This randomized, double-blind, placebo-controlled trial compared a strategy of initiating darbepoetin alfa at a threshold hemoglobin of 11.0 g per deciliter, with a goal of 13 g per deciliter, versus placebo, with rescue darbepoetin alfa when Hb fell below 9.0 g per deciliter. Patients studied included those with diabetes, CKD (defined as GFR 20-60 ml/min) and anemia. No difference was found in the overall rates of the primary end points. The primary endpoints were 1) death or a cardiovascular event and 2) death or end-stage renal disease.
Of particular note, the patients assigned to darbepoetin alfa had a statistically and clinically significant increase in stroke.
This study is expected to drive much discussion and influence guidelines and clinical practice.