A nemia is a “classic” compli- cation of advanced chronic kidney disease (CKD) and used to constitute a major unmet need in that no effective chronic treat- ments were available. In 1988, roughly 75% of dialysis patients had a hematocrit of < 30%. 1 The ensuing symptom burden led to the frequent administration of blood transfusions, often resulting in systemic iron overload, espe- cially in persons undergoing maintenance hemodialysis. In 1989, this changed dramatically with the introduction of the bio- logic, epoetin alfa, a first-in-class erythropoiesis-stimulating agent (ESA) that was approved via an orphan drug designation for the indication, “to elevate the red blood cell level [.] and to decrease the need for transfusions [.].” 2 Subsequent uptake of ESAs was rapid, facilitated by a coverage determination from Medicare, and ESAs have since been a cornerstone of anemia treatment in persons with advanced CKD including those on dialysis.
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