BACKGROUND: Iron deficiency anemia is a common complication in patients with chronic kidney disease (CKD). Currently available intravenous (IV) iron replacement therapies have either inconvenient regimens of administration or adverse event profiles that limit their utility in the outpatient setting. Ferumoxytol is a novel, semisynthetic, carbohydrate-coated, superparamagnetic iron oxide nanoparticle that is administered IV as an injection. The main objective of this study was to assess the safety of ferumoxytol for the treatment of patients with CKD stages 1 to 5 and 5D. STUDY DESIGN: Phase 3, randomized, double-blind, placebo-controlled, crossover, multicenter study of a single 510-mg dose of ferumoxytol versus saline as placebo. SETTING & PARTICIPANTS: 750 patients with CKD stages 1 to 5 and 5D. INTERVENTION: An IV injection of either 17 mL of ferumoxytol or saline placebo over 17 seconds on day 0 and the alternate agent on day 7. OUTCOMES & MEASUREMENTS: Descriptive comparison of adverse events, laboratory tests, and vital signs. RESULTS: Of 750 randomly assigned patients with CKD, 60% were not on dialysis therapy. 713 patients receivedferumoxytol, and 711 received placebo. There were 420 adverse events reported; 242 in 152 patients (21.3%) with ferumoxytol and 178 in 119 patients (16.7%) with placebo. The incidence of related adverse events was 5.2% with ferumoxytol and 4.5% with placebo. The most common related adverse events after each treatment included symptoms related to the injection/infusion site, dizziness, pruritus, headache, fatigue, and nausea. Serious adverse events occurred in 21 patients (2.9%) after ferumoxytol and 13 patients (1.8%) after placebo. Serious related adverse events were observed in 1 patient (0.1%) after each treatment. There was no meaningful decrease in blood pressure after administration of ferumoxytol or placebo. LIMITATIONS: Follow-up was 7 days after each study treatment. CONCLUSIONS:Ferumoxytol is well tolerated and has a safety profile similar to placebo in anemic patients with CKD stages 1 to 5 and 5D.
RCT Entities:
BACKGROUND:Irondeficiency anemia is a common complication in patients with chronic kidney disease (CKD). Currently available intravenous (IV) iron replacement therapies have either inconvenient regimens of administration or adverse event profiles that limit their utility in the outpatient setting. Ferumoxytol is a novel, semisynthetic, carbohydrate-coated, superparamagnetic iron oxide nanoparticle that is administered IV as an injection. The main objective of this study was to assess the safety of ferumoxytol for the treatment of patients with CKD stages 1 to 5 and 5D. STUDY DESIGN: Phase 3, randomized, double-blind, placebo-controlled, crossover, multicenter study of a single 510-mg dose of ferumoxytol versus saline as placebo. SETTING & PARTICIPANTS: 750 patients with CKD stages 1 to 5 and 5D. INTERVENTION: An IV injection of either 17 mL of ferumoxytol or saline placebo over 17 seconds on day 0 and the alternate agent on day 7. OUTCOMES & MEASUREMENTS: Descriptive comparison of adverse events, laboratory tests, and vital signs. RESULTS: Of 750 randomly assigned patients with CKD, 60% were not on dialysis therapy. 713 patients received ferumoxytol, and 711 received placebo. There were 420 adverse events reported; 242 in 152 patients (21.3%) with ferumoxytol and 178 in 119 patients (16.7%) with placebo. The incidence of related adverse events was 5.2% with ferumoxytol and 4.5% with placebo. The most common related adverse events after each treatment included symptoms related to the injection/infusion site, dizziness, pruritus, headache, fatigue, and nausea. Serious adverse events occurred in 21 patients (2.9%) after ferumoxytol and 13 patients (1.8%) after placebo. Serious related adverse events were observed in 1 patient (0.1%) after each treatment. There was no meaningful decrease in blood pressure after administration of ferumoxytol or placebo. LIMITATIONS: Follow-up was 7 days after each study treatment. CONCLUSIONS:Ferumoxytol is well tolerated and has a safety profile similar to placebo in anemicpatients with CKD stages 1 to 5 and 5D.
Authors: Medha Airy; Sreedhar Mandayam; Aya A Mitani; Tara I Chang; Victoria Y Ding; M Alan Brookhart; Benjamin A Goldstein; Wolfgang C Winkelmayer Journal: Nephrol Dial Transplant Date: 2015-08-26 Impact factor: 5.992
Authors: M M Stollenwerk; I Pashkunova-Martic; C Kremser; H Talasz; G C Thurner; A A Abdelmoez; E A Wallnöfer; A Helbok; E Neuhauser; N Klammsteiner; L Klimaschewski; E von Guggenberg; E Fröhlich; B Keppler; W Jaschke; P Debbage Journal: Histochem Cell Biol Date: 2010-02-20 Impact factor: 4.304
Authors: Robert Provenzano; Brigitte Schiller; Madhumathi Rao; Daniel Coyne; Louis Brenner; Brian J G Pereira Journal: Clin J Am Soc Nephrol Date: 2009-01-28 Impact factor: 8.237
Authors: Gerda B Toth; Csanad G Varallyay; Andrea Horvath; Mustafa R Bashir; Peter L Choyke; Heike E Daldrup-Link; Edit Dosa; John Paul Finn; Seymur Gahramanov; Mukesh Harisinghani; Iain Macdougall; Alexander Neuwelt; Shreyas S Vasanawala; Prakash Ambady; Ramon Barajas; Justin S Cetas; Jeremy Ciporen; Thomas J DeLoughery; Nancy D Doolittle; Rongwei Fu; John Grinstead; Alexander R Guimaraes; Bronwyn E Hamilton; Xin Li; Heather L McConnell; Leslie L Muldoon; Gary Nesbit; Joao P Netto; David Petterson; William D Rooney; Daniel Schwartz; Laszlo Szidonya; Edward A Neuwelt Journal: Kidney Int Date: 2017-04-20 Impact factor: 10.612
Authors: Anne M Muehe; Dan Feng; Rie von Eyben; Sandra Luna-Fineman; Michael P Link; Travis Muthig; Amy E Huddleston; Edward A Neuwelt; Heike E Daldrup-Link Journal: Invest Radiol Date: 2016-04 Impact factor: 6.016