Elsevier

Kidney International

Volume 66, Issue 3, September 2004, Pages 1193-1198
Kidney International

Clinical Nephrology – Epidemiology – Clinical Trials
Iron sucrose in hemodialysis patients: Safety of replacement and maintenance regimens

https://doi.org/10.1111/j.1523-1755.2004.00872.xGet rights and content
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Iron sucrose in hemodialysis patients: Safety of replacement and maintenance regimens.

Background

Parenteral iron replacement and maintenance are frequently required in hemodialysis patients. However, serious adverse events have been reported after single doses of some intravenous iron products. This multicenter phase IV clinical trial examined the safety of iron sucrose for the treatment of iron deficiency and for the maintenance of iron sufficiency in hemodialysis patients.

Methods

In this safety study, iron sucrose was given in two dosing regimens. Iron deficient patients were treated with intravenous iron sucrose, 100 mg, during 10 consecutive hemodialysis sessions (replacement regimen). Iron replete patients were given iron sucrose, 100 mg intravenous (iv) over 5 minutes, weekly for 10 weeks (maintenance regimen). At the end of each 10-dose cycle, iron status was reassessed, and dosing during the subsequent cycle was based on the adequacy of iron stores as per Dialysis Outcome Quality Initiative (K/DOQI) Guidelines. With each dosing regimen, adverse events, if any, were recorded and described.

Results

Six hundred and sixty-five hemodialysis patients, including 80 who had experienced previous intolerance to other parenteral iron preparations, received a total of 8583 doses of iron sucrose. One hundred eighty-eight patients received more than one iv iron cycle (replacement, maintenance, or both). There were no serious or life-threatening drug-related adverse events.

Conclusion

Iron sucrose is safe when given as treatment for iron deficiency or for maintenance of iron stores.

KEYWORDS

iron sucrose
hemodialysis
anemia
iron deficiency
safety

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