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
- Dialysis: Anemia and Iron Metabolism
November 04, 2017 | Location: Hall H, Morial Convention Center
Abstract Time: 10:00 AM - 10:00 AM
Category: Dialysis
- 605 Dialysis: Anemia and Iron Metabolism
Authors
- Ko, Eun jeong, 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)
- 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)
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 –