The safety and efficacy of ferumoxytol therapy in anemic chronic kidney disease patients.
BACKGROUND
Administration of safe and effective iron therapy in patients with chronic kidney disease is a time consuming process. This phase II clinical trial studied ferumoxytol, a semi-synthetic carbohydrate-coated iron oxide administered by rapid intravenous injection to anemic chronic kidney disease patients (predialysis or undergoing peritoneal dialysis).


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.


CONCLUSIONS
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.
Spinowitz
Bruce S
BS
Division of Nephrology and Hypertension, The New York Hospital Medical Center of Queens, Flushing, New York 11355, USA.
Schwenk
Michael H
MH
Jacobs
Paula M
PM
Bolton
W Kline
WK
Kaplan
Mark R
MR
Charytan
Chaim
C
Galler
Marilyn
M
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D002908:Chronic Disease; D005260:Female; D005293:Ferritins / Q000097:blood; D052203:Ferrosoferric Oxide / Q000008:administration & dosage* / Q000009:adverse effects; D006400:Hematocrit; D006454:Hemoglobins; D006801:Humans; D007275:Injections, Intravenous; D007676:Kidney Failure, Chronic / Q000150:complications* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D010530:Peritoneal Dialysis; D017701:Reticulocyte Count; D014168:Transferrin / Q000378:metabolism; D016896:Treatment Outcome
D006454:Hemoglobins; D014168:Transferrin; D005293:Ferritins; D052203:Ferrosoferric Oxide