Treatment of anemia with darbepoetin alfa administered de novo once every other week in chronic kidney disease.
OBJECTIVE
Darbepoetin alfa is an erythropoiesis-stimulating protein that works via the same mechanism and has a threefold longer serum half-life than recombinant human erythropoietin (rHuEPO). The objective of this study was to evaluate extending the dosing interval of darbepoetin alfa to once every other week administration for the treatment of anemia in patients with chronic kidney disease (CKD) not requiring dialysis who were naive to rHuEPO therapy.


METHODS
This was a multi-center, open-label study. Seventy-six rHuEPO-naive patients were enrolled to receive darbepoetin alfa (0.75 microg/kg) once every other week for up to 24 weeks. Doses were titrated to achieve and maintain a hemoglobin target of 11.0 to 13.0 g/dl.


RESULTS
Ninety-seven percent (95% CI: 0.92, 1.00) of patients completing 24 weeks of treatment achieved a hemoglobin response. The median time to response was 5 weeks (range 1-25 weeks). The median darbepoetin alfa dose at the time of response was 60 microg(range 30-130 microg). Darbepoetin alfa was safe and well tolerated, and no antibodies to darbepoetin alfa were detected.


CONCLUSIONS
These results demonstrate the utility of darbepoetin alfa administered once every other week in rHuEPO-naive CKD patients. This new treatment paradigm may allow for more widespread management of anemia in patients with CKD.
Suranyi
Michael G
MG
Liverpool Hospital, Elizabeth Street, Liverpool, Sydney 2170, Australia. Michael.Suranyi@swsahs.nsw.gov.au
Lindberg
Jill S
JS
Navarro
Jesus
J
Elias
Chester
C
Brenner
Robert M
RM
Walker
Rowan
R
D000740:Anemia / Q000188:drug therapy* / Q000209:etiology*; D001315:Australia; D000068256:Darbepoetin alfa; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004921:Erythropoietin / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006454:Hemoglobins / Q000187:drug effects; D006801:Humans; D006973:Hypertension / Q000139:chemically induced; D007676:Kidney Failure, Chronic / Q000150:complications*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014481:United States
D006454:Hemoglobins; D004921:Erythropoietin; D000068256:Darbepoetin alfa