Anemia Clinical Trial
Official title:
Phase II Clinical Trial to Explore the Optimal Fixed Starting Dose & Dosing Interval and to Evaluate the Safety of GX-E2 in the Anemic Patients Diagnosed With Chronic Kidney Disease and Receiving Hemodialysis (HD) / Peritoneal Dialysis (PD)
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
;
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