Objective. To demonstrate the efficacy and safety of once-monthly (QM) darbepoetin alfa administration in maintaining haemoglobin (Hb) 11.0-13.0 g dL )1 in subjects with chronic kidney disease (CKD) not receiving dialysis and previously treated with darbepoetin alfa every other week (Q2W).Subjects. This open-label study enrolled subjects ‡18 years of age who had glomerular filtration rate ‡15 and £60 mL min )1 /1.73 m 2 , had Hb 11.0-13.0 g dL )1 , and were receiving Q2W darbepoetin alfa. Design. Subjects were switched to QM darbepoetin alfa therapy for 28 weeks; the QM dose was titrated to maintain Hb levels. Primary end-point:proportion of subjects maintaining Hb ‡11.0 g dL )1 during the final 8 weeks of the study (evaluation phase). Secondary end-points: Hb concentration during evaluation, darbepoetin alfa dose during the study, adverse events, laboratory parameters, and blood pressure. Results. The study enrolled 152 subjects (female 52%, white 64%). Mean Hb ‡11.0 g dL )1 during evaluation was achieved by 76% of the 150 subjects who received at least one dose of darbepoetin alfa [95% confidence interval (CI): 68%, 83%]. Mean (SD) Hb during evaluation was 11.71 (0.92) g dL )1 . Eighty-five per cent of 129 subjects who completed the study (95% CI: 78%, 91%) had Hb ‡11.0 g dL )1 during evaluation. The dose of darbepoetin alfa over the study period was median (95% CI) 124.4 lg (106.2, 140.0). Darbepoetin alpha administered QM was well tolerated in study subjects. Conclusion. Darbepoetin alpha administered QM maintained Hb in study subjects with CKD not receiving dialysis.