Phase III, Multicentre, Double-blind, Randomised, Parallel, Equivalence Clinical Trial to Assess Efficacy, Safety of Megalabs® Recombinant i/v Human Erythropoietin Compared to Epogen® in Anaemia in Patients With Chronic Kidney Disease
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Megalabs
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Change in Mean Hb Level
研究概览
简要总结
Phase III, multicentre, double-blind, randomised, parallel, equivalence clinical trial to determine the efficacy, safety and immunogenicity of Megalabs® recombinant human alfa epoetin for intravenous use, compared to Epogen®, in the treatment of anaemia in participants with chronic renal disease, dependent on haemodialysis
详细描述
Patients with chronic kidney disease undergoing hemodialysis will be administered human recombinant alfa epoetin to revert anemia. Hemoglobin, hematocrit and reticulocyte counts will be assessed. Immunogenicity will be evaluated through bi-weekly Anti Drug Antibody determination. Test drug and comparator drug will be compared to evaluate biosimilarity.
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
- Double (Participant, Care Provider)
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
- •Stage V Chronic kidney disease undergoing hemodialysis
排除标准
- •Lack of consent to participate in the trial, other severe chronic disease, history of pure red cell aplasia, existence of anti erythropoietin antibodies
研究组 & 干预措施
Epoetin alfa Megalabs® injectable in intravenous application.
Epoetin alfa Megalabs, Human recombinant epoetin alfa
干预措施: Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration. (Biological)
Epoetin alfa Epogen® injectable in intravenous application.
USA licenced Epoetin alfa, Epogen®, Human recombinant epoetin alfa
干预措施: Active comparator: European Union licenced epoetin alfa (Biological)
结局指标
主要结局
Change in Mean Hb Level
时间窗: 18 months
Response to epoetin alfa in patients with chronic kidney failure is an increase in hematocrit, hemoglobin and reduced transfusion requirements. Hemoglobin is the primary endpoint of the study.
Mean Absolute Change in Hemoglobin Levels
时间窗: 18 months
Response to epoetin alfa in patients with chronic kidney failure is an increase in hematocrit, hemoglobin and reduced transfusion requirements. Hemoglobin is the primary endpoint of the study .
次要结局
- immunogenicity(18 months)