The primary objective of study is * Part A : To explore the optimal fixed starting dose and dosing interval of GX-E2 * Part B : To evaluate the proof of concept (POC) of GX-E2
The secondary objective of study is to evaluate: * change of red blood cell indices in anemic patients with chronic kidney disease receiving hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously * change of reticulocyte indices in anemic patients with chronic kidney disease receiving hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously * safety of GX-E2 when administering intravenously/subcutaneously * incidence of blood transfusion in anemic patients with chronic kidney disease receiving hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously * Immunogenicity in anemic patients with chronic kidney disease receiving hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
257
Bucheon St. Mary's Hospital
Bucheon-si, South Korea
Bundang Seoul National University College of Medicine
Gumi, South Korea
The Catholic University of Korea Incheon St.Mary's Hospital
Incheon, South Korea
Gangnam severance hospital
Seoul, South Korea
average change of Hemoglobin level
change from baseline in Hemoglobin level
Time frame: 6 weeks (Part A) & 14 weeks (Part B)
change of red blood cell indices
change from baseline in red blood cell indices
Time frame: 6 weeks (Part A) & 14 weeks (Part B)
change of reticulocyte indices
change from baseline in reticulocyte indices
Time frame: 6 weeks (Part A) & 14 weeks (Part B)
incidence, degree, outcome of adverse event
Incidence of adverse events
Time frame: 6 weeks (Part A) & 14 weeks (Part B)
incidence, frequency, amount of blood transfusion
Incidence of adverse events
Time frame: 6 weeks (Part A) & 14 weeks (Part B)
immunogenicity: ratio of neutralizing antibody & binding antibody in subjects
comparison from pre-treatment to post-treatment
Time frame: 6 weeks (Part A) & 14 weeks (Part B)
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Each Group of Hemodialysis (n=30) will be administered NESP 30ug
Each Group of Peritoneal dialysis (n=24) will be administered MIRCERA 0.6ug/kg
Seoul St.Mary's Hospital
Seoul, South Korea