Randomized study of darbepoetin alfa and recombinant human erythropoietin for treatment of renal anemia in chronic renal failure patients receiving peritoneal dialysis.
OBJECTIVE
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.


METHODS
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.


RESULTS
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).


CONCLUSIONS
Both darbepoetin alfa and r-HuEPO safely maintain hemoglobin levels within the target range in peritoneal dialysis patients.
Li
Wen-Yi
WY
Department of Internal Medicine, National Taiwan University Hospital Yun-Lin Branch, Yun-Lin, Taiwan.
Chu
Tzong-Shinn
TS
Huang
Jenq-Wen
JW
Wu
Ming-Shiou
MS
Wu
Kwan-Dun
KD
D000328:Adult; D000740:Anemia / Q000188:drug therapy* / Q000209:etiology; D000068256:Darbepoetin alfa; D004334:Drug Administration Schedule; D004921:Erythropoietin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006397:Hematinics / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007676:Kidney Failure, Chronic / Q000150:complications* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010530:Peritoneal Dialysis; D016896:Treatment Outcome
D006397:Hematinics; D004921:Erythropoietin; D000068256:Darbepoetin alfa