Randomized Study of Darbepoetin Alfa and Recombinant Human Erythropoietin for Treatment of Renal Anemia in Chronic Renal Failure Patients Receiving Peritoneal Dialysis

Abstract

Darbepoetin alfa can be administered less frequently than recombinant human erythropoietin (r-HuEPO) for the treatment of anemia in chronic renal failure (CRF) patients. We aimed to confirm that darbepoetin alfa at a reduced dosing schedule can safely maintain a target hemoglobin level in CRF patients undergoing peritoneal dialysis. Forty-five PD patients receiving r-HuEPO were randomized in a 1:1 ratio to continue r-HuEPO or to change to darbepoetin alfa (open-label). Patients were maintained within a target range of haemoglobin for 5.5 months by adjusting the dose and then the frequency of darbepoetin alfa and r-HuEPO over the initial 4 months. The evaluation period was the final 1.5 months. A total of 37 patients completed the study. During the evaluation period, the hemoglobin of the darbepoetin alfa group was higher than that in the baseline period (10.46 +/- 0.22 g/dL vs. 9.98 +/- 0.18 g/dL, p < 0.05). Hemoglobin remained similar in the r-HuEPO group. The average dose in the darbepoetin alfa group was 93.0 microg/month, while the average dose in the r-HuEPO group was 18,339.9 units/month. The dosing frequency was less in the darbepoetin alfa group (3.9 times/month vs. 9.2 times/month). We divided the darbepoetin alfa group into low-dose (< 70 microg/month) and high-dose (> or = 70 microg/month) subgroups. The body weight in the high-dose group was higher than that in the low-dose group (66 +/- 11 kg vs. 52 +/- 4.4 kg, p < 0.01). Both darbepoetin alfa and r-HuEPO safely maintain hemoglobin levels within the target range in peritoneal dialysis patients.