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Comparative Study of Recombinant Human Erythropoietin (rhEPO) Products on CKD (Chronic Kidney Disease) Patients

Purpose This study was conducted to evaluate whether the efficacy and safety profile of recombinant human erythropoietin (rhEPO) manufactured by Daewoong Pharmaceutical Co., Ltd was similar to biological products approved by the drug safety regulatory authority. Patients and methods It was an open-l...

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Autores principales: Dwitanto, Kuspuji, Angginy, Nova, Sutandar, Widodo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Georg Thieme Verlag 2023
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10241559/
https://www.ncbi.nlm.nih.gov/pubmed/36972619
http://dx.doi.org/10.1055/a-1982-3811
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author Dwitanto, Kuspuji
Angginy, Nova
Sutandar, Widodo
author_facet Dwitanto, Kuspuji
Angginy, Nova
Sutandar, Widodo
author_sort Dwitanto, Kuspuji
collection PubMed
description Purpose This study was conducted to evaluate whether the efficacy and safety profile of recombinant human erythropoietin (rhEPO) manufactured by Daewoong Pharmaceutical Co., Ltd was similar to biological products approved by the drug safety regulatory authority. Patients and methods It was an open-label, randomized, comparative, parallel, multi-center study in hemodialysis patients with anemia. The reference product at an individualized dose 3 times a week was given in 4–8 weeks of titration period and hemoglobin (Hb) level was controlled to reach the range of 10–12 g/dL. Then, the subjects were randomly administered with reference or test product with the same dose regimen. The primary endpoints were to demonstrate the Hb level change between baseline and evaluation period in both treatment groups, while the secondary endpoints were the mean change in weekly dosage per kg body weight and the instability rate of Hb level during maintenance and evaluation period. The safety was evaluated based on the adverse events incidence. Results There was no statistical difference in the change of Hb between test and reference (0.14 g/dL and 0.75 g/dL respectively, with p>0.05), also for the mean changes of weekly dosage between groups (1091.40 IU and 570.15 IU respectively, with p>0.05). The instability rate of Hb in both test and reference was not statistically significantly different as well (26 and 15% respectively, with p>0.05). Conclusion This study proves that the efficacy indicated by the change instability of Hb and safety indicated by adverse event incidence of Epodion and the reference product on chronic kidney disease were similar.
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spelling pubmed-102415592023-06-06 Comparative Study of Recombinant Human Erythropoietin (rhEPO) Products on CKD (Chronic Kidney Disease) Patients Dwitanto, Kuspuji Angginy, Nova Sutandar, Widodo Drug Res (Stuttg) Purpose This study was conducted to evaluate whether the efficacy and safety profile of recombinant human erythropoietin (rhEPO) manufactured by Daewoong Pharmaceutical Co., Ltd was similar to biological products approved by the drug safety regulatory authority. Patients and methods It was an open-label, randomized, comparative, parallel, multi-center study in hemodialysis patients with anemia. The reference product at an individualized dose 3 times a week was given in 4–8 weeks of titration period and hemoglobin (Hb) level was controlled to reach the range of 10–12 g/dL. Then, the subjects were randomly administered with reference or test product with the same dose regimen. The primary endpoints were to demonstrate the Hb level change between baseline and evaluation period in both treatment groups, while the secondary endpoints were the mean change in weekly dosage per kg body weight and the instability rate of Hb level during maintenance and evaluation period. The safety was evaluated based on the adverse events incidence. Results There was no statistical difference in the change of Hb between test and reference (0.14 g/dL and 0.75 g/dL respectively, with p>0.05), also for the mean changes of weekly dosage between groups (1091.40 IU and 570.15 IU respectively, with p>0.05). The instability rate of Hb in both test and reference was not statistically significantly different as well (26 and 15% respectively, with p>0.05). Conclusion This study proves that the efficacy indicated by the change instability of Hb and safety indicated by adverse event incidence of Epodion and the reference product on chronic kidney disease were similar. Georg Thieme Verlag 2023-03-27 /pmc/articles/PMC10241559/ /pubmed/36972619 http://dx.doi.org/10.1055/a-1982-3811 Text en The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/). https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License, which permits unrestricted reproduction and distribution, for non-commercial purposes only; and use and reproduction, but not distribution, of adapted material for non-commercial purposes only, provided the original work is properly cited.
spellingShingle Dwitanto, Kuspuji
Angginy, Nova
Sutandar, Widodo
Comparative Study of Recombinant Human Erythropoietin (rhEPO) Products on CKD (Chronic Kidney Disease) Patients
title Comparative Study of Recombinant Human Erythropoietin (rhEPO) Products on CKD (Chronic Kidney Disease) Patients
title_full Comparative Study of Recombinant Human Erythropoietin (rhEPO) Products on CKD (Chronic Kidney Disease) Patients
title_fullStr Comparative Study of Recombinant Human Erythropoietin (rhEPO) Products on CKD (Chronic Kidney Disease) Patients
title_full_unstemmed Comparative Study of Recombinant Human Erythropoietin (rhEPO) Products on CKD (Chronic Kidney Disease) Patients
title_short Comparative Study of Recombinant Human Erythropoietin (rhEPO) Products on CKD (Chronic Kidney Disease) Patients
title_sort comparative study of recombinant human erythropoietin (rhepo) products on ckd (chronic kidney disease) patients
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10241559/
https://www.ncbi.nlm.nih.gov/pubmed/36972619
http://dx.doi.org/10.1055/a-1982-3811
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