Randomized trial to compare the dosage of darbepoetin alfa by administration route in haemodialysis patients.
OBJECTIVE
The doses of darbepoetin alfa required to maintain target haemoglobin levels after s.c. or i.v. administration when recombinant human erythropoietin (rHuEpo) treatment was replaced by darbepoetin alfa treatment in haemodialysis (HD) patients were compared.


METHODS
In this prospective, randomized, open-label study, 65 HD patients who were receiving stable SC doses of rHuEpo were switched to an equivalent dose of darbepoetin alfa at a reduced frequency by s.c. or i.v. administration. Patients were randomly assigned to the s.c. group (n = 32) or the i.v. group (n = 33). Darbepoetin alfa doses were titrated to maintain target haemoglobin levels of 8.0-11.0 g/dL for up to 24 weeks. A period of 20 weeks was used for dose titration and haemoglobin stabilization. This was followed by a 4 week evaluation period.


RESULTS
The mean haemoglobin concentration during the evaluation period was similar in the s.c. and i.v. groups. The mean dose and mean weight-standardized dose of darbepoetin alfa during the evaluation period tended to be lower in the s.c. group than the i.v. group, although these differences were not statistically significant. The mean weekly darbepoetin alfa dose requirements during the evaluation period significantly decreased in both groups compared to the dose requirements at randomization.


CONCLUSIONS
There is a possibility that s.c. administration of darbepoetin alfa is more efficacious than i.v. administration, but a definite benefit cannot be demonstrated with the current sample size. A bigger sample size is needed to confirm the result.
Kim
Chan-Duck
CD
Division of Nephrology, Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea.
Park
Sun-Hee
SH
Kim
Dae-Joong
DJ
Park
Jong-Won
JW
Do
Jun-Young
JY
Shin
Suk-Kyun
SK
Kim
Beom-Seok
BS
Seo
Jung-Ju
JJ
Kim
Yong-Lim
YL
D000740:Anemia / Q000188:drug therapy*; D000068256:Darbepoetin alfa; D004921:Erythropoietin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D007275:Injections, Intravenous; D007279:Injections, Subcutaneous; D011446:Prospective Studies; D006435:Renal Dialysis
D006454:Hemoglobins; D004921:Erythropoietin; D000068256:Darbepoetin alfa