Phase III Clinical Trial Evaluating Efficacy and Safety of Recombinant Human Erythropoietin(Epokine(R)) in Hemodialysis Patients

Lee, In Hee; Shin, Sug Kyun; Kang, Shin Wook; Noh, Hyun Jin; Seo, Bo Jeong; Park, Hyeong Cheon; Choi, Kyu Hun; Ha, Sung Kyu; Lee, Ho Yung; Han, Dae Suk; Lee, Eun Young; Kang, Duk Hee; Choi, Gyu Bog; Yoon, Kyun Il

Abstract

To evaluate the clinical efficacy and safety of newly developed recombinant human erythropoietin (Epokine(R)), a phase III clinical trial was performed in patients with end-stage renal disease undergoing maintenance hemodialysis. Epokine(R)was given initially at a dosage of 50unit/kg, intravenously, three times a week after each dialysis session and the dosage was adjusted according to the changes in hemoglobin level. Out of total 79 patients who were enrolled initially, data of 64 patients who have completed 12 weeks study period were analyzed. The results were as following: 1) Hemoglobin(g/dL) and hematocrit(%) increased significantly from baseline levels beginning from 2 weeks after Epokine(R) administration. Hemoglobin increased significantly from 6.8+/-0.8 to 10.4+/-1.3 and hematocrit increased significantly from 20.9+/-2.2 to 31.1+/-5.2 after 12 weeks(P<0.05). Corrected reticulocyte count(%) increased significantly from 0.6+/-0.4 to 1.4+/-0.7 after 2 weeks and to 1.3+/-0.6 after 12 weeks(P<0.05). 2) A significant increase in platelet count was observed from 2 weeks after Epokine(R) administration (P<0.05). 3) Serum ferritin and serum iron decreased significantly and total iron binding capacity increased significantly after 2 weeks(P<0.05). 4) The mean of pre-hemodialysis systolic blood pressure(mmHg) increased significantly from 148+/-21 to 154+/-25 at 12 weeks(P<0.05). Also, post-hemodialysis blood pressure(systolic/diastolic) at 12 weeks increased significantly from baseline levels(146+/-28/ 82+/-15 vs. 153+/-25/87+/-14mmHg, P<0.05). 5) Anti-erythropoietin antibody was not detected in all subjects. 6) Side effects observed in this study were similar to those reported by earlier reports. Headache(9 cases), and flu-like syndrome(7 cases) were the most common side effects. These side effects were not severe and disappeared without discontinuation of Epokine(R) administration in most of the patients. In conclusion, Epokine(R) is safe and effective in treating anemia of hemodialysis patients with end stage renal disease.