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
| Autor: | Abbas Norouzi Javidan, Heshmatollah Shahbazian, Amirhossein Emami, Mir Saeed Yekaninejad, Hassan Emami-Razavi, Masoumeh Farhadkhani, Ahmad Ahmadzadeh, Fazel Gorjipour |
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| Jazyk: | angličtina |
| Rok vydání: | 2014 |
| Předmět: | |
| Zdroj: | Hematology Reports, Vol 6, Iss 3 (2014) |
| Druh dokumentu: | article |
| ISSN: | 2038-8322 2038-8330 |
| DOI: | 10.4081/hr.2014.5195 |
| Popis: | 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 |
| Databáze: | Directory of Open Access Journals |
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