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Therapeutic equivalence between IOR® EPOCIM and EPO without albumin in patients in hemodyalisis with Chronic renal Insufficiency

Abstract:

A randomized, double blind, controlled, monocentric Clinical Trial Phase II-III is conducted to establish the efficacy and security of the treatment with EPO without/albumin with a new stabilizer and determine the equivalence of this formulation with the ior® EPOCIM in hemodyalized patients. 60 patients were included in iterated hemodyalisis 3 times per week, Kt/V >1,2, those who kept similar or superior levels of 10g/L of Hemoglobin during at least, for 3 months, treated with ior® EPOCIM divided in 2 groups, of 30 patients each. The first, received an EPO W/A, habitual dose of erythropoietin and the second with ior® EPOCIM, both administered s/c in doses of 1:1, no modifications in doses, evaluating the hematological response (hemoglobin, CBC) in both products. The treatment groups were homogeneous, according to the variables: for the group EPO W/A: mean age was 43.8 years, while for the group ior® EPOCIM was 46, 8 years. The media of the dry weight was of a 61,1KG vs. 60, 4 KG. Doses of erythropoietin varied only in dependence with the weight changes of the patient at the beginning and at the end of the 12 weeks. EPO W/A 7482.9 vs. 7485.4 U/KG/week and ior® EPOCIM 8045.3 vs. 8018.6 UI/KG/week. Initial results of the CBC (35, 9% vs. 36,6%) and hemoglobin (11,6 vs. 11,7 g/dl) showed that medias of CBC for both groups at the end of the study had a difference inferior to 3% (33,8 vs. 34,5) and in hemoglobin, inferior to 1 g/dl (10,6 vs. 10,7), with a slight decrease at the end of the treatment for both groups. The detected adverse effects were: pain in the site of the injection, (63%) hypotension (53, 3%), cramps (31, 7%) and headaches (15%), all attributable to the hemodyalisis process with a profile very similar to all the patients undergoing hemodyalisis. There were no statistical differences among the groups (p=0.5938). The results allow suggest the equivalence of this new product to establish its long term effects.