A comparison of haemoglobin levels and doses in haemodialysis patients treated with subcutaneous or intravenous darbepoetin alfa: a German prospective, randomized, multicentre study

Background. The different efficacy of subcutaneous and intravenous rHuEPO results in higher doses and costs in intravenously treated patients. Darbepoetin alfa has a different pharmacokinetic profile compared to rHuEPO, and previous clinical experience suggests that subcutaneous and intravenous darbepoetin alfa may have similar efficacy. Objective. The aim of this study was to compare the efficacy of intravenous and subcutaneous darbepoetin alfa regarding haemoglobin levels and doses. Methods. Patients treated with subcutaneous darbepoetin alfa for at least 6 months were randomized 1:1 to continue with subcutaneous treatment of darbepoetin alfa or to switch to the intravenous administration route. The application frequency was not altered. Darbepoetin alfa dose as well as haemoglobin concentrations were evaluated as per patient average at baseline (Week -3 +/- 1), Week 24 +/- 3 and Week 48 +/- 3. Results. One hundred fourteen patients in 9 German dialysis centres were included. Fifty-three patients were treated intravenously and 61 patients continued the subcutaneous therapy. Mean haemoglobin levels and mean weekly darbepoetin alfa dose did not change significantly in either treatment group. Conclusions. Our data suggest that the darbepoetin alfa dose can be kept constant if patients are switched from subcutaneous to intravenous treatment.