Randomized, Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of HX575 Epoetin Alfa vs. US Licensed Epoetin Alfa (Epogen®/Procrit®) in the Treatment of Anemia Associated With Chronic Kidney Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sandoz
- 入组人数
- 435
- 试验地点
- 49
- 主要终点
- Mean Absolute Change in Hemoglobin Levels Between the Screening/Baseline Period (Week -4 to Day 1) and the Evaluation Period (Week 21-28)
研究概览
简要总结
The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US licensed reference product Epogen®/Procrit® when applied subcutaneously. This study is intended to generate data supporting that the efficacy and safety under treatment with HX575 and Epogen®/Procrit® are comparable.
详细描述
This is a randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of HX575 epoetin alfa vs. US-licensed epoetin alfa (Epogen®/Procrit®) in the treatment of anemia associated with chronic kidney disease (CKD).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients with end stage renal disease (stage CKD 5d), receiving stable subcutaneous maintenance therapy with Epogen® or Procrit® at least once per week
- •Mean hemoglobin level between 9.0 - 11.5 g/dL during the screening period
- •Adequate iron substitution
排除标准
- •Contraindications for Erythropoiesis Stimulating Agent (ESA) therapy
- •History of Pure Red Cell Aplasia (PRCA), or anti-erythropoietin (EPO) antibodies
- •Known Human Immunodeficiency Virus (HIV) or Hepatitis B infection
- •Hepatitis C infection on an active treatment
- •Symptomatic congestive heart failure (New York Heart Association [NYHA] class III and IV)
- •Unstable angina pectoris, or cardiac infarction during the last 6 months prior to randomization
- •Percutaneous coronary intervention, or coronary artery bypass grafting during the last 6 months prior to randomization
- •History of malignancy of any organ system
- •Systemic lupus erythematous
- •Immunocompromized patients
- •Other In-/Exclusion criteria may apply
研究组 & 干预措施
HX575 epoetin alfa
HX575, recombinant human epoetin alfa
干预措施: HX575 epoetin alfa (Drug)
US-licensed epoetin alfa
US-licensed recombinant human epoetin alfa
干预措施: US-licensed epoetin alfa (Drug)
结局指标
主要结局
Mean Absolute Change in Hemoglobin Levels Between the Screening/Baseline Period (Week -4 to Day 1) and the Evaluation Period (Week 21-28)
时间窗: Week -4 to Day1 and Week 21-28
Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .
Change in Mean Hb Level Between Baseline (Week -4 to Day1) and Evaluation Period (Week 21-28)
时间窗: Week -4 to Day1 and Week 21-28
Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .
次要结局
- Mean Weekly Dose During Evaluation Period (Week 21-28)(Week 21-28)
- Incidence of Antibody Formation Against Epoetin(52 weeks)