study to evaluate the efficacy and safety of gx-e2 in the anemic patients diagnosed with chronic kidney disease (ckd)

Conditions: Anemia; Chronic Kidney Disease

Summary: 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

Eligibility criteria:
inclusion criteria: * written informed consent * ≥18 yr of age * chronic kidney diseases with hemodialysis, peritoneal dialysis with kt/v ≥ 1.2 (hemodialysis) or kt/v ≥ 1.7 (peritoneal dialysis) within a year * adequate transferrin saturation (≥20%), serum ferritin (≥100ug/l) * should have received vitamine b12 ≥ 3 months before the first dose of study agent * should have received folate ≥3 months before the first dose of study agent * no erythropoietin (epo) therapy within 2 months before the planned first dose of gx-e2 and hb\<10g/dl or no epo therapy within a month (peritoneal dialysis) or 2 weeks (hemodialysis) before the planned first dose of gx-e2 and hb\<10g/dl. exclusion criteria: * refractory to erythropoiesis stimulating agent (esa) treatment * history of blood transfusion within 3 months * donation or loss of blood for more than 400 milliliters (ml) within 8 weeks * history of a known or suspected hypersensitivity, shock, or past history to the investigational drug or to similar esa drugs * acute or chronic organ seizure disorder (including asthma and chronic obstructive pulmonary disease) which may be clinically deteriorated by the drug administration * active infection or history of infection that required intravenous injection of antibiotics in the last two months * grand mal epilepsy * major surgery within 3 months other than access surgery * malignant tumor within 5 years other than successfully treated skin cancer that is not melanoma * ischemic stroke within 3 years * chest x-ray findings determined that they cannot participate in the study for clinically abnormal findings by the baseline chest x-ray findings or previously taken chest x-ray findings * uncontrolled hypertension * congestive heart failure more severe than nyha functional class iii; unstable coronary artery disease (cad); myocardial infraction within 3 months * uncontrolled arrhythmia * high risk of thrombosis and embolism * systemic blood diseases (e.g. pure red cell anemia, sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia) * absolute neutrophil count below 1,500 per microliter (ul) within screening periods * platelet count less than 5e10 per liter (l) within screening periods * hyperparathyrodism / hypothyrodism * splenomegaly caused by anemia or severe splenomegaly (\>20cm) * blood aspartate aminotransferase/alanine aminotransferase (alt/ast) concentration exceeds three times upper normal limit of normal (unl) * blood total bilirubin concentration exceeds 1.5 times upper normal limit of normal (unl) * blood albumin concentration below 3g per deciliter (dl) * history of drug or alcohol abuse in the 6 months prior to the screening * history of psychotropic or narcotic analgesic drugs dependence within 6 months prior to the screening * mental disorder or other central nervous system disorder determined that the study evaluation cannot be conducted * lack of understanding of the study and cooperation (one with no intention to give efforts to perform each evaluation visit and extend previously planned elective surgery) * female subjects with childbearing potential who are pregnant, breastfeeding or intends to become pregnant * participation in any drug study within 30 days prior to dosing * any other ineligible condition at the direction of the investigator that would be ineligible to participate the study

Keywords: phase 2