NCT01846689Unknown3 期
An Open-label Trial of an Erythropoietin Stimulating System to Determine Increased Red Blood Cell Production in Subjects Diagnosed With Anemia of Chronic Disease
Targeted Medical Pharma1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Hemoglogin/Hematocrit
研究概览
简要总结
The objective of this study is to measure the change in blood values after the administration of an amino acid based erythropoietin stimulating system.
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
- •M/F patients 18 years old and over, non-pregnant/lactating
- •Hemoglobin < 10 female,<11 male
- •Ferritin > upper limit of normal for lab indicative of chronic anemia
- •Anemia of chronic disease
- •Crt. < 3.0
排除标准
- •Currently taking other amino acid formulations.
- •Pregnant or unwilling to use adequate birth control for the duration of the study.
- •Excessive alcohol or illicit drug use.
- •Unwilling or unable to sign informed consent.
- •Myocardial infarction within the last 6 months.
- •Patients ever having taken or currently taking an erythropoietin medication.
- •Iron deficiency (add criteria).
- •On dialysis.
- •Malignancy other than non-melanoma skin cancer within the last 5 years. If has such malignancy, must have documentation of no recurrence for at least 5 years.
- •Liver cirrhosis (add criteria).
研究组 & 干预措施
ESS
Experimental
Prescription medical food erythropoietin stimulating system
干预措施: ESS (medical food/drug) (Drug)
结局指标
主要结局
Hemoglogin/Hematocrit
时间窗: 28 Days
次要结局
- Red blood cell count(28 Days)
- Reticulocyte count(28 days)
- IGF-1(28 days)
研究者
研究点 (1)
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