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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

Authors
Kim, YaerimPark, Su-KilCho, Won YongJoo, Kwon WookShin, Sug KyunKim, Dae JoongKim, Yong-LimSon, Sung HyunChung, WookyungLee, Kwang YoungPark, Sung KwangKim, Joong KyungKim, Soo WanKang, Duk-HeeKim, Jin KukJeon, Jin SeokLee, Kang WookLee, Chang HwaOh, Dong-JinAn, Won SukLee, Jong SooKang, Gun WooDo, Jun-youngLee, Jung PyoJin, Kyubok
Issue Date
Feb-2020
Publisher
ADIS INT LTD
Citation
BIODRUGS, v.34, no.1, pp.99 - 110
Indexed
SCIE
SCOPUS
Journal Title
BIODRUGS
Volume
34
Number
1
Start Page
99
End Page
110
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/1042
DOI
10.1007/s40259-019-00396-9
ISSN
1173-8804
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.
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Cho, Won Yong
Anam Hospital (Department of Nephrology and Hypertension, Anam Hospital)
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