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논문분류	춘계학술대회 초록집
제목	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
저자	Eun Jeong Ko1, Byung Ha Chung1, Seok Joon Shin2, Hyeong Cheon Park3, Su Hyun Kim4, Chul woo Yang1
출판정보	2018; 2018(1):
키워드	Anemia \| hybrid Fc \| erythropoietin \| dialysis
초록	Objectives: 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 biweekly. 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. Conclusions: 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. Figure 1. Mean hemoglobin change after 12 weeks after administration of GX-E2 or Mircera
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