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International Journal of Cell Cloning, Vol 6, 179-191, Copyright © 1988 by AlphaMed Press
ORIGINAL ARTICLES |
A Urabe, F Takaku, H Mizoguchi, K Kubo, K Ota, N Shimizu, K Tanaka, N Mimura, H Nihei and S Koshikawa
Third Department of Internal Medicine, Faculty of Medicine, University of Tokyo, Japan.
Phase I and Phase II studies of recombinant human erythropoietin (rhEpo) were conducted in normal volunteers and in anemic patients with chronic renal failure on maintenance hemodialysis. Three hundred U/person of rhEpo was administered intravenously to healthy normal volunteers in the Phase I study, resulting in no subjective or objective changes. In the Phase II study, 66 patients with chronic renal failure on maintenance hemodialysis with less than 20% hematocrit values were treated with rhEpo in doses of 50 U/kg to 200 U/kg two or three times a week. Hematocrit values increased significantly during the 12 weeks, and the patients' conditions improved. Patients previously requiring blood transfusions became transfusion-independent during our study. There were no obvious side effects, thus indicating the safety and efficacy of rhEpo in the anemia of chronic renal failure.
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