An observational study of the effectiveness of darbepoetin alpha administered in dialysis patients once every 2 weeks for 12 months.

Aims: Erythropoiesis-stimulating agents (ESA S ) are recommended for managing renal anemia. ALTERNATE is an observational study in European and Australian dialysis patients evaluating darbepoetin α (DA) once every 2 weeks (Q2W) in clinical practice. Methods: Adult dialysis patients initiating treatment with DA Q2W were eligible regardless of previous/current ESA use. Data were collected 6 months before and 12 months after Q2W initiation. The primary endpoint was hemoglobin (Hb) concentration 12 months after initiation. Results: A total of 6,112 patients were enrolled; 6,104 were eligible (87% hemodialysis, 12% peritoneal dialysis). Before initiation, 77.3%, 8.8%, and 7.8% of patients were receiving DA, epoetin β, and epoetin α, respectively; 6% were ESA naive. Mean (95% CI) Hb (g/dl) was 11.68 (11.63 - 11.72) 6 months before initiation, 12.00 (11.97 ― 12.04) at initiation, and 11.62 (11.58 - 11.66) 12 months after initiation. Geometric mean (95% CI) weekly ESA dose (μg/wk) was 27.27 (26.62 ― 27.93) immediately before initiation, 23.69 (23.28 - 24.10) at initiation, and 26.80 (26.12 - 27.49) 12 months after initiation. At month 12, 77.3% of patients were receiving DA Q2W. Conclusions: This large observational study demonstrates that Hb concentrations can be effectively maintained over 12 months in a general dialysis population with DA Q2W without an increase in ESA dose.