Efficacy and Safety of CKD-11101 (Proposed Biosimilar of Darbepoetin-Alfa) Compared with Darbepoetin-Alfa in Patients on Hemodialysis: A Randomized, Double-Blinded, Parallel-Group Phase III Study

Kim, Yaerim; Park, Su Kil; Cho, Won Yong; Joo, Kwon Wook; Shin, Sug Kyun; Kim, Dae Joong; Kim, Yong Lim; Son, Sung Hyun; Chung, Wookyung; Lee, Kwang Young; Park, Sung Kwang; Kim, Joong Kyung; Kim, Soo Wan; Kang, Duk Hee; Kim, Jin Kuk; Jeon, Jin Seok; Lee, Kang Wook; Lee, Chang Hwa; Oh, Dong Jin; An, Won Suk; Lee, Jong Soo; Kang, Gun Woo; Young, Jun; Lee, Jung Pyo; Jin, Kyubok

doi:10.1007/s40259-019-00396-9

Cited by 2 publications

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“…20,21 As expected, based on the results of this study, CKD-11101 showed equivalent efficacy and safety profile compared with reference drug for the treatment of renal anemia in the two randomized double-blind confirmatory clinical trials for CKD patients who are on or not on hemodialysis. 22,23 In the present study, the PK and PD characteristics of darbepoetin alfa were similar to the known PK and PD characteristics of darbepoetin alfa. 16,18 In our study, the mean serum concentration of darbepoetin alfa was eliminated following a multi-exponential decrease pattern (Figure 2) and similar patterns were observed the previous clinical studies.…”

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confidence: 84%

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Comparison of Pharmacokinetic, Pharmacodynamic and Tolerability Profiles of CKD-11101, Darbepoetin Alfa (NESP®) Biosimilar, to Those of NESP® After a Single Subcutaneous or Intravenous Administration to Healthy Subjects

Jeon

Kwon

et al. 2021

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Introduction Darbepoetin alfa (NESP ® and ARANESP ® ) has a sustained erythropoietic activity with a longer half-life than conventional recombinant human erythropoietin. CKD-11101 is under clinical development as a biosimilar of darbepoetin alfa. The purpose of this study was to compare the pharmacokinetic (PK), pharmacodynamic (PD), and tolerability profiles of CKD-11101 with those of reference drug in healthy subjects. Methods This study was performed in two parts for healthy subjects. In each period, CKD-11101 and reference, both at 60 μg, were administered via intravenous (IV) or subcutaneous (SC) route of administration. Results After both IV or SC dose, the geometric mean ratio (GMR) of CKD-11101 to reference drug and its 90% confidence intervals (CIs) for C max , AUC 0–last and AUC 0–∞ were all within 0.8–1.25. No statistically significant differences were noted in the maximum baseline adjusted reticulocyte count or the area under the baseline adjusted reticulocyte count-time between the CKD-11101 and reference drug after IV or SC dose (all p -value>0.05). Both CKD-11101 and reference drug were generally well tolerated. Discussion After a single IV or SC dose, the CKD-11101 was well tolerated and showed comparable PK and PD characteristics with reference drug.

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