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

ASJC Scopus subject areas

  • Biotechnology
  • Pharmacology
  • Pharmacology (medical)

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    Kim, Y., Park, S. K., Cho, W. Y., Joo, K. W., Shin, S. K., Kim, D. J., Kim, Y. L., Son, S. H., Chung, W., Lee, K. Y., Park, S. K., Kim, J. K., Kim, S. W., Kang, D. H., Kim, J. K., Jeon, J. S., Lee, K. W., Lee, C. H., Oh, D. J., ... 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, 34(1), 99-110. https://doi.org/10.1007/s40259-019-00396-9