Pilot Study of Epoetin Alfa in Idiopathic Anemia of Aging (IAA)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 试验地点
- 2
- 主要终点
- Response of Anemia
研究概览
简要总结
The purpose of this trial is to examine whether Epoetin Alfa, a hormone stimulating production of red blood cells, can reverse idiopathic anemia.
详细描述
As individuals become older, the frequency of anemia increases. While the cause of anemia in many cases can be determined and corrected, in a number of individuals there is no correctable cause found and the patient must live with their anemia. This is known as idiopathic anemia, and can have serious consequences for the individual. Numerous studies have demonstrated that anemia is associated with loss of energy and stamina, causing individuals to decrease their activities, which adversely affects both their sense of well-being as well as their physical strength. Losses in these areas are associated with the clinical manifestations of frailty.
The current pilot study will examine whether or not administration of Epoetin Alfa, a hormone stimulating production of red blood cells, can reverse this type of anemia. We will examine the consequences of reversing the anemia in terms of physical strength and function, cardiovascular function and sense of well-being and mental function.
In this study, individuals with anemia will be treated for six months with Epoetin Alfa following the correction of their anemia and measurements done to evaluate physical strength, performance, cardiac, mental and kidney function. At the end of treatment, individuals will be followed for an additional six months to determine whether the anemia recurs and physical function decreases.
Participation in this study is voluntary. All testing and medication received are free to the participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 70 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •70 years of age or older
- •Diagnosed with anemia
- •Hemoglobin level less than or equal to 11
- •Able to perform most activities of daily living without restriction
排除标准
- •History of serious heart, liver or kidney disease
- •Cancer treated within the last year except for skin cancer (excluding melanoma)
- •Problems with your immune system
- •Received Epoetin Alfa within the last year
结局指标
主要结局
Response of Anemia
次要结局
- To determine if there is a beneficial effect of quality of life, cognitive function, and physical function.
