NCT02366325Unknown2 期
A Phase 2, Open-Label, Multi-Center , Dose-Finding Study of the Safety and Efficacy of Pegol-Sihematide (EPO-018B) for the Treatment of Anemia in Patients With End-Stage Renal Disease Receiving Maintenance Hemodialysis (HD)
Jiangsu Hansoh Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of participants who achieved a target hemoglobin response during the study
研究概览
简要总结
The purpose of this study is to evaluate the safety,efficacy, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple intravenous doses of EPO-018B in participants with chronic kidney disease (CKD) who are on hemodialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females>=18 and≤
- •Receiving dialysis for at least 2 weeks before the first study dose.
- •Patients who have not received any erythropoietic agents within 6 weeks prior to the first study dose.
- •Two hemoglobin values of ≥ 6.0 and < 10.0 g/dL at Screening
- •Patients with a transferrin saturation ≥ 20% or a ferritin≥ 100 ng/mL. vitamin B12 and folic acid level above lower limit of normal.
- •Signed informed consent.
排除标准
- •Pregnant or lactating females.
- •Red blood cell transfusion within 3 months prior to study drug administration.
- •Known intolerance to any erythropoiesis stimulating agent (ESA) or pegylated molecule or to all parenteral iron supplementation products.
- •Hemolytic syndromes or coagulation disorder.
- •Hematological disease (including but not limited to myelodysplastic syndrome, hematological malignancy, , hemoglobinopathy, pure red cell aplasia).
- •Chronic, uncontrolled, or symptomatic inflammatory disease (e.g., rheumatoid arthritis,systemic lupus erythematosus, etc.).
- •C reactive Protein (CRP) level greater than 30 mg/L within the 4 weeks prior to study drug administration.
- •Uncontrolled or symptomatic secondary hyperparathyroidism，iPTH>500pg/ml.
- •Poorly controlled hypertension within 2 weeks prior to study drug administration, per investigator's clinical judgment (e.g. systolic ≥ 160mm Hg, diastolic ≥ 100 mm Hg).
- •Chronic congestive heart failure (New York Heart Association Class IV).
- •Significant symptom within 6 months prior to study drug administration (e.g. myocardial infarction, serious or precarious coronary artery disease,stroke, respiratory disease, autoimmune disease, neuropathy, phrenopathy, hepatopathy including Active hepatitis B, Active hepatitis C, or ALT> 2 x upper limit of normal (ULN), AsT> 2 x upper limit of normal (ULN) , etc.).
- •A positive test for HIV antibody.
- •Tumor malignancy
- •Expected survival less than 12 months,
- •A scheduled kidney transplant
- •Major surgery (may Massive bleeding) during the study
- •Expected conception within 4 Weeks after the end of the Study Treatment
- •The subject has participated in other clinical trial within the 6 weeks prior to study drug administration
- •Have any other condition or prior therapy that, in the investigator's opinion, would make the subject unsuitable for the study, or unable or unwilling to comply with the study procedures.
研究组 & 干预措施
EPO-018B 0.025 mg/kg
Experimental
EPO-018B starting dose of 0.025 milligram per kilogram (mg/kg) administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 6 doses
干预措施: EPO-018B (Drug)
EPO-018B 0.05 mg/kg
Experimental
EPO-018B starting dose of 0.05 milligram per kilogram (mg/kg) administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 6 doses
干预措施: EPO-018B (Drug)
EPO-018B 0.08 mg/kg
Experimental
EPO-018B starting dose of 0.08 milligram per kilogram (mg/kg) administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 6 doses
干预措施: EPO-018B (Drug)
结局指标
主要结局
Percentage of participants who achieved a target hemoglobin response during the study
时间窗: Baseline to Week 24
A target hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 gram per deciliter (g/dL) from baseline and a hemoglobin value ≥ 10.0 g/dL during the study
次要结局
- Incidence of adverse events and serious adverse events(Baseline to Week 24)
- Average reticulocytes and hemoglobin change from baseline(Baseline to Week 24)
- Percentage of participants who response to study drug.(Baseline to Week 24)
研究者
研究点 (1)
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