37380
document
Safety of ferumoxytol in patients with anemia and CKD . 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 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 anemic patients with CKD stages 1 to 5 and 5D .
37381
Intervention_Pharmacological
ferumoxytol
37382
Intervention_Pharmacological
iron replacement therapies
37383
Intervention_Pharmacological
Ferumoxytol
37384
Intervention_Pharmacological
ferumoxytol
37385
Intervention_Control
placebo-controlled
37386
Intervention_Pharmacological
ferumoxytol
37387
Intervention_Control
saline
37388
Intervention_Pharmacological
as placebo
37389
Intervention_Pharmacological
ferumoxytol
37390
Intervention_Control
saline
37391
Intervention_Pharmacological
placebo
37392
Intervention_Physical
dialysis therapy
37393
Intervention_Pharmacological
ferumoxytol
37394
Intervention_Control
placebo
37395
Intervention_Control
placebo
37396
Intervention_Pharmacological
ferumoxytol
37397
Intervention_Control
placebo
37398
Intervention_Pharmacological
ferumoxytol
37399
Intervention_Control
placebo
37400
Intervention_Pharmacological
ferumoxytol
37401
Intervention_Control
placebo
37402
Intervention_Pharmacological
Ferumoxytol
37403
Intervention_Control
placebo
37404
Outcome_Other
Safety
37405
Outcome_Other
safety
37406
Outcome_Adverse-effects
adverse events
37407
Outcome_Physical
laboratory tests
37408
Outcome_Physical
vital signs
37409
Outcome_Adverse-effects
adverse events
37410
Outcome_Adverse-effects
incidence of related adverse events
37411
Outcome_Adverse-effects
adverse events
37412
Outcome_Adverse-effects
symptoms
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Outcome_Adverse-effects
injection/infusion site , dizziness , pruritus , headache , fatigue , and nausea . Serious adverse events
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Outcome_Adverse-effects
Serious related adverse events
37415
Outcome_Physical
blood pressure
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Outcome_Other
tolerated
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Outcome_Other
safety profile
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Participant_Condition
anemia and CKD
37419
Participant_Condition
chronic kidney disease ( CKD )
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Participant_Condition
CKD stages 1 to 5 and 5D
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Participant_Sample-size
750
37422
Participant_Condition
CKD stages 1 to 5 and 5D
37423
Participant_Sample-size
750
37424
Participant_Condition
CKD
37425
Participant_Sample-size
713
37426
Participant_Sample-size
711
37427
Participant_Sample-size
420
37428
Participant_Sample-size
242
37429
Participant_Sample-size
152
37430
Participant_Sample-size
178
37431
Participant_Sample-size
119
37432
Participant_Condition
anemic
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Participant_Condition
CKD stages 1 to 5 and 5D