Sodium ferric gluconate therapy in renal transplant and renal failure patients.

Intravenous infusion of sodium ferric gluconate (Ferrlecit) has been reported to be effective and safe in pediatric and adult hemodialysis patients with iron depletion. We sought to expand on the previous studies by treating 13 consecutive pediatric renal failure and renal transplant patients with sodium ferric gluconate doses that were higher than previously reported. Efficacy was defined as: (1) an increase in hematocrit of > or = 3 vol% with no change or a decrease in erythropoietin dose or (2) a stable hematocrit with a decrease of > or = 25% in the erythropoietin, 2 weeks to 2 months after sodium ferric gluconate infusion. Two dosing strategies were employed: (1) high dose, where single dose sodium ferric gluconate (mg) approximately calculated iron deficit, and (2) sodium ferric gluconate, 62.5 mg/dose for children < 40 kg, 125 mg/dose for children > 40 kg, infused on eight consecutive hemodialysis runs. There was only one self-limited adverse reaction in 60 doses. Three patients with previous adverse reactions to iron dextran tolerated sodium ferric gluconate without adverse effect. Sodium ferric gluconate was efficacious in eight out of ten patients that received a cumulative dose > 5 mg/kg. The mean hematocrit increased 30.3 +/- 7.8 to 36.4 +/- 4.4 vol% (P = 0.04) and the mean erythropoietin dose decreased 251.5 +/- 149.1 to 100.7 +/- 113.0 units/kg/week (P = 0.02). Although sodium ferric gluconate appears to be effective and safe at the doses used, multicenter, prospective pharmacokinetic and clinical trials of sodium ferric gluconate should be conducted in children.