Effectiveness and safety in the use of ior® EPOCIM in predialysis patients. Clinical trial
Abstract
Introduction: The ior® EPOCIM (human recombinant erythropoietin) is a Cuban medicament produce by the Molecular Immunology Center, which result safety, not being adverse results associated to its use in dialytic patients, but regarding predialysis patients the disclosed information is not enough.
Objective: To evaluate effectiveness and safety of ior® EPOCIM in patients with Chronic Kidney Disease (CKD) in pre-dialysis, stages 3 and 4.
Material and Methods: Was performed a multicenter, opened, non-randomized phase IV clinical trial, which included 242 patients with and without anemia. During a 12 months period was evaluated the treatment with iorâ EPOCIM, with an initial dose of 30 U/kg/dose; and them increase according to the hematologic response up to a dose of 150 U/Kg/ to achieve the hemoglobin’s stabilization between 10.5-12.5 g/dL and/or hematocrit between 33-36%.
Results: The initial mean value for hemoglobin was 10 (SD ± 1.5 g / dl) it gradually increased until the 4th month stabilizing its value in 11.7 (SD ± 1.2 g / dl); hematocrit had similar behavior. Renal function remained stable. The life quality improved, was a greater benefit in the scale of the physical role and general health. 147 adverse events were reported; they had some causal relationship 13.6%. The most frequent event was hypertension (44.9%). No death was related with the product.
Conclusions: ior® EPOCIM was safe and effective in this population.
Keywords: Chronic kidney disease, predialysis, ior®EPOCIM, erythropoietin, anemia, clinical trial.
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