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.
Abbas Norouzi Javidan, Heshmatollah Shahbazian, Amirhossein Emami, Mir Saeed Yekaninejad, Hassan Emami-Razavi, Masoumeh Farhadkhani, Ahmad Ahmadzadeh, Fazel Gorjipour
Author Information
Abbas Norouzi Javidan: Department of Physiology and Pharmacology, Brain and Spinal Injury Center, Imam Khomeini Hospital, Tehran University of Medical Sciences , Ahvaz, Iran.
Heshmatollah Shahbazian: Division of Nephrology and Transplantation, Diabetic Research Center, Jondishapur University of Medical Sciences , Ahvaz, Iran.
Amirhossein Emami: Department of Physiology and Pharmacology, Brain and Spinal Injury Center, Imam Khomeini Hospital, Tehran University of Medical Sciences , Ahvaz, Iran.
Mir Saeed Yekaninejad: Department of Epidemiology, School of Public Health, Tehran University of Medical Sciences , Tehran, Iran.
Hassan Emami-Razavi: Department of Physiology and Pharmacology, Brain and Spinal Injury Center, Imam Khomeini Hospital, Tehran University of Medical Sciences , Ahvaz, Iran.
Masoumeh Farhadkhani: Department of Physiology and Pharmacology, Brain and Spinal Injury Center, Imam Khomeini Hospital, Tehran University of Medical Sciences , Ahvaz, Iran.
Ahmad Ahmadzadeh: Health Research Institute, Research Centre of Thalassemia and Hemoglobinopathies, Ahvaz Jundishapur University of Medical Sciences , Tehran, Iran.
Fazel Gorjipour: Physiology Research Center, Faculty of Medicine, Iran University of Medical Sciences , Tehran, Iran.
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.
