Hemoglobin and Hematocrit Rise in End-Stage Renal Disease (ESRD) with PDpoetin: Results of a Phase III, Multicenter Clinical Trial

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 (rHu-EPO) is well established. This clinical trial study was conducted within 20 months, from May 2005 to January 2007, in order to evaluate the efficacy of PDpoetin (rHu-EPO 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 were carried out using SPSS software and statistical t-test. We administered 50-100 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 CRP 5 mg/dl, respectively. In patients with CRP2:5 mg/dl, these values were 56% and 54%. The mean values of Hct and Hgb rise per week were 1.4 ± 0.2% and 0.4 ± 0.06 g/dl (p = 0.0004 and p = 0.0002, respectively), without any statistically significant difference in both gender. Conclusion: PDpoetin may be an appropriate substitute for commersially availabele rHuEPOs(Eprex). Further research studies are ecommended.