만성 신부전의 빈혈에 대한 유전자 재조합 인 에리쓰로포이에틴 ( 에포론 ) 의 유효성 및 안전성 평가를 위한 연구 - 제 Ⅲ 상 임상시험

• Published in: Kidney research and clinical practice Vol. 19; no. 6; pp. 1053 - 1062
• Main Authors: 유석희, Suk Hee Yoo, 강종명, Jong Myung Kang, 강경원, Gyung Won Kang, 이호영, Ho Young Lee, 노현진, Hyun Jin Nho, 신석균, Suk Gyun Shin
• Format: Journal Article
• Language: Korean
• Published: 대한신장학회 01.11.2000
• Subjects: Anemia; Eporon; Hemodialysis; Peritoneal dialysis; Recombinant human erythropoietin
• ISSN: 2211-9132

To examine the effectiveness and safety of erythropoietin on the anemia of end-stage chronic renal failure, we administered recombinant human erythropoietin(rHuEPO), Eporon, to 66 patients with anemia and chronic renal failure who were undergoing hemodialysis or peritoneal dialysis. All received Eporon intravenously, two or three times per week at 150unit/kg, and then the dose of Eporon was adjusted to 75-300unit/kg/week according to the hemoglobin response. The results of this study judged 19(39.6%) of 48 patients as being in a "markedly improved" condition while 23(47.9%) of 48 patients were judged as being in an "improved" condition. At results, the response rate of this study was 87.5%(42/48 patients). This was the same as the target response rate, 90%(p=0.564). Serious adverse events occured in 6 cases during the study, but all proved to be unrelated to Eporon. These events included itching 1(1.5%), urticaria 1(1.5%) and headache 1(1.5%). No patients discontinued to participate in the study except one patient who withdrew from the study voluntarily. The symptoms of all adverse events eventually decreased and disappeared during the clinical study. No factors in the clinical laboratory tests changed significantly (p<0.05) except for the decrease of TSR and ferritin, a consequence of using iron hemoglobin synthesis caused by Eporon administration. The significant increase in blood pressure, which could not be proved to be related to Eporon, disappeared during the study. Anti-Epo antibody was not detected in any samples. These results demonstrate that Eporon is effective in many patients with the anemia of end-stage chronic renal failure.