NCT02044653已完成2 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 257
- 试验地点
- 5
- 主要终点
- average change of Hemoglobin level
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Group E (Part A)
Experimental
GX-E2 : Subcutaneously injection every 4 weeks (Q4W) at dose 5ug/kg
干预措施: GX-E2 (Drug)
Group A (Part A)
Experimental
GX-E2 : Subcutaneously injection every 2 weeks (Q2W) at dose 3ug/kg
干预措施: GX-E2 (Drug)
Group B (Part A)
Experimental
GX-E2 : Subcutaneously injection every 2 weeks (Q2W) at dose 5ug/kg
干预措施: GX-E2 (Drug)
Group C (Part A)
Experimental
GX-E2 : Subcutaneously injection every 2 weeks (Q2W) at dose 8ug/kg
干预措施: GX-E2 (Drug)
Group D (Part A)
Experimental
GX-E2 : Subcutaneously injection every 4 weeks (Q4W) at dose 3ug/kg
干预措施: GX-E2 (Drug)
Group F (Part A)
Experimental
GX-E2 : Subcutaneously injection every 4 weeks (Q4W) at dose 8ug/kg
干预措施: GX-E2 (Drug)
Group G (Part B)
Experimental
GX-E2 : Subcutaneously injection every 2 weeks (Q2W) at dose 5ug/kg
干预措施: GX-E2 (Drug)
Group H (Part B)
Experimental
GX-E2 : Subcutaneously injection every 2 weeks (Q2W) at dose 8ug/kg
干预措施: GX-E2 (Drug)
Group I (Part B)
Active Comparator
MIRCERA : Subcutaneously injection every 2 weeks (Q2W) at dose 0.6ug/kg
干预措施: MIRCERA (Drug)
Group J (Part B)
Experimental
GX-E2 : Intravenously injection every week (Q1W) at dose 5ug/kg
干预措施: GX-E2 (Drug)
Group K (Part B)
Experimental
GX-E2 : Intravenously injection every week (Q1W) at dose 8ug/kg
干预措施: GX-E2 (Drug)
Group L (Part B)
Experimental
GX-E2 : Intravenously injection every 2 weeks (Q2W) at dose 8ug/kg
干预措施: GX-E2 (Drug)
Group M (Part B)
Active Comparator
NESP : Intravenously injection every week (Q1W) at dose 30ug
干预措施: NESP (Drug)
结局指标
主要结局
average change of Hemoglobin level
时间窗: 6 weeks (Part A) & 14 weeks (Part B)
change from baseline in Hemoglobin level
次要结局
- change of reticulocyte indices(6 weeks (Part A) & 14 weeks (Part B))
- incidence, degree, outcome of adverse event(6 weeks (Part A) & 14 weeks (Part B))
- change of red blood cell indices(6 weeks (Part A) & 14 weeks (Part B))
- immunogenicity: ratio of neutralizing antibody & binding antibody in subjects(6 weeks (Part A) & 14 weeks (Part B))
- incidence, frequency, amount of blood transfusion(6 weeks (Part A) & 14 weeks (Part B))
研究者
研究点 (5)
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