New studies on the use of darbepoetin alfa in non-dialysis CKD patients.


Two studies suggest once-monthly dosing of darbepoetin alfa (Aranesp, Amgen) can effectively treat CKD anemia.

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Based on a review of chart data from 34 patients with stage 3 or 4 CKD, the first study suggests that the usual protocol of administering the drug every one or two weeks may not be essential for improving CKD anemia, according to researchers Rachel Geronemus, MD, and Robert Geronemus, MD, of South Florida Nephrology Associates in Lauderdale Lakes.


Most patients were started with the standard dosage of 100 µg, with subsequent modification at a physician’s discretion. All patients received their doses once a month. The mean hemoglobin level rose from about 10.9 g/dL at baseline to 11.8 g/dL at four months. “This simplified procedure can be applied to patients treated in the office or at home,” the authors concluded.


In the second study, researchers demonstrated that once-monthly dosing of darbepoetin is not affected by baseline estimated glomerular filtration rate, diabetes status, or hemoglobin level. The study also showed that converting patients from every-other-week dosing to monthly dosing is safe and effective in managing CKD anemia.


In a third study, which analyzed data from two trials that enrolled anemic non-dialysis CKD patients not previously on erythropoietic therapy, investigators at Amgen found that starting patients on every-other-week darbepoetin dosing achieves target hemoglobin levels (11-13 g/dL) in the first eight weeks.


Few patients experienced increases in hemoglobin to levels above 13 g/dL, the upper ceiling recommended by the National Kidney Foundation. In one study, 85% of all patients who received a darbepoetin dose had a hemoglobin response, defined as a rise in hemoglobin to 11-13 g/dL. In the other study, the proportion was 92%, according to researchers.