Darbepoetin alfa effectively treats anemia in patients with chronic kidney disease with de novo every-other-week administration.
OBJECTIVE
This multicenter, open-label study determined safety and efficacy of once-every-other-week administration of darbepoetin alfa for anemia of chronic kidney disease in erythropoietin-naive patients not on dialysis.


METHODS
Participants with hemoglobin levels <11.0 g/dl at baseline were administered darbepoetin alfa at an initial dosage of 0.75 microg/kg once every other week. The dose was titrated to achieve and maintain a hemoglobin response, defined as a hemoglobin range of between 11.0 and 13.0 g/dl for up to 24 weeks. The primary end point was the dose of darbepoetin alfa at initial hemoglobin response.


RESULTS
Six hundred and eight patients were enrolled, and 463 completed the study; 95% (95% confidence interval: 0.93, 0.97) of the patients who completed treatment achieved a hemoglobin response. The mean darbepoetin alfa dose at the time of response was 63.5 +/- (SD) 16.9 microg, and the mean time to hemoglobin response was 5.7 +/- (SD) 4.5 weeks. Oral iron therapy was administered to 60% and intravenous iron to 16% of the participants. Darbepoetin alfa was well tolerated, and adverse events were consistent with those expected in patients with chronic kidney disease.


CONCLUSIONS
Darbepoetin alfa administered once every other week is effective and safe for achieving and maintaining target hemoglobin levels in anemic patients with chronic kidney disease.
University of Texas Southwestern Medical Center, Dallas, TX 75390-8856, USA. robert.toto@utsouthwestern.edu
Robert D
RD
Toto
Vincent
V
Pichette
Jesus
J
Navarro
Robert
R
Brenner
Wendi
W
Carroll
Wei
W
Liu
Simon
S
Roger
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000188:drug therapy* / Q000209:etiology; D000068256:Darbepoetin alfa; D004359:Drug Therapy, Combination; D004921:Erythropoietin / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D006454:Hemoglobins; D006801:Humans; D007501:Iron / Q000008:administration & dosage; D007676:Kidney Failure, Chronic / Q000150:complications*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
D006454:Hemoglobins; D004921:Erythropoietin; D000068256:Darbepoetin alfa; D007501:Iron