Clinical trials have clearly demonstrated the efficacy of recombinant human erythropoietin (r-HuEPO) (EPOGEN [epoetin alfa]; AMGEN Inc, Thousand Oaks, CA) in the treatment of the anemia associated with end-stage renal disease (ESRD). Nearly all dialysis patients treated with r-HuEPO have responded by reaching target hematocrit levels within 8 to 12 weeks. Maintenance therapy has been effective, and some patients have had stable blood counts for greater than 2 years. The drug has been well tolerated, has resulted in elimination of transfusion dependency, and has evoked no antibody formation. Significant management issues include maintenance of sufficient iron stores to sustain red cell production and the control of blood pressure (BP) elevation associated with increased peripheral vascular resistance resulting from rising hematocrit (HCT) levels. Preliminary results of quality-of-life assessments confirm the beneficial effects of r-HuEPO therapy. This drug should become standard therapy for patients with the anemia of ESRD.