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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

a Division of Nephrology, Department of Internal Medicine , Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea , Seoul , Korea. b Division of Nephrology, Department of Internal Medicine , Seoul National University College of Medicine , Seoul , Korea. c Division of Nephrology, Department of Internal Medicine , National Health Insurance Corporation IIsan Hospital , Goyang , Korea. d Division of Nephrology, Department of Internal Medicine , Kyungpook National University School of Medicine , Daegu , Korea. e Division of Nephrology, Department of Internal Medicine , Seoul National University Bundang Hospital , Seongnam , Gyeonggi Do , Korea. f Division of Nephrology, Department of Internal Medicine , Yeungnam University School of Medicine , Daegu , Korea. g Division of Nephrology, Department of Internal Medicine , Asan Medical Center, University of Ulsan College of Medicine , Seoul , Korea. h Division of Nephrology, Department of Internal Medicine , College of Medicine, Chosun University , Gwangju , Korea. i Division of Nephrology, Department of Internal Medicine , Ulsan University Hospital , Ulsan , Korea. j Division of Nephrology, Department of Internal Medicine , Inje University, Haeundae Paik Hospital , Busan , Korea. k Division of Nephrology, Department of Internal Medicine , Chonnam National University Medical School , Gwangju , Korea. l Division of Nephrology, Department of Internal Medicine , Chungnam National University Hospital , Daejeon , South Korea. m Division of Nephrology, Department of Internal Medicine , Catholic University of Daegu School of Medicine , Daegu , Korea. n Division of Nephrology, Department of Internal Medicine , College of Medicine, Dong-A University , Busan , Korea. o Division of Nephrology, Department of Nephrology , Ajou University School of Medicine , Suwon , Korea. p Division of Nephrology, Department of Internal Medicine , Keimyung University School of Medicine , Daegu , Korea.

Current medical research and opinion. 2018;:1-17.
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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(R) 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.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine