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,Ahmad Ahmadzadeh,Masoumeh Farhadkhani,Amirhossein Emami,Mir Saeed Yekaninejad,Fazel Gorjipour,Hassan Emami-Razavi

doi:10.4081/hr.2014.5195

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.

Highlights

Anemia is one of the adverse outcomes in some conditions including End-Stage Renal Disease (ESRD).[1]
In patients on maintenance hemodialysis hemoglobin levels must be maintained more than 11 g/dL and hematocrit values must be maintained above 33% according to the European Best Practice Guidelines (EBPG) for the management of anemia in patients with chronic kidney disease,[19] or in the range of 11-12 g/dL according to National Kidney FoundationKidney Disease Outcome Quality Initiative guidelines (NKF-KDOQI).[20]
The Recombinant human erythropoietin (rHuEPO) provided as PDpoetin by Pouyesh Darou Pharmaceuticals, Islamic republic of Iran produced in the Chinese hamster ovary (CHO) cells

Summary

Introduction

Anemia is one of the adverse outcomes in some conditions including End-Stage Renal Disease (ESRD).[1] There are many different causes for anemia in patients on maintenance hemodialysis, among which lack of folate and B12 vitamin, gastrointestinal bleeding, iron deficiency, serious inflammations and erythropoietin deficiency are of profound importance.[2,3] When renal function is significantly impaired or if there is no other possible cause for anemia other than chronic kidney disease, erythropoietin deficiency should be considered as underlying cause of anemia. In patients on maintenance hemodialysis hemoglobin levels must be maintained more than 11 g/dL and hematocrit values must be maintained above 33% according to the European Best Practice Guidelines (EBPG) for the management of anemia in patients with chronic kidney disease,[19] or in the range of 11-12 g/dL according to National Kidney FoundationKidney Disease Outcome Quality Initiative guidelines (NKF-KDOQI).[20]

Objectives

Methods

Results

Conclusion