The safety and efficacy of ferumoxytol therapy in anemic chronic kidney disease patients

Spinowitz, Bruce; Schwenk, Michael H.; Jacobs, Paula; Bolton, W. Kline; Kaplan, Mark; Charytan, Chaim; Galler, Marilyn

doi:10.1111/j.1523-1755.2005.00598.x

Cited by 67 publications

(50 citation statements)

References 19 publications

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“…Rapid intravenous injection (30 mg/s iron) offers such a therapy for patients who have CKD and are not on dialysis or patients who undergo peritoneal dialysis. Adverse drug events included constipation, chills, tingling, delayed pruritic erythematous rash, and transient pain at the injection site in some patients (134). Ferumoxytol injected at 60 mg/min was well tolerated in the majority of the patients.…”

Section: Evaluation Of Various Iron Preparationsmentioning

confidence: 99%

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Clinical Aspects of Iron Use in the Anemia of Kidney Disease

Hörl¹

2007

Journal of the American Society of Nephrology

127

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Section: Evaluation Of Various Iron Preparationsmentioning

confidence: 99%

“…The safety and the efficacy of ferumoxytol, a semisynthetic carbohydrate-coated iron oxide, was studied recently in a phase II clinical trial (134). Rapid intravenous injection (30 mg/s iron) offers such a therapy for patients who have CKD and are not on dialysis or patients who undergo peritoneal dialysis.…”

Section: Evaluation Of Various Iron Preparationsmentioning

confidence: 99%

Clinical Aspects of Iron Use in the Anemia of Kidney Disease

Hörl¹

2007

Journal of the American Society of Nephrology

127

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“…However, to date these agents have not been evaluated in humans, whereas ferumoxtran-10 has almost completed phase 3 clinical testing. Ferumoxytol is currently undergoing phase 2 clinical testing for different indications (19,20). Most recently, ferumoxytol has been successfully evaluated as blood-pool contrast agent for first-pass MRA in healthy volunteers and patients for various vascular territories allowing for a selective display of arteries and veins in a single exam (21).…”

Section: Discussionmentioning

confidence: 99%

Magnetic resonance imaging of experimental atherosclerotic plaque: Comparison of two ultrasmall superparamagnetic particles of iron oxide

Herborn

Vogt

Lauenstein

et al. 2006

Magnetic Resonance Imaging

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Purpose: To evaluate a new ultrasmall superparamagnetic particles of iron oxide (USPIO) compound, ferumoxytol, as a marker of macrophage activity in atherosclerotic plaques and to compare it to ferumoxtran-10. Materials and Methods:Ten mature heritable hyperlipidemic (WHHL) female Watanabe rabbits served as the animal model for atherosclerosis, four coeval female New Zealand White (NZW) rabbits were the control group. Five WHHL and two NZW received a single intravenous injection (250 mol/kg) of either ferumoxtran-10 or ferumoxytol and were subjected to daily MR examinations on a 1.5T whole body scanner for the next five days. Development of signal intensity changes and susceptibility effects was assessed. Statistical analysis was based on a nonparametric WilcoxonMann-Whitney-U test by using a P value at the 0.05 significance level. On day 5, the rabbits were sacrificed and the aorta was referred to histopathology, distribution of iron particles in the vessel wall was analyzed.Results: MRI was feasible in all animals. Three days after injection of ferumoxytol the highest luminal signal intensity measurements were observed in the ferumoxytol group; the highest measurements were five days after injection in the ferumoxtran-10 group (P Ͻ 0.05). In the WHHL, susceptibility effects presented as homogeneous dark lines parallel to the aortic wall after ferumoxytol and spotted areas void of signal after ferumoxtran-10. None of these findings were observed in the NZW control groups. Conclusion:Ferumoxtran-10 and ferumoxytol at a respective dose of 250 mol/kg appear well suited for atherosclerotic plaque detection with MRI in experimental atherosclerosis. Ferumoxytol warrants further analysis in humans.

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“…For future studies, sequences will be investigated that are better adapted for use in the equilibrium phase and that might reduce signal loss artifacts. Although ferumoxytol was recently approved for use in chronic kidney disease patients up to a dose of 510 mg (13,14), the administered dose for first-pass MR angiography needs careful consideration. Its high r2 relaxivity (83 mmol/sec at 0.47 T) compared with gadolinium-based agents (gadopentetate dimeglumine: 4 mmol/sec at 0.47 T), reflection of its greater insensitivity to flow artifacts.…”

Section: Technical Developments: Enhanced Mr Angiography Of Avf In Rementioning

confidence: 99%

USPIO-enhanced MR Angiography of Arteriovenous Fistulas in Patients with Renal Failure

Sigovan¹,

Gasper²,

Alley³

et al. 2012

Radiology

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Purpose:To determine the feasibility of using ferumoxytol-enhanced magnetic resonance (MR) angiography to depict the vasculature of hemodialysis fistulas and improve image quality compared with nonenhanced time-of-flight (TOF) MR angiography. Materials and Methods:The study was institutional review board approved and was in compliance with HIPAA regulations. All participants provided written informed consent. TOF and firstpass ferumoxytol-enhanced MR angiography were performed in 10 patients with upper extremity autogenous fistulas. Ferumoxytol was administered as a bolus solution containing 430 µmol of elemental iron. A qualitative comparison was performed on maximum intensity projection images. Lumen depiction was evaluated by using a fivepoint scale. The uniformity of intraluminal signal intensity was measured as the ratio between the mean signal intensity of the entirety of the imaged fistula and its standard deviation. The contrast-to-noise ratio (CNR) between intraluminal signal and adjacent tissue was evaluated as a function of image acquisition time. Lumen depiction scores, luminal signal heterogeneity, and CNR efficiency were compared between TOF and ferumoxytol-enhanced MR angiography by using a Wilcoxon-Mann-Whitney test. Results:Flow artifacts were greatly reduced by the use of ferumoxytol-enhanced MR angiography. Ferumoxytol-enhanced MR angiography had significantly better performance than TOF MR angiography as measured with the following: lumen depiction scores in all segments (mean, 4.7 6 0.1 [standard error of the mean]; vs 3.0 6 0.3 for arterial inflow, 4.1 6 0.3 vs 1.9 6 0.3 for arterial outflow, 3.7 6 0.3 vs 1.8 6 0.2 for anastomosis, and 4.5 6 0.2 vs 2.1 6 0.2 for venous outflow; P , .001), intraluminal signal homogeneity (0.3 6 0.02 vs 0.4 6 0.06, P = .005), and CNR efficiency in the venous outflow (5.1 6 0.6 vs 2.5 6 0.4, P = .01). Conclusion:This study demonstrates the feasibility of using ferumoxytol-enhanced MR angiography in imaging hemodialysis fistulas with consistently superior image quality compared with nonenhanced TOF MR angiography.q RSNA, 2012

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The safety and efficacy of ferumoxytol therapy in anemic chronic kidney disease patients

Abstract: Although larger studies are required, this small study demonstrates that ferumoxytol can be safe and effective in increasing iron stores, is associated with an increased hemoglobin response, and is well tolerated at a rapid infusion rate.

Cited by 67 publications

References 19 publications

Clinical Aspects of Iron Use in the Anemia of Kidney Disease

Clinical Aspects of Iron Use in the Anemia of Kidney Disease

Magnetic resonance imaging of experimental atherosclerotic plaque: Comparison of two ultrasmall superparamagnetic particles of iron oxide

USPIO-enhanced MR Angiography of Arteriovenous Fistulas in Patients with Renal Failure

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