Efficacy and Safety of CKD-11101 (Proposed Biosimilar of Darbepoetin-Alfa) Compared with Darbepoetin-Alfa in Patients on Hemodialysis: A Randomized, Double-Blinded, Parallel-Group Phase III Study

Yaerim Kim, Su Kil Park, Won Yong Cho, Kwon Wook Joo, Sug Kyun Shin, Dae Joong Kim, Yong Lim Kim, Sung Hyun Son, Wookyung Chung, Kwang Young Lee, Sung Kwang Park, Joong Kyung Kim, Soo Wan Kim, Duk Hee Kang, Jin Kuk Kim, Jin Seok Jeon, Kang Wook Lee, Chang Hwa Lee, Dong Jin Oh, Won Suk AnJong Soo Lee, Gun Woo Kang, Jun young Do, Jung Pyo Lee, Kyubok Jin

Research output: Contribution to journalArticle

Abstract

Background: Darbepoetin-alfa is an erythropoiesis-stimulating agent (ESA) with a long elimination half-life that achieves better hemoglobin (Hb) stability than short-acting ESAs. Objective: We aimed to evaluate the efficacy and safety of intravenous CKD-11101 (a biosimilar of darbepoetin-alfa) compared with those of darbepoetin-alfa in hemodialysis patients. Methods: The study was performed in 24 centers in Korea between June 2015 and June 2017. The study subjects were randomized in a double-blind manner. The follow-up duration was 24 weeks, which consisted of 20 weeks of maintenance and 4 weeks of evaluation period. All patients underwent a stabilization period to achieve a target baseline Hb of 10–12 g/dL before randomization. Following randomization, patients received darbepoetin-alfa or CKD-11101 weekly or biweekly. Results: A total of 403 patients were randomized into two groups, and a total of 325 patients (80.6%) completed the investigation. The differences between the two groups in terms of change in the average Hb level from baseline to evaluation were not significant. The average administered dose of ESA was similar between the groups. There was no difference in the proportion of patients who maintained the target Hb during the evaluation period [60.4% vs. 66.2% in the CKD-11101 and darbepoetin-alfa groups, respectively (p = 0.3038)]. In addition, the safety analysis, consisting of adverse events and adverse drug reactions, showed comparable results between the two groups. Conclusion: The changes in the level of Hb, dose of erythropoietin, and achievement rate of the target Hb during the study period were comparable between the groups. CKD-11101 has an equivalent efficacy and safety compared with darbepoetin-alfa in patients undergoing hemodialysis.

Original languageEnglish
Pages (from-to)99-110
Number of pages12
JournalBioDrugs
Volume34
Issue number1
DOIs
Publication statusPublished - 2020 Feb 1

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Biosimilar Pharmaceuticals
Renal Dialysis
Hemoglobins
Safety
Hematinics
Random Allocation
Korea
Erythropoietin
Darbepoetin alfa
Drug-Related Side Effects and Adverse Reactions
Half-Life
Maintenance

ASJC Scopus subject areas

  • Biotechnology
  • Pharmacology
  • Pharmacology (medical)

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Efficacy and Safety of CKD-11101 (Proposed Biosimilar of Darbepoetin-Alfa) Compared with Darbepoetin-Alfa in Patients on Hemodialysis : A Randomized, Double-Blinded, Parallel-Group Phase III Study. / Kim, Yaerim; Park, Su Kil; Cho, Won Yong; Joo, Kwon Wook; Shin, Sug Kyun; Kim, Dae Joong; Kim, Yong Lim; Son, Sung Hyun; Chung, Wookyung; Lee, Kwang Young; Park, Sung Kwang; Kim, Joong Kyung; Kim, Soo Wan; Kang, Duk Hee; Kim, Jin Kuk; Jeon, Jin Seok; Lee, Kang Wook; Lee, Chang Hwa; Oh, Dong Jin; An, Won Suk; Lee, Jong Soo; Kang, Gun Woo; Do, Jun young; Lee, Jung Pyo; Jin, Kyubok.

In: BioDrugs, Vol. 34, No. 1, 01.02.2020, p. 99-110.

