A Prospective, Comparative, Randomized, Multicenter Study of Peg EPO in the Treatment of Anemia due to Chronic Kidney Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 15
- 主要终点
- To compare proportion of patients achieving a pre-specified Hb target
研究概览
简要总结
In chronic kidney disease, as nephrons are progressively lost, the body attempts to maintain homeostasis via multiple adaptive and maladaptive processes, including a complex range of biochemical and physiologic abnormalities.
As anemia is very common in CKD patients, treatment with erythropoiesis stimulating agent (ESAs) is recommended for patients with chronic kidney disease, even those with moderate disease not yet requiring dialysis, need to be periodically monitored for anemia.
Pegylated Recombinant Erythropoietin is a pegylated form of Erythropoietin which can be used IV or subcutaneously for treatment of anemia due to chronic kidney disease at once a twice weekly dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either sex with an age ≥ 18 years 2.Anemia 3.Have not participated in any other investigational drug trial in the last 3 months 4.Have given informed consent to participate in this study.
排除标准
- •1.Patient who have overt gastrointestinal bleeding,or bleeding episode necessitating transfusion within 4 weeks before screening.
- •2.Patient who have any active malignant disease (except non-melanoma skin cancer).
- •3.Patients with known hypersensitivity to mammalian cell-derived products or Albumin (Human) 4.Patients with uncontrolled hypertension.
- •5.Patients scheduled for major elective orthopaedic surgery or renal transplant and not participating in an autologous blood predonation programme, patients with severe coronary, peripheral arterial, carotid or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident or any serious life threatening disease or disorder.
- •6.Any history or presence of clinically significant disease or any other condition which, in the opinion of the Investigator could jeopardize the safety of the subject or the validity of the study results 7.Patient with any specific disease who are not eligible for the use of erythropoiesis stimulating agent (ESA).
- •8.Hypersensitivity to the active substance or to any of the excipients 9.Patients who for any reason cannot receive adequate antithrombotic prophylaxis 10.Pregnant and / or Breast feeding Female Patient.
结局指标
主要结局
To compare proportion of patients achieving a pre-specified Hb target
时间窗: End of study
次要结局
- To compare mean dose of Intas Peg EPO with MIRCERA® required to achieve target Hb(84 Days)
- To observe & compare Incidence of drug related Adverse Events as assessed by clinical examination, vitals and / or laboratory parameters(84 Days)