Efficacy and safety of CKD-11101 (darbepoetin-alfa proposed biosimilar) compared with NESP in anaemic chronic kidney disease patients not on dialysis

Jong Hoon Lee, Byung Ha Chung, Kwon Wook Joo, Sug Kyun Shin, Yong Lim Kim, Ki Young Na, Jun young Do, Su Kil Park, Byung Chul Shin, Jong Soo Lee, Yang Wook Kim, Soo Wan Kim, Kang Wook Lee, Gun Woo Kang, Won Suk An, Gyu Tae Shin, Seungyeup Han, Chul Woo Yang

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3 Citations (Scopus)


Objective: To evaluate the efficacy and safety of CKD-11101 (biosimilar darbepoetin-alfa, Chong Kun Dang Pharm.) compared with NESP® in treatment of anaemia in patients with chronic kidney disease not on dialysis. Clinical Trial Registration: NCT03431623. Method: In this multi-centre, randomized, double-blind study, patients were treated with CKD-11101 and NESP. The efficacy evaluation period (EEP) was 24 weeks, during which patients were treated every 2 weeks. All patients who completed the EEP were treated with CKD-11101 every 2 weeks for the first 4 weeks and every 4 weeks for the safety evaluation period (SEP), which was from 24 weeks to 52 weeks. The primary efficacy endpoint was the change in mean haemoglobin (Hb) level from baseline to end of EEP and mean dose needed to achieve the target Hb. Results: The mean Hb level was increased in both groups during the EEP (both p < 0.001). The difference in mean Hb level change between the two groups was 0.01 g/dL (95% CI = –0.213–0.242), indicating that CKD-11101 was equivalent to NESP. The difference in mean administration dose between groups was –1.40 mcg (95% CI = –6.859–4.059) included in the equivalent range. The incidence of AEs and ADRs was not different between the two groups, and the frequency of ADRs was favourable in both groups (1.2% in CKD-11101 vs 7.7% in the NESP to CKD-11101 conversion group). Conclusion: CKD-11101 has an equivalent therapeutic effect as NESP in chronic kidney disease patients with renal anaemia. CKD-11101 can be safely used for long-term treatment and in patients converted from NESP.

Original languageEnglish
Pages (from-to)1111-1118
Number of pages8
JournalCurrent Medical Research and Opinion
Issue number6
Publication statusPublished - 2019 Jun 3

Bibliographical note

Funding Information:
The trial was funded by Chong Kun Dang pharm. Chong Kun Dang pharm developed the protocol, provided clinical research results and analyzed the data.

Funding Information:
We thank all those involved in this study, including the patients and investigators who participated. Medical writing support (in the form of development of a draft outline in consultation with the authors, assembly of tables and figures, copyediting and fact checking) was provided by Chong Kun Dang Pharm.

Publisher Copyright:
© 2019, © 2019 Informa UK Limited, trading as Taylor & Francis Group.

All Science Journal Classification (ASJC) codes

  • Medicine(all)


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