DIFFERENCES IN INTRAVENOUS AND SUBCUTANEOUS APPLICATION OF RECOMBINANT-HUMAN-ERYTHROPOIETIN - A MULTICENTER TRIAL

The aims of this clinical study were to compare the maintenance doses for intravenous (IV) and subcutaneous (SC) administration of recombina nt human erythropoietin (rhEPO) and to investigate whether there is an y difference in the increase of the packed cellular volume (PCV) per w eek under IV and SC administration of rhEPO from two production sites (Genetics Institute, Cambridge, USA; and Boehringer Mannheim, Penzberg , Germany). A total of 90 patients suffering from end-stage renal dise ase were included in the study. All patients had already been treated for at least 6 months with chronic hemodialysis. The study was carried out as a randomized, multicenter parallel group comparison study with a 1-week pretreatment phase, a subsequent 8-week double-blind phase, and a final open phase. The final open phase consisted of a correction phase and a maintenance phase. The production site had no influence o n the PCV increase per week, and there were no differences with respec t to tolerability. The median rhEPO dose required to maintain the targ et PCV of 30 to 35 vol.% was 33 U/kg body weight three times a week in the IV group compared with 22 U/kg in the SC group (i.e., an average of 30% less with SC administration). Development or aggravation of hyp ertension under rhEPO therapy was observed, especially during the corr ection phase and more frequently in the SC group than in the IV group. During the maintenance phase, there was no essential difference betwe en the two groups.