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Abstract
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.
Transparency
Declaration of funding
The trial was funded by Chong Kun Dang pharm. Chong Kun Dang pharm developed the protocol, provided clinical research results and analyzed the data.
Declaration of financial/other interests
The authors disclosed that they have no significant relationships with or financial interests in related to this study or article. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Acknowledgements
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.