Research output: Contribution to journalArticle

Kim, Y, Park, SK, Cho, WY, Joo, KW, Shin, SK, Kim, DJ, Kim, YL, Son, SH, Chung, W, Lee, KY, Park, SK, Kim, JK, Kim, SW, Kang, DH, Kim, JK, Jeon, JS, Lee, KW, Lee, CH, Oh, DJ, An, WS, Lee, JS, Kang, GW, Do, JY, Lee, JP & Jin, K 2020, 'Efficacy and Safety of CKD-11101 (Proposed Biosimilar of Darbepoetin-Alfa) Compared with Darbepoetin-Alfa in Patients on Hemodialysis: A Randomized, Double-Blinded, Parallel-Group Phase III Study', BioDrugs, vol. 34, no. 1, pp. 99-110. https://doi.org/10.1007/s40259-019-00396-9
Kim, Yaerim ; Park, Su Kil ; Cho, Won Yong ; Joo, Kwon Wook ; Shin, Sug Kyun ; Kim, Dae Joong ; Kim, Yong Lim ; Son, Sung Hyun ; Chung, Wookyung ; Lee, Kwang Young ; Park, Sung Kwang ; Kim, Joong Kyung ; Kim, Soo Wan ; Kang, Duk Hee ; Kim, Jin Kuk ; Jeon, Jin Seok ; Lee, Kang Wook ; Lee, Chang Hwa ; Oh, Dong Jin ; An, Won Suk ; Lee, Jong Soo ; Kang, Gun Woo ; Do, Jun young ; Lee, Jung Pyo ; Jin, Kyubok. / Efficacy and Safety of CKD-11101 (Proposed Biosimilar of Darbepoetin-Alfa) Compared with Darbepoetin-Alfa in Patients on Hemodialysis : A Randomized, Double-Blinded, Parallel-Group Phase III Study. In: BioDrugs. 2020 ; Vol. 34, No. 1. pp. 99-110.
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abstract = "Background: Darbepoetin-alfa is an erythropoiesis-stimulating agent (ESA) with a long elimination half-life that achieves better hemoglobin (Hb) stability than short-acting ESAs. Objective: We aimed to evaluate the efficacy and safety of intravenous CKD-11101 (a biosimilar of darbepoetin-alfa) compared with those of darbepoetin-alfa in hemodialysis patients. Methods: The study was performed in 24 centers in Korea between June 2015 and June 2017. The study subjects were randomized in a double-blind manner. The follow-up duration was 24 weeks, which consisted of 20 weeks of maintenance and 4 weeks of evaluation period. All patients underwent a stabilization period to achieve a target baseline Hb of 10–12 g/dL before randomization. Following randomization, patients received darbepoetin-alfa or CKD-11101 weekly or biweekly. Results: A total of 403 patients were randomized into two groups, and a total of 325 patients (80.6{\%}) completed the investigation. The differences between the two groups in terms of change in the average Hb level from baseline to evaluation were not significant. The average administered dose of ESA was similar between the groups. There was no difference in the proportion of patients who maintained the target Hb during the evaluation period [60.4{\%} vs. 66.2{\%} in the CKD-11101 and darbepoetin-alfa groups, respectively (p = 0.3038)]. In addition, the safety analysis, consisting of adverse events and adverse drug reactions, showed comparable results between the two groups. Conclusion: The changes in the level of Hb, dose of erythropoietin, and achievement rate of the target Hb during the study period were comparable between the groups. CKD-11101 has an equivalent efficacy and safety compared with darbepoetin-alfa in patients undergoing hemodialysis.",
author = "Yaerim Kim and Park, {Su Kil} and Cho, {Won Yong} and Joo, {Kwon Wook} and Shin, {Sug Kyun} and Kim, {Dae Joong} and Kim, {Yong Lim} and Son, {Sung Hyun} and Wookyung Chung and Lee, {Kwang Young} and Park, {Sung Kwang} and Kim, {Joong Kyung} and Kim, {Soo Wan} and Kang, {Duk Hee} and Kim, {Jin Kuk} and Jeon, {Jin Seok} and Lee, {Kang Wook} and Lee, {Chang Hwa} and Oh, {Dong Jin} and An, {Won Suk} and Lee, {Jong Soo} and Kang, {Gun Woo} and Do, {Jun young} and Lee, {Jung Pyo} and Kyubok Jin",
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T1 - Efficacy and Safety of CKD-11101 (Proposed Biosimilar of Darbepoetin-Alfa) Compared with Darbepoetin-Alfa in Patients on Hemodialysis

