Abstract | BACKGROUND: METHODS: Inclusion criteria included hemoglobin < or =12.5 g/dL and transferrin saturation < or =35%. Twenty-one adult patients were randomized to receive ferumoxytol in a regimen of 4 doses of 255 mg iron in 2 weeks or 2 doses of 510 mg iron in 1 to 2 weeks. Ferumoxytol was administered at a rate of up to 30 mg iron/sec. RESULTS: The maximum hemoglobin response following ferumoxytol administration occurred at 6 weeks, increasing from a baseline of 10.4 +/- 1.3 g/dL to 11.4 +/- 1.2 g/dL (P < 0.05). Ferritin increased from a baseline of 232 +/- 216 ng/mL to a maximum of 931 +/- 361 ng/mL at 2 weeks (P < 0.05), while the baseline transferrin saturation increased from 21 +/- 10% to 37 +/- 22% at 1 week (P < 0.05). Seven adverse events in 5 patients during this trial were deemed possibly related to ferumoxytol, none serious. These events included constipation, chills, tingling, a gastrointestinal viral syndrome, delayed pruritic erythematous rash, and transient pain at the injection site. CONCLUSION: 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.
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Authors | Bruce S Spinowitz, Michael H Schwenk, Paula M Jacobs, W Kline Bolton, Mark R Kaplan, Chaim Charytan, Marilyn Galler |
Journal | Kidney international
(Kidney Int)
Vol. 68
Issue 4
Pg. 1801-7
(Oct 2005)
ISSN: 0085-2538 [Print] United States |
PMID | 16164657
(Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Hemoglobins
- Transferrin
- Ferritins
- Ferrosoferric Oxide
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Anemia
(blood, drug therapy, etiology)
- Chronic Disease
- Female
- Ferritins
(blood)
- Ferrosoferric Oxide
(administration & dosage, adverse effects)
- Hematocrit
- Hemoglobins
- Humans
- Injections, Intravenous
- Kidney Failure, Chronic
(complications, therapy)
- Male
- Middle Aged
- Peritoneal Dialysis
- Reticulocyte Count
- Transferrin
(metabolism)
- Treatment Outcome
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