ASN's Mission

ASN leads the fight to prevent, treat, and cure kidney diseases throughout the world by educating health professionals and scientists, advancing research and innovation, communicating new knowledge, and advocating for the highest quality care for patients.

learn more

Contact ASN

1401 H St, NW, Ste 900, Washington, DC 20005

email@asn-online.org

202-640-4660

The Latest on Twitter

Kidney Week

Abstract: SA-PO1018

Efficacy and Safety of CKD-11101 (Darbepoetin-Alfa Proposed Biosimilar) Compared with Darbepoetin Alfa in Patient on Hemodialysis

Session Information

Category: Dialysis

  • 701 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Kim, Yaerim, Seoul National University Hospital, Seoul, Korea (the Republic of)
  • Kim, Yong-Lim, Kyungpook National University Hospital, Daegu, Korea (the Republic of)
  • Kim, Soo Wan, Chonnam National University Medical School , Gwangju, Korea (the Republic of)
  • Kang, Duk-Hee, Ewha University College of Medicine, Seoul, Korea (the Republic of)
  • Lee, Kang Wook, Chungnam National University Hospital, Daejeon, Korea (the Republic of)
  • An, Won Suk, Dong-A University, Busan, Korea (the Republic of)
  • Lee, Jung Pyo, Seoul National University Boramae Medical Center, Seoul, Korea (the Republic of)
  • Joo, Kwon Wook, Seoul National University Hospital, Seoul, Korea (the Republic of)
  • Oh, Dong-jin, Myongji Hospital, Koyang, Korea (the Republic of)
  • Do, Jun-Young, Yeungnam University Hospital, Daegu, Korea (the Republic of)
  • Paek, Jin hyuk, Keimyung University School of Medicine, Daegu, Korea (the Republic of)
  • Park, Woo Yeong, Dongsan Medical Center, Daegu, Korea (the Republic of)
  • Jin, Kyubok, Keimyung University School of Medicine, Daegu, Korea (the Republic of)
  • Park, Su-Kil, Asan Medical Center, Seoul, Korea (the Republic of)
Background

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.

Methods

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.

Results

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.

Conclusion

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.

Funding

  • Commercial Support