A randomized, controlled parallel-group trial on efficacy and safety of iron sucrose (Venofer (R)) vs iron gluconate (Ferrlecit (R)) in haemodialysispatients treated with rHuEpo

Background, The objectives of the present trial were to compare the efficac y and safety of two i.v. iron preparations with respect to haemoglobin leve ls, iron status and recombinant human erythropoetin (rHuEpo) dosage require ments in stable, rHuEpo-treated haemodialysis patients (maintenance phase o f iron treatment) over 6 months. Methods. A total of 59 patients were randomized and assigned to one of two treatment groups and 55 patients were analysed (iron sucrose n=27, iron glu conate n=28). Iron sucrose was administered in a dose of 250 mg iron dilute d in 100 mi normal saline given over 60 min once per month, while 62.5 mg i ron as iron gluconate was given once per week in a slow push injection (5 m in), Results. Efficacy parameters: Haemoglobin levels could be maintained from b aseline to endpoint in both groups. There were, however. more patients in t he iron sucrose group than in the iron gluconate group for whom treatment w as discontinued because their haemoglobin values exceeded 12.5 g/dl or ferr itin values exceeded 1000 ng/ml (five vs two and three vs one patient, resp ectively). Transferrin saturation and serum ferritin increased significantl y in both groups (+255.7 ng/ml with iron sucrose and +278.5 ng/ml with iron gluconate), while rHuEpo dosage did not change significantly throughout th e study. Safety parameters: There were a total of 174 infusions of iron suc rose and 720 injections of iron gluconate during the trial; all of them wer e well tolerated. In particular, we did not observe anaphylactoid reactions or any events suggestive of iron toxicity such as hypotension, dizziness, or nausea. Conclusions. High doses of iron sucrose (Venofer(R) at a dose of 250 mg,mon th) was equally effective in maintaining haemoglobin and equally well toler ated as low doses of iron gluconate (Ferrlecit(R) at a dose of 62.5 mg once per week) in stable, rHuEpo treated haemodialysis patients.