A multicentre, multi-national, double-blind, randomised, active-controlled, parallel-group clinical study to assess the safety and efficacy of PDA10 (Epoetin-alpha) vs. Eprex® in patients with anaemia of chronic renal failure

Abstract Background Erythropoietin stimulating agent (ESA) has been standard of care in treating renal anaemia for the past 20 years. Many patients have limited access to ESA in view of long-term costs leading to suboptimal ESA dosage. Biosimilar epoetin is a potential cost-effective alternative to...

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Autores principales:	Soo Kun Lim, Bak Leong Goh, Ravindran Visvanathan, Su Hyun Kim, Jin Seok Jeon, Sung Gyun Kim, Jae Hyun Chang, Chun Soo Lim, Zaki Morad
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Anaemia Epoetin-α Haemodialysis PDA10 Therapeutic equivalence Diseases of the genitourinary system. Urology RC870-923
Acceso en línea:	https://doaj.org/article/a13faceccad049b6924089674f593de5
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spelling	oai:doaj.org-article:a13faceccad049b6924089674f593de52021-11-28T12:41:22ZA multicentre, multi-national, double-blind, randomised, active-controlled, parallel-group clinical study to assess the safety and efficacy of PDA10 (Epoetin-alpha) vs. Eprex® in patients with anaemia of chronic renal failure10.1186/s12882-021-02601-w1471-2369https://doaj.org/article/a13faceccad049b6924089674f593de52021-11-01T00:00:00Zhttps://doi.org/10.1186/s12882-021-02601-whttps://doaj.org/toc/1471-2369Abstract Background Erythropoietin stimulating agent (ESA) has been standard of care in treating renal anaemia for the past 20 years. Many patients have limited access to ESA in view of long-term costs leading to suboptimal ESA dosage. Biosimilar epoetin is a potential cost-effective alternative to originator for optimal renal anaemia management. Objective To determine efficacy and safety of PDA10 in treating renal anaemia in haemodialysis patients, in comparison to the originator epoetin-α, Eprex®. Methods A phase 3, multicentre, multi-national, double-blind, randomised, active-controlled and parallel group study conducted over 40 weeks in Malaysia and Korea. End stage kidney disease patients undergoing regular haemodialysis who were on erythropoietin treatment were recruited. The study has 3 phases, which included a 12-week titration phase, followed by 28-week double-blind treatment phase and 24-week open-label extension phase. Results The PDA10 and Eprex® were shown to be therapeutically equivalent (p < 0.0001) with mean absolute change in haemoglobin from baseline of − 0.176 (± 0.91) g/dl and − 0.118 (± 1.114) g/dl, respectively. Weekly dose change was 10.01 IU/kg/week in PDA10 group and 10.30 IU/kg/week in Eprex® group, which has no significant difference. There were no significant differences in the safety profile between PDA10 and Eprex® groups. Conclusion This study has confirmed the therapeutic equivalence between PDA10 and Eprex® in terms of efficacy, dosage requirement and safety profile in haemodialysis patients with renal anaemia. Trial registration The study was registered with the National Medical Research Register ( NMRR-13-400-16313 ). This study has been registered retrospectively with Clinical Research Information Service ( CRiS ), Republic of Korea on 25 March 2021.Soo Kun LimBak Leong GohRavindran VisvanathanSu Hyun KimJin Seok JeonSung Gyun KimJae Hyun ChangChun Soo LimZaki MoradBMCarticleAnaemiaEpoetin-αHaemodialysisPDA10Therapeutic equivalenceDiseases of the genitourinary system. UrologyRC870-923ENBMC Nephrology, Vol 22, Iss 1, Pp 1-10 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Anaemia Epoetin-α Haemodialysis PDA10 Therapeutic equivalence Diseases of the genitourinary system. Urology RC870-923
spellingShingle	Anaemia Epoetin-α Haemodialysis PDA10 Therapeutic equivalence Diseases of the genitourinary system. Urology RC870-923 Soo Kun Lim Bak Leong Goh Ravindran Visvanathan Su Hyun Kim Jin Seok Jeon Sung Gyun Kim Jae Hyun Chang Chun Soo Lim Zaki Morad A multicentre, multi-national, double-blind, randomised, active-controlled, parallel-group clinical study to assess the safety and efficacy of PDA10 (Epoetin-alpha) vs. Eprex® in patients with anaemia of chronic renal failure
