Hemoglobin And Hematocrit Rise In End-Stage Renal Disease (ESRD) With PDpoetin: Results Of A Phase Ш, Multicenter Clinical Trial

Abstract

Background and Objective: The anemia of ESRD is a complex disorder, associated with serious complications, which increases patients' mortality and morbidity. Treatment of this anemia with recombinant human erythropoietin (rh-EPO) is well established. This clinical trial study was conducted within 20 months, from May 2005 to December 2006, in order to evaluate the efficacy of PDpoetin (rh-EPO alpha manufactured in Iran) in anemia correction of hemodialysis patients. Materials and Methods: The study population was composed of 80 patients, aged 22-84 years (with a mean of 49.5 ± 17.5 years), who were 60% male and 40% female. Data were collected by using a questionnaire and a consent form is signed by each patient. All data analysis was carried out using SPSS software and statistical t-test. We administered 80-120 U/kg (up to 300 U/kg in resistant cases) of PDpoetin, 3 times per week, subcutaneously. Then, we followed patients by weekly blood sampling for Hct and Hgb measurement. Results: PDpoetin raised Hct>1% and Hgb>0.3 g/dl per week in 81% and 79% of patients with CRPConclusion: PDpoetin may be an appropriate substitute for imported rh-EPOs. Further research studies are recommended.