Author/Editor     Kveder, R; Bren, AF; Varl, J
Title     Izkušnje pri kliničnem testiranju in uporabi humanega rekombinantnega eritropoetina (r-Hu-EPO)
Translated title     Experiences with clinical testing and usage of recombinant human erythropoietin (r-Hu-EPO)
Type     članek
Source     Farm Vestn
Vol. and No.     Letnik 47, št. Suppl
Publication year     1996
Volume     str. 163-71
Language     slo
Abstract     Anaemia remains one of the most common signs of chronic renal failure (CRF). The advent of recombinant human erythropoietin (r-Hu-EPO) can be considered as one of the major and most important advances over the past decade in the treatment of CRF. Authors present their experiences of short clinical trial with a use of r-Hu-EPO omega. The aim of the study was to check safety and tolerability of the drug. Thirty patients aged 23 to 85 years treated with hemodialysis or CAPD with haemoglobin concentration lower than 85 g/l participated in the trial. Epoetin omega was administered subcutaneously two to three times weekly in an average dose of 25 to 75 IU/kg of body weight. Results showed an average rise of haemoglobin concentration to target value with an average weekly dose of 93 +- 6.7 IU/kg of body weight. Only 10.7 percent did not reach the target haemoglobin concentration of 100 g/l. An important rise of reticulocytes appeared in the third week of treatment period (from 23.6 +- 3.4 to 49. +- 6 percent. Significant rise of serum concentrations of iron and feritin was observed during second month of the study. Authors did not observe any important rise of blood pressure. Allergic reaction appeared in only one patient; no other adverse effects were noticed during study period. Authors concluded that treatment of renal anaemia in patients with CRF with r-Hu-EPO omega on short term is save and effective.
Descriptors     ERYTHROPOIETIN
ANEMIA
KIDNEY FAILURE, CHRONIC
CLINICAL TRIALS
HEMOGLOBINS
BLOOD PRESSURE
IRON
FERRITIN