Effect of recombinant human erythropoietin on the anemia of chronic renal failure.
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.
Urabe
A
A
Third Department of Internal Medicine, Faculty of Medicine, University of Tokyo, Japan.
Takaku
F
F
Mizoguchi
H
H
Kubo
K
K
Ota
K
K
Shimizu
N
N
Tanaka
K
K
Mimura
N
N
Nihei
H
H
Koshikawa
S
S
D000328:Adult; D000740:Anemia / Q000188:drug therapy* / Q000209:etiology; D004341:Drug Evaluation / Q000592:standards; D004921:Erythropoietin / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007668:Kidney / Q000187:drug effects / Q000503:physiopathology; D007676:Kidney Failure, Chronic / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use*
D011994:Recombinant Proteins; D004921:Erythropoietin