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Safety and Efficacy of Pdpoetin for Management of Anemia in Patients With End Stage Renal Disease on Maintenance Hemodialysis: Results From a Phase Iv Clinical Trial Publisher



Javidan AN1 ; Shahbazian H2 ; Emami A1 ; Yekaninejad MS3 ; Emamirazavi H1 ; Farhadkhani M1 ; Ahmadzadeh A4 ; Gorjipour F5
Authors
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Authors Affiliations
  1. 1. Department of Physiology and Pharmacology, Brain and Spinal Injury Center, Imam Khomeini Hospital, Tehran University of Medical Sciences, Iran
  2. 2. Division of Nephrology and Transplantation, Diabetic Research Center, Jondishapur University of Medical Sciences, Ahvaz, Iran
  3. 3. Department of Epidemiology, School of Public Health, Tehran University of Medical Sciences, Iran
  4. 4. Health Research Institute, Research Centre of Thalassemia and Hemoglobinopathies, Ahvaz Jundishapur University of Medical Sciences, Iran
  5. 5. Physiology Research Center, Iran University of Medical Sciences, Tehran, Iran

Source: Hematology Reports Published:2015


Abstract

Recombinant human erythropoietin (rHuEPO) is available for correcting anemia. PDpoetin, a new brand of rHuEPO, has been certified by Food and Drug Department of Ministry of Health and Medical Education of Iran for clinical use in patients with chronic kidney disease. We conducted this post-marketing survey to further evaluate the safety and efficacy of PDpoetin for management of anemia in patients on maintenance hemodialysis. Patients from 4 centers in Iran were enrolled for this multicenter, open-label, uncontrolled phase IV clinical trial. Changes in blood chemistry, hemoglobin and hematocrit levels, renal function, and other characteristics of the patients were recorded for 4 months; 501 of the patients recruited, completed this study. Mean age of the patients was 50.9 (±16.2) years. 48.7% of patients were female. Mean of the hemoglobin value in all of the 4 centers was 9.29 (±1.43) g/dL at beginning of the study and reached 10.96 (±2.23) g/dL after 4 months and showed significant increase overall (P<0.001). PDpoetin dose was stable at 50-100 U/kg thrice weekly. Hemorheologic disturbancesand changes in blood electrolytes was not observed. No case of immunological reactions to PDpoetin was observed. Our study, therefore, showed that PDpoetin has significantly raised the level of hemoglobin in the hemodialysis patients (about 1.7±0.6 g/dL). Anemia were successfully corrected in 49% of patients under study. Use of this biosimilar was shown to be safe and effective for the maintenance of hemoglobin in patients on maintenance hemodialysis. © A.N. Javidan et al., 2014.