NCT01576341已完成3 期
Open Label, Single Arm, Multicenter Study to Evaluate the Safety and Immunogenicity of HX575 Epoetin Alfa in the Treatment of Anemia Associated With Chronic Kidney Disease in Pre-dialysis and Dialysis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sandoz
- 入组人数
- 417
- 试验地点
- 1
- 主要终点
- Anti-Erythropoietin (EPO) Antibodies
研究概览
简要总结
The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney disease (CKD)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and female patients w or w/o dialysis treatment
- •Stable i.v. or s.c. maintenance therapy with an EU-approved ESA treatment or ESA naïve.
- •Adequate iron substitution
排除标准
- •History of Pure Red Cell Aplasia (PRCA) or anti-erythropoietin (EPO) antibodies
- •Contraindications for ESA therapy
- •Serum albumin < 3.0 g/dL
- •Immunocompromized patients (immunosuppressive treatment, chemotherapy)
- •Hepatitis C infection on an active treatment or hepatitis B or human immunodeficiency virus (HIV) infection
- •Systemic lupus erythematosus
- •Symptomatic congestive heart failure, Unstable angina pectoris, or myocardial infarction within 6 months
- •History of malignancy of any organ system within the last 5 years
- •History of use of any non-EU approved ESA
研究组 & 干预措施
HX575 epoetin alfa (Sandoz)
Experimental
Single arm
干预措施: HX575 epoetin alfa (Sandoz) (Drug)
结局指标
主要结局
Anti-Erythropoietin (EPO) Antibodies
时间窗: 52 weeks
The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay
次要结局
- Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study)(52 weeks)
研究者
研究点 (1)
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