Clinical Trial Evaluating Efficacy and Safety of Recombinant Human Erythropoietin(Espogen(R)) in Dialysis Patients / 대한신장학회잡지

ABSTRACT

We conducted a multicenter clinical trial to evaluate the efficacy and safety of recombinant human erythropoietin(Espogen(R), LG Chemical Ltd.) in the anemic patients of chronic renal failure undergoing dialysis. The patients were end-stage renal disease who were undergoing hemodialysis or peritonea1 dialysis for 3 months or longer and they had less than 8g/dL of hemoglobin and more than 100ng/mL of serum ferritin. Hemodialysis patients were administered 150unit/kg/week of recombinant human erythropoietin as initial dose, and peritoneal dialysis patients 50unitAg, twice per week. We examined hemoglobin value every other week and adjusted the dose in order to maintain hemoglobin level as 10-llg/dL. We enrolled 64 patients and analysed 54 cases in the final. 96.3% (52/54) of patients showed increase by more than 1.0g/dL and the others in- crease by more than 0.5g/dL. Baseline hemoglobin, hematocrit were 7.11+/-0.85g/dL, 21.3+/-2.6% and final level were 10.42+/-1.31g/dL, 31.9+/-3.5%(p=0.0001), respectively. Reticulocyte was increased after 2 weeks of administration from 0.90+/-0.74% to 2.45+/-0.84% The adverse effects included hypertension, headache, increased potassium and phosphate level so required regular monitoring. Therefore we showed that Es-pogen was effective in correcting the anemia of chronic renal failure and didn't have any particular adverse effects.