T2 - A Randomized, Double-Blinded, Parallel-Group Phase III Study

AU - Kim, Yaerim

AU - Park, Su Kil

AU - Cho, Won Yong

AU - Joo, Kwon Wook

AU - Shin, Sug Kyun

AU - Kim, Dae Joong

AU - Kim, Yong Lim

AU - Son, Sung Hyun

AU - Chung, Wookyung

AU - Lee, Kwang Young

AU - Park, Sung Kwang

AU - Kim, Joong Kyung

AU - Kim, Soo Wan

AU - Kang, Duk Hee

AU - Kim, Jin Kuk

AU - Jeon, Jin Seok

AU - Lee, Kang Wook

AU - Lee, Chang Hwa

AU - Oh, Dong Jin

AU - An, Won Suk

AU - Lee, Jong Soo

AU - Kang, Gun Woo

AU - Do, Jun young

AU - Lee, Jung Pyo

AU - Jin, Kyubok

PY - 2020/2/1

Y1 - 2020/2/1

N2 - Background: Darbepoetin-alfa is an erythropoiesis-stimulating agent (ESA) with a long elimination half-life that achieves better hemoglobin (Hb) stability than short-acting ESAs. Objective: We aimed to evaluate the efficacy and safety of intravenous CKD-11101 (a biosimilar of darbepoetin-alfa) compared with those of darbepoetin-alfa in hemodialysis patients. Methods: The study was performed in 24 centers in Korea between June 2015 and June 2017. The study subjects were randomized in a double-blind manner. The follow-up duration was 24 weeks, which consisted of 20 weeks of maintenance and 4 weeks of evaluation period. All patients underwent a stabilization period to achieve a target baseline Hb of 10–12 g/dL before randomization. Following randomization, patients received darbepoetin-alfa or CKD-11101 weekly or biweekly. Results: A total of 403 patients were randomized into two groups, and a total of 325 patients (80.6%) completed the investigation. The differences between the two groups in terms of change in the average Hb level from baseline to evaluation were not significant. The average administered dose of ESA was similar between the groups. There was no difference in the proportion of patients who maintained the target Hb during the evaluation period [60.4% vs. 66.2% in the CKD-11101 and darbepoetin-alfa groups, respectively (p = 0.3038)]. In addition, the safety analysis, consisting of adverse events and adverse drug reactions, showed comparable results between the two groups. Conclusion: The changes in the level of Hb, dose of erythropoietin, and achievement rate of the target Hb during the study period were comparable between the groups. CKD-11101 has an equivalent efficacy and safety compared with darbepoetin-alfa in patients undergoing hemodialysis.

AB - Background: Darbepoetin-alfa is an erythropoiesis-stimulating agent (ESA) with a long elimination half-life that achieves better hemoglobin (Hb) stability than short-acting ESAs. Objective: We aimed to evaluate the efficacy and safety of intravenous CKD-11101 (a biosimilar of darbepoetin-alfa) compared with those of darbepoetin-alfa in hemodialysis patients. Methods: The study was performed in 24 centers in Korea between June 2015 and June 2017. The study subjects were randomized in a double-blind manner. The follow-up duration was 24 weeks, which consisted of 20 weeks of maintenance and 4 weeks of evaluation period. All patients underwent a stabilization period to achieve a target baseline Hb of 10–12 g/dL before randomization. Following randomization, patients received darbepoetin-alfa or CKD-11101 weekly or biweekly. Results: A total of 403 patients were randomized into two groups, and a total of 325 patients (80.6%) completed the investigation. The differences between the two groups in terms of change in the average Hb level from baseline to evaluation were not significant. The average administered dose of ESA was similar between the groups. There was no difference in the proportion of patients who maintained the target Hb during the evaluation period [60.4% vs. 66.2% in the CKD-11101 and darbepoetin-alfa groups, respectively (p = 0.3038)]. In addition, the safety analysis, consisting of adverse events and adverse drug reactions, showed comparable results between the two groups. Conclusion: The changes in the level of Hb, dose of erythropoietin, and achievement rate of the target Hb during the study period were comparable between the groups. CKD-11101 has an equivalent efficacy and safety compared with darbepoetin-alfa in patients undergoing hemodialysis.

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