대한신장학회

논문분류	춘계학술대회 초록집
제목	Efficacy and safety of CKD-11101 (darbepoetin-alfa proposed biosimilar) compared with Darbepoetin alfa in patient on hemodialysis
저자	Yaerim Kim, Su-Kil Park, Won Yong Cho, Kwon Wook Joo, Suk Kyun Shin, Dae Joong Kim, Yong-Lim Kim, Seung Hyun Shon, Wookyung Chung, Kyubok Jin
출판정보	2019; 2019(1):
키워드	Anemia \| Erythropoietin \| Hemodialysis \| End-stage renal disease
초록	Anemia is critical problem which is caused by deficiency of endogenous erythropoietin (EPO) synthesis in patient on dialysis. Darbepoetin-alfa is a useful EPO with long elimination half-life. Herein, we aim to evaluate the efficacy and safety of intravenous CKD-11101 (biosimilar darbepoetin-alfa) compared with darbepoetin-alfa in patients undergoing hemodialysis. The study group composed with 24 different institutes was divided by randomized, double-blinded, and prospectively. Follow-up duration was 24 weeks which was consisted with 20 weeks of maintenance and 4 weeks of evaluation period. All patients underwent the stabilization period to achieve target baseline hemoglobin (Hb) as 10-12 g/dL before randomization. After randomization, patients received EPO by weekly or biweekly with adjusted dose following the permitted rule of darbepoetin alfa. First, we compared the efficacy of CKD-11101 to darbepoetin-alfa. Secondly, we investigated the safety of CKD-11101. A total of 403 patients were randomized to two different groups during June 2015 and June 2017. Among randomized populations, 78 (19.35%) were dropped-out with major infraction or side effect, 325 (80.65%) patients completed the investigation. The average administered dose of EPO was not different in both groups; 74.90 ± 56.85 mcg and 61.96 ± 43.51 mcg in CKD-11101 and darbepoetin-alfa, respectively. During the study period, the percentage of patients with targeted Hb was 19.44% (28/144), and 20.95% (31/148) with CKD-11101 and darbepoetin-alfa, respectively (p = 0.750). There was no difference in rate of patients need to be changed the dose; 95.83% (138/144) and 93.24% (138/148) with CKD-11101 and darbepoetin-alfa (p = 0.331). There was only one patient who needed to be transfused in each group. The difference in change of the level of Hb, dose of EPO, and achievement rate to target Hb during study period was comparable between two groups. CKD-11101 has an equivalent therapeutic efficacy compared with the darbepoetin-alfa in patient undergoing hemodialysis.
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