Abstract: SA-PO802

GX-E2 versus CERA for Anemia in Patients Receiving Maintenance Peritoneal Dialysis: A Phase 2, Randomized, Multi-Center, Active-Comparator, Dose-Finding Safety and Efficacy Study

Session Information

Category: Dialysis

  • 605 Dialysis: Anemia and Iron Metabolism

Authors

  • Ko, Eun jeong, Seoul St. Mary's Hospital, Seoul, Korea (the Republic of)
  • Song, Ho Cheol, Incheon St. Mary's Hospital, Gyeonggi, Korea (the Republic of)
  • Kim, Su Hyun, Chung-Ang University Hospital, Seoul, Korea (the Republic of)
  • Na, Ki Young, Seoul National University Bundang Hospital, Gyeonggi, Korea (the Republic of)
  • Jo, Young-Il, Konkuk University Hospital, Seoul, Korea (the Republic of)
  • Kim, Won, Chobuk National Univeristy Medical School, Jeonju, Korea (the Republic of)
  • Seong, Eun Young, Pusan National University Hospital, Busan, Korea (the Republic of)
  • Kim, Yong-Lim, Kyungpook National University Hospital, Daegu, Korea (the Republic of)
  • Heo, Minkyu, Genexine, Inc., Seongnam-si, Korea (the Republic of)
  • Woo, Jungwon, Genexine, Inc., Seongnam-si, Korea (the Republic of)
  • Yang, Chul Woo, Seoul St. Mary's Hospital, Seoul, Korea (the Republic of)
  • Chung, Byung ha, Seoul St. Mary's Hospital, Seoul, Korea (the Republic of)
  • Shin, Sug kyun, Ilsan Hospital NHIS, Gyeonggi, Korea (the Republic of)
  • Kim, Hyung Wook, St. Vincent's Hospital, Gyeonggi, Korea (the Republic of)
  • Shin, Byung chul, Chosun University, Gwangju, Korea (the Republic of)
  • Shin, Seok Joon, Incheon St. Mary's Hospital, Gyeonggi, Korea (the Republic of)
  • Park, Hyeong cheon, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea (the Republic of)
  • Kang, Young Sun, Korea University Medical College Ansan Hospital, Gyeonggi, Korea (the Republic of)
  • Lee, Sang-Ho, Kyung Hee University Hospital, Seoul, Korea (the Republic of)
Background

GX-E2 is hybrid Fc (hyFc)-fused long-acting recombinant human erythropoietin. We conducted a phase 2, randomized, active-comparator, safety and efficacy study in patients with anemia receiving maintenance peritoneal dialysis.

Methods

Patients with a stable end-stage renal disease treated with peritoneal dialysis were included. In Part A, a dose-finding study was conducted in 60 subjects with 4-week treatment of six different dosage of GX-E2. In Part B, 12-week treatment was conducted in 72 individuals with two selected doses of GX-E2 based on the Part A results, and with methoxy polyethylene glycol-epoetin β (CERA) (0.6 μg/kg bi-weekly). Primary endpoint was mean hemoglobin change from baseline to the end of treatment.

Results

In Part A, mean Hb level was significantly increased after 4 weeks GX-E2 administration and mean Hb changes from baseline were 0.6±1.3 g/dL in 3 μg/kg, 1.3±1.1 g/dL in 5 μg/kg, and 1.4±1.0 g/dL in 8 μg/kg bi-weekly. In Part B, participants were randomly assigned to 3 groups, treated bi-weekly with 5 μg/kg, 8 μg/kg of GX-E2 and 0.6 μg/kg of CERA. Mean Hb level changes after 12 weeks GX-E2 administration were 2.2±1.3 g/dL in 5 μg/kg, 3.1±1.1 g/dL in 8 μg/kg, and 1.7±1.4 g/dL in CERA, GX-E2 showed comparable or better outcome compared to CERA (p-values for each 0.233, <0.001). No safety issues were observed.

Conclusion

In this phase 2 study of anemia treatment in patients with end-stage renal disease on maintenance peritoneal dialysis, GX-E2 was well-tolerated and effectively maintained Hb levels.(grant number: HI14C1038)

Funding

  • Commercial Support