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Clinical |
Division of Nephrology,1 Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital, Taipei; Department of Medicine,2 School of Medicine, Fu Jen Catholic University, Taipei County, Taiwan
Correspondence to: C.H. Chang, Division of Nephrology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital, 95, Wen-Chan Road, Shih-Lin, Taipei 111, Taiwan. m001091{at}ms.skh.org.tw
Objective: Darbepoetin alfa is an
erythropoietic-stimulating protein with a threefold longer half-life than
recombinant human erythropoietin (rHuEPO) and can be used less frequently in
the treatment of renal anemia. The purpose of this single-center single-arm
study was to determine whether darbepoetin alfa, when administered at extended
dose intervals, is as effective as rHuEPO for the treatment of renal anemia in
patients on peritoneal dialysis.
Methods: Patients on peritoneal dialysis for at least 3
years receiving stable rHuEPO therapy were shifted to darbepoetin alfa
administered every week, or every other week, using the recommended 200:1
conversion factor. The doses of darbepoetin alfa were titrated to maintain
hemoglobin within ±1.0 g/dL of patients' baseline values and within a
range of 9.0 – 12.0 g/dL for up to 24 weeks (20-week dose titration
period followed by 4-week evaluation period). The primary end point was the
change in hemoglobin levels between baseline and evaluation period.
Results: 73 patients completed the study; mean age was
52.1 years; 30 males. Mean baseline and evaluation period hemoglobin levels
were similar (9.56 ± 1.11 vs 9.73 ± 1.41 g/dL, p =
0.248). Mean rHuEPO dose was 92.9 IU/kg/week (equivalent to 0.46 µg/kg/week
darbepoetin alfa), which was higher than darbepoetin alfa dose during the
evaluation period (0.46 vs 0.34 µg/kg/week, p = 0.038). In
addition, ferritin levels decreased (483 ± 26 vs 396 ± 19 ng/dL,
p = 0.014). The other parameters, such as albumin, C-reactive
protein, transferrin saturation, Kt/V, and weekly creatinine clearance showed
no statistical difference between the two regimens. No serious or major
adverse effects were observed with darbepoetin alfa during the study.
Conclusions: Using lower dosage and frequency,
darbepoetin alfa effectively maintains hemoglobin levels in peritoneal
dialysis patients previously maintained on erythropoietin beta. Similar
effects on hemoglobin can be maintained with even lower levels of ferritin
during darbepoetin alfa use. These results show that darbepoetin alfa is safe,
effective, and convenient in treating renal anemia in peritoneal dialysis
patients.
KEY WORDS: Anemia; darbepoetin alfa; erythropoietin; end-stage renal disease; chronic kidney disease.
Received 22 December 2007; accepted 8 July 2008.
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