A trial of subcutaneous administration of darbepoetin alfa once every other week for the treatment of anemia in peritoneal dialysis patients.

BACKGROUND

Darbepoetin alfa (Aranesp, Amgen) is an erythropoietic stimulating protein with a three fold longer terminal half life than recombinant human erythropoietin (rHuEPO). The purpose of this single center, single arm study was to determine whether darbepoetin alfa is as effective as rHuEPO for the treatment of renal anemia in patients on peritoneal dialysis when administered at a reduced dosing frequency of once every other week irrespective of the initial rHuEPO dose frequency.

METHODS

A total of 17 patients on peritoneal dialysis receiving stable rHuEPO therapy were changed to darbepoetin alfa every other week, using the recommended 200:1 conversion factor . The doses of darbepoetin alfa were titrated to maintain hemoglobin within -1.0 to +1.5 g/dL of the patients' baseline value and also within a range of 10.0 to 13.0 g/dL for up to 24 weeks (20 weeks dose titration period followed by 4 week evaluation period). The primary end point was change in hemoglobin levels between baseline and evaluation period.

RESULTS

Mean change in hemoglobin levels from baseline to evaluation period was 0.03 g/dL (95% CI -0.62 to +0.69). This was not a statistically significant or clinically relevant difference, despite the reduced frequency of darbepoetin alfa administration. There were no serious or major adverse effects observed with darbepoetin alfa during the study.

CONCLUSION

These results show that darbepoetin alfa maintains hemoglobin concentrations effectively and safely in patients on peritoneal dialysis, but with a reduced dose frequency as compared to rHuEPO.