To evaluate the clinical efficacy of recombinant human erythropoietin (EPO) and its influencing factors in the treatment of anemia in hemodialysis (HD) patients, 17 chronic stable HD patients (10 males, 7 females; mean age: 46.0 +/- 2.6 years) with severe anemia were enrolled in this study. The study period (ranging from 5 to 11 months) was divided into the initial 12 weeks of correction phase and the subsequent maintenance phase. EPO, 1500 U initially, was administered intravenously twice weekly (BIW group, n = 10) or thrice weekly (TIW group, n = 7) at the end of each HD. Dose was doubled every 4 weeks until up to a maximum dose of 6000 U if increment of hematocrit (Hct) was less than 3%. At the end of correction phase, anemia was markedly improved. Hct and hemoglobin (Hb) increased from 19.3 +/- 0.8 to 28.7 +/- 1.1% and from 6.5 +/- 0.3 to 9.6 +/- 0.4 g/dl, respectively. Fifteen patients (88%) reached to the target Hct of 30% at 13.7 +/- 1.2 weeks. At the end of study, Hct and Hb was maintained at 29.1 +/- 0.7% and 9.6 +/- 0.3 g/dl, respectively. Requirement of EPO dose to reach the target and maintain the stable Hct (greater than or equal to 28%) was 99 +/- 14 and 62 +/- 11 U/kg/week, respectively. Laboratory parameters showed that serum iron, transferrin saturation, sugar and triglyceride decreased significantly and uric acid and aluminum (Al) increased significantly. There was no significant change in predialysis blood pressure, body weight, cardiac ratio, and ECG. Quality of life was markedly improved with the better subjective feelings, physical activity and Karnorfsky index. Common adverse effects included exacerbated hypertension (23%), hyperphosphatemia (18%), hyperkalemia (18%), and flu-like syndrome (12%). All of them could be managed by medical and dialysis treatment. Investigation of influencing factors on response to EPO suggests that 1) TIW group had a better response than BIW group 2) Response was better in patients with more adequate iron status and less severe Al burden. 3) Time to target Hct correlated approximately with basal serum Al levels but did not correlate with basal serum parathyroid hormone levels. In conclusion, low dose of EPO therapy corrects anemia effectively with minimal adverse effects in HD patients. Dosing regimen, iron status, and serum Al will influence the response to EPO.