Repository of Research and Investigative Information

Repository of Research and Investigative Information

Ahvaz Jundishapur University of Medical Sciences

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

Javidan, A. N. and Shahbazian, H. and Emami, A. and Yekaninejad, M. S. and Emami-Razavi, H. and Farhadkhani, M. and Ahmadzadeh, A. and Gorjipour, F. (2015) 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. Hematology reports, 6 (3). pp. 40-44. ISSN 20388322 (ISSN)

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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.

Item Type: Article
Keywords: Anemia/drug therapy Chronic/complications Epoetin alfa Kidney failure Recombinant proteins Renal dialysis erythropoietin antibody ferritin hemoglobin iron recombinant erythropoietin transferrin absence of side effects adult anemia Article diet drug dose increase drug dose titration drug efficacy drug safety drug treatment failure electrolyte blood level end stage renal disease fatigue female ferritin blood level fever headache hematocrit hematologic disease hemodialysis hemoglobin blood level human hypertension immunity immunoassay injection site contusion injection site inflammation injection site pain iron metabolism kidney function lethargy loading drug dose major clinical study male multicenter study myalgia open study phase 4 clinical trial postmarketing surveillance pure red cell anemia vertigo
Subjects: R Medicine > R Medicine (General)
Divisions: Faculty of Medicine, Health and Life Sciences
Depositing User: مهندس مهدی شریفی
Last Modified: 01 Jun 2018 11:32
URI: http://eprints.ajums.ac.ir/id/eprint/16532

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