• Jong Hoon Lee, Ha Chung Byung B a Division of Nephrology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine , The Catholic University of Korea , Seoul , Ko, 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, and Chul Woo Yang.
• a Division of Nephrology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine , The Catholic University of Korea , Seoul , Korea.
• Curr Med Res Opin. 2019 Jun 1; 35 (6): 1111-1118.

ObjectiveTo 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 RegistrationNCT03431623.MethodIn 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.ResultsThe 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).ConclusionCKD-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.

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