Sodium ferric gluconate complex in sucrose is safe and effective in hemodialysis patients: North American clinical trial

A new intravenous (IV) iron compound, sodium ferric gluconate complex in su crose (Ferrlecit, R&D Laboratories, Inc, Marina Del Rey, CA), was administe red over 8 consecutive dialysis days in equally divided doses to a total of either 0.5 or 1.0 g in a controlled, open, multicenter, randomized clinica l study of anemic, iron-deficient hemodialysis patients receiving recombina nt human erythropoietin (rHuEPO), Effectiveness was assessed by increase in hemoglobin and hematocrit and changes of iron parameters. Results were com pared with historically matched controls on oral iron. High-dose IV treatme nt with 1.0 g sodium ferric gluconate complex in sucrose resulted in signif icantly greater improvement in hemoglobin, hematocrit, iron saturation, and serum ferritin at all time points, as compared with low-dose IV (0.5 g) or oral iron treatment. Despite an initial improvement in mean serum ferritin and transferrin saturation, 500 mg IV therapy did not result in a signific ant improvement in hemoglobin at any time. Eighty-three of 88 patients comp leted treatment with sodium ferric gluconate complex in sucrose: 44 in the high-dose and 39 in the low-dose group. Two patients discontinued for perso nal reasons. The other three discontinued because of a rash, nausea and ras h, and chest pain with pruritus, respectively. In comparison with 25 matche d control patients, adverse events could not be linked to drug therapy, nor was there a dose effect. In conclusion, sodium ferric gluconate complex in sucrose is safe and effective in the management of iron-deficiency anemia in severely iron-deficient and anemic hemodialysis patients receiving rHuEP O, This study confirms the concepts regarding iron therapy expressed in the National Kidney Foundation Dialysis Outcomes Quality Initiative (NKF-DOQI) that hemodialysis patients with serum ferritin below 100 ng/mL or transfer rin saturations below 18% need supplementation with parenteral iron in exce ss of 1.0 g to achieve optimal response in hemoglobin and hematocrit levels . (C) 1999 by the National Kidney Foundation, Inc.