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Randomized trial to compare the dosage of darbepoetin alfa by administration route in haemodialysis patients.

作者信息

Kim Chan-Duck, Park Sun-Hee, Kim Dae-Joong, Park Jong-Won, Do Jun-Young, Shin Suk-Kyun, Kim Beom-Seok, Seo Jung-Ju, Kim Yong-Lim

机构信息

Division of Nephrology, Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea.

出版信息

Nephrology (Carlton). 2009 Aug;14(5):482-7. doi: 10.1111/j.1440-1797.2008.01067.x. Epub 2009 Mar 10.

DOI:10.1111/j.1440-1797.2008.01067.x
PMID:19298639
Abstract

AIM

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.

CONCLUSION

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.

摘要

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Darbepoetin for the anaemia of chronic kidney disease.
达贝泊汀用于治疗慢性肾脏病贫血
Cochrane Database Syst Rev. 2014 Mar 31;2014(3):CD009297. doi: 10.1002/14651858.CD009297.pub2.