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Am J Kidney Dis. 2013 Apr;61(4):588-97. doi: 10.1053/j.ajkd.2012.10.019. Epub 2012 Dec 12.

Comparison of the safety and efficacy of 3 iron sucrose iron maintenance regimens in children, adolescents, and young adults with CKD: a randomized controlled trial.

Author information

1
University of Cincinnati College of Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA. stuart.goldstein@cchmc.org

Abstract

BACKGROUND:

Iron deficiency is a common cause of anemia in young persons with chronic kidney disease (CKD). Iron repletion with intravenous (IV) iron formulations has been studied in children; maintenance IV iron regimens have not been reported extensively.

STUDY DESIGN:

A multicenter randomized trial of IV iron sucrose.

SETTING & PARTICIPANTS:

145 children, adolescents, and young adults with CKD receiving erythropoiesis-stimulating agent (ESA) therapy were stratified by dialysis category (hemodialysis, peritoneal dialysis, or non-dialysis dependent) and weight (<50 and ≥50 kg).

INTERVENTION:

Patients were randomly assigned to 1 of 3 dosing arms: 0.5, 1.0, or 2.0 mg/kg (maximum single dose, 100 mg), stratified into hemodialysis versus nonhemodialysis (peritoneal dialysis or non-dialysis-dependent CKD) groups. Patients treated with hemodialysis received study medication once every other week for 6 doses. Patients in the nonhemodialysis group received study medication once every 4 weeks for 3 doses.

OUTCOMES:

We assessed adverse event rates between dosing groups. The main clinical end point was a composite of hemoglobin level ≥10.5-14.0 g/dL, inclusive; transferrin saturation ≥20%-50%, inclusive; and stable ESA dosing (±25% of baseline dose).

RESULTS:

Between-group difference for composite clinical end point rate attainment was -3.9% (95% CI, -21.4% to 13.7%) for the 1.0-mg/kg group versus 0.5-mg/kg group, +3.9% (95% CI, -15.1% to 23.0%) for the 2-mg/kg group versus 0.5-mg/kg group, and +7.8% (95% CI, -10.9% to 26.5%) for the 2-mg/kg group versus 1-mg/kg group. No differences were noted between regimens in reported adverse effects, which were all minor.

LIMITATIONS:

Absence of a control group receiving no IV iron. Short duration of intervention and observation. A small proportion of patients having achieved the primary clinical outcome.

CONCLUSIONS:

IV iron sucrose at a dose of 0.5 mg/kg at the intervals prescribed is noninferior to higher doses in maintaining hemoglobin levels >10.5 g/dL in children, adolescents, and young adults receiving ESA therapy.

PMID:
23245582
DOI:
10.1053/j.ajkd.2012.10.019
[Indexed for MEDLINE]
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