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

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Author(s)
Jong Hoon LeeByung Ha ChungKwon Wook JooSug Kyun ShinYong-Lim KimKi Young NaJun-young DoSu-Kil ParkByung Chul ShinJong Soo LeeYang-Wook KimSoo Wan KimKang Wook LeeGun Woo KangWon Suk AnGyu-Tae ShinSeungyeup HanChul Woo Yang
Keimyung Author(s)
Han, Seung Yeup
Department
Dept. of Internal Medicine (내과학)
Journal Title
Current Medical Research and Opinion
Issued Date
2019
Volume
35
Issue
6
Keyword
ErythropoietinDarbepoetinErythropoiesis stimulating agentAnaemiaChronic kidney disease
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 multicentre, 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 four 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 0.01g/dL (95% CI -0.213, 0.242), indicating that CKD-11101 was equivalent to NESP. The difference in mean administration dose between groups was -1.40mcg (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.
Keimyung Author(s)(Kor)
한승엽
Publisher
School of Medicine (의과대학)
Citation
Jong Hoon Lee et al. (2019). Efficacy and safety of CKD-11101 (darbepoetin-alfa proposed biosimilar) compared with NESP in anaemic chronic kidney disease patients not on dialysis. Current Medical Research and Opinion, 35(6), 1111–1118. doi: 10.1080/03007995.2018.1560134
Type
Article
ISSN
1473-4877
Source
https://www.tandfonline.com/doi/full/10.1080/03007995.2018.1560134
DOI
10.1080/03007995.2018.1560134
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/41896
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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