Korean J Nephrol.
2005 May;24(3):429-440.
Randomized, Controlled Trial of Darbepoetin Alfa for the Treatment of Renal Anemia in Hemodialysis Patients
- Affiliations
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- 1Department of Internal Medicine, College of Medicine, Yonsei University, Seoul, Korea. dshan@yumc.yonsei.ac.kr
- 2The Institute of Renal Disease, College of Medicine, Yonsei University, Seoul, Korea.
- 3Department of Internal Medicine, College of Medicine, The Catholic of University, Seoul, Korea.
- 4Department of Internal Medicine, College of Medicine, Seoul National University, Seoul, Korea.
- 5Department of Internal Medicine, College of Medicine, Soonchunhyang University, Seoul, Korea.
- 6Department of Internal Medicine, College of Medicine, University of Ulsan, Seoul, Korea.
- 7Department of Internal Medicine, College of Medicine, Kwandong University, Goyang, Korea.
Abstract
- BACKGROUND
Darbepoetin alfa is a new erythropoietic agent with a three fold longer terminal half-life than recombinant human erythropoietin (r- HuEPO). The aim of this randomized, open-label study is to determine whether darbepoetin alfa is as effective as r-HuEPO for the treatment of anemia in hemodialysis patients when administered at a reduced dosing frequency. METHODS: A total 74 Korean hemodialysis patients receiving r-HuEPO therapy by either the intravenous (IV) or subcutaneous (SC) route were randomized to continue r-HuEPO or to receive an equivalent dose of darbepoetin alfa at a reduced dosing frequency. Patients receiving r-HuEPO once weekly changed to once every other week darbepoetin alfa, and those receiving r-HuEPO two or three times weekly changed to once-weekly darbepoetin alfa. The initial dose of darbepoetin alfa was based on the r-HuEPO dose at the time of entry into the study, using a formula equating the peptide mass of the two molecules (200 IU r-HuEPO=1 microgram darbepoetin alfa). The doses of r-HuEPO and darbepoetin alfa were titrated to maintain hemoglobin concentrations within -1.0 to +1.5 g/dL of patients' baseline values and within a range of 8.0 to 13.0 g/ dL for up to 20 weeks (16-week dose-titration period followed by a 4-week evaluation period). The primary end point was change in hemoglobin level between baseline and the evaluation period. RESULTS: The mean change in hemoglobin from baseline to the evaluation period was similar in the darbepoetin alfa (-0.03+/-0.19 g/dL) and r-HuEPO (0.27+/-0.20 g/dL) groups, and the difference between the two treatments was -0.30 g/dL (95% CI, -0.84 to 0.23). This was not a statistically significant or clinically relevant difference, despite the reduced frequency of darbepoetin alfa administration. The safety profiles of darbepoetin alfa and r-HuEPO were similar. CONCLUSION: This study suggests that darbepoetin alfa maintains hemoglobin as effectively as r- HuEPO, but with reduced dose frequency.
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