description	Abstract Background Erythropoietin stimulating agent (ESA) has been standard of care in treating renal anaemia for the past 20 years. Many patients have limited access to ESA in view of long-term costs leading to suboptimal ESA dosage. Biosimilar epoetin is a potential cost-effective alternative to originator for optimal renal anaemia management. Objective To determine efficacy and safety of PDA10 in treating renal anaemia in haemodialysis patients, in comparison to the originator epoetin-α, Eprex®. Methods A phase 3, multicentre, multi-national, double-blind, randomised, active-controlled and parallel group study conducted over 40 weeks in Malaysia and Korea. End stage kidney disease patients undergoing regular haemodialysis who were on erythropoietin treatment were recruited. The study has 3 phases, which included a 12-week titration phase, followed by 28-week double-blind treatment phase and 24-week open-label extension phase. Results The PDA10 and Eprex® were shown to be therapeutically equivalent (p < 0.0001) with mean absolute change in haemoglobin from baseline of − 0.176 (± 0.91) g/dl and − 0.118 (± 1.114) g/dl, respectively. Weekly dose change was 10.01 IU/kg/week in PDA10 group and 10.30 IU/kg/week in Eprex® group, which has no significant difference. There were no significant differences in the safety profile between PDA10 and Eprex® groups. Conclusion This study has confirmed the therapeutic equivalence between PDA10 and Eprex® in terms of efficacy, dosage requirement and safety profile in haemodialysis patients with renal anaemia. Trial registration The study was registered with the National Medical Research Register ( NMRR-13-400-16313 ). This study has been registered retrospectively with Clinical Research Information Service ( CRiS ), Republic of Korea on 25 March 2021.
format	article
author	Soo Kun Lim Bak Leong Goh Ravindran Visvanathan Su Hyun Kim Jin Seok Jeon Sung Gyun Kim Jae Hyun Chang Chun Soo Lim Zaki Morad
author_facet	Soo Kun Lim Bak Leong Goh Ravindran Visvanathan Su Hyun Kim Jin Seok Jeon Sung Gyun Kim Jae Hyun Chang Chun Soo Lim Zaki Morad
author_sort	Soo Kun Lim
title	A multicentre, multi-national, double-blind, randomised, active-controlled, parallel-group clinical study to assess the safety and efficacy of PDA10 (Epoetin-alpha) vs. Eprex® in patients with anaemia of chronic renal failure
title_short	A multicentre, multi-national, double-blind, randomised, active-controlled, parallel-group clinical study to assess the safety and efficacy of PDA10 (Epoetin-alpha) vs. Eprex® in patients with anaemia of chronic renal failure
title_full	A multicentre, multi-national, double-blind, randomised, active-controlled, parallel-group clinical study to assess the safety and efficacy of PDA10 (Epoetin-alpha) vs. Eprex® in patients with anaemia of chronic renal failure
title_fullStr	A multicentre, multi-national, double-blind, randomised, active-controlled, parallel-group clinical study to assess the safety and efficacy of PDA10 (Epoetin-alpha) vs. Eprex® in patients with anaemia of chronic renal failure
title_full_unstemmed	A multicentre, multi-national, double-blind, randomised, active-controlled, parallel-group clinical study to assess the safety and efficacy of PDA10 (Epoetin-alpha) vs. Eprex® in patients with anaemia of chronic renal failure
title_sort	multicentre, multi-national, double-blind, randomised, active-controlled, parallel-group clinical study to assess the safety and efficacy of pda10 (epoetin-alpha) vs. eprex® in patients with anaemia of chronic renal failure
publisher	BMC
publishDate	2021
url	https://doaj.org/article/a13faceccad049b6924089674f593de5
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A multicentre, multi-national, double-blind, randomised, active-controlled, parallel-group clinical study to assess the safety and efficacy of PDA10 (Epoetin-alpha) vs. Eprex® in patients with anaemia of chronic renal failure

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