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 withrecombinant 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.