sodium ferric gluconate complex",
author = "Beckie Michael and Coyne, {Daniel W.} and Folkert, {Vaughn W.} and Dahl, {Naomi V.} and Warnock, {David G.}",
note = "Funding Information: Acknowledgements. The additional participating investigators were Rajiv Agarwal, MD, Indiana University, Indianapolis, IN; Raul Balagtas, MD, Tampa, FL; Daniel C. Batlle, MD, Northwestern University Medical School, Chicago, IL; Jeffrey Berns, MD, University of Pennsylvania; Jose Cangiano, MD, San Juan Bautista School of Medicine, San Juan, Puerto Rico; Laura Dember, MD, Boston University Medical Center; Devasmita Dev, MD, Veterans Administration North Texas Health Care; Jorge Diego, MD, University of Miami, Miami, FL; Joseph W. Eschbach, MD, Northwest Kidney Center, Seattle, WA; Stephen Z. Fadem, MD, Houston Kidney Center, Houston, TX; Steven Fishbane, MD, Winthrop University Hospital, Mineola, NY; Mary Gellens, MD, St Louis University Medical College; Michael Germain, MD, West Springfield, MA; Charles Graeber, MD, Newington, CT; Mandeep Grewal, MD, Chattanooga, TN; Louisa Ho, MD, Evanston, IL; Onyekachi Ifudu, MD, State University of New York; Dennis Imperio, MD, Sarasota, FL; Sam James, MD, University of Arizona Medical Center; Mark Kaplan, MD, Nashville, TN; Ellie Kelepouris, MD, Temple University School of Medicine; Ken Kleinman, MD, University of California at Los Angeles; David Leehey, MD, Loyola University Medical Center; Jill Lindberg, MD, New Orleans, LA; Robert Lynn, MD, Bronx Dialysis Center, New York City, NY; Thomas Marbury, MD, Orlando, FL; Ronald Mars, MD, University of Florida; Allen R. Nissenson, MD, UCLA School of Medicine, Los Angeles, CA; Chamberlain Obialo, MD, Morehouse School of Medicine, Atlanta, GA; Chika Oguagha, MD, Nephrology Foundation of Brooklyn, New York City, NY; Walter Piering, MD, Medical College of Wisconsin; Rasib Raja, MD, Albert Einstein Medical Center, Philadelphia, PA; Steven Rosenblatt, MD, San Antonio Kidney Diseases Center, San Antonio, TX; Jeff Sands, MD, Emory University; Steve Schwab, MD, Duke University Medical Center South; Allan Schwartz, MD, Hahnemann University Hospital; Andrea J. Shaer, MD, Medical University of South Carolina, Charleston, SC; Warren Shapiro, MD, Brookdale, NY; Anupkumar Shetty, MD, Henry Ford Health Systems; Jerald Sigala, MD, Orange, CA; David Spiegel, MD, University of Colorado Health Sciences Center; Richard Swartz, MD, University of Michigan; Nosratola Vaziri, MD, University of California Irvine Medical Center; Sergio Vega, MD, West Palm Beach, FL; Kevin Vitting, MD, St Joseph{\textquoteright}s Hospital and Medical Center; Michael Walczyk, MD, Portland, OR; Robert Weiss, DO, Temple University; Duane Wombolt, MD, Norfolk, VA; Elizabeth Wrone, MD, Palo Alto, CA. This paper was supported by a grant from Watson Pharmaceuticals, Inc., to each of the participating centres.",
year = "2004",
month = jun,
doi = "10.1093/ndt/gfh222",
language = "English",
volume = "19",
pages = "1576--1580",
journal = "Nephrology Dialysis Transplantation",
issn = "0931-0509",
number = "6",
}