Intravenous iron therapy is recommended for children and adults who receive hemodialysis (HD) and recombinant human erythropoietin (rHuEPO). However, limited information exists on the use of any maintenance IV iron regimen in children. Therefore, we conducted a prospective, multicenter, open-label trial of maintenance therapy with sodium ferric gluconate complex (SFGC) in iron-replete pediatric HD patients receiving rHuEPO. Patients received SFGC weekly at an initial dose of 1.0 mg kg(-1) week(-1), not to exceed 125 mg. Doses could be adjusted based on iron indices. Twenty-three patients (mean age: 13.2+/-2.39 years) were enrolled and received at least one dose of SFGC, while twelve patients completed the study. After 12 weeks of treatment, the mean SFGC dose delivered was 1.0 mg/kg. Mean TSAT and serum ferritin levels remained within NKF-K/DOQI target ranges and the mean Hgb level remained unchanged from baseline. No unexpected or unusual safety risks were associated with SFGC use. In summary, this experience provides evidence for the safety and efficacy of intravenous SFGC and supports the recommendation that the maintenance SFGC starting dose should be 1.0 mg/kg, not to exceed 125 mg, with subsequent adjustments made according to TSAT and/or serum ferritin levels.