跳至主要内容
临床试验/NCT00954486
NCT00954486撤回不适用

An Open-Label, Single-Arm Pilot Study of the Efficacy of Erythropoietin Alfa in Improving Peak Oxygen Consumption in Elderly Subjects With Unexplained Anemia

Stanford University3 个研究点 分布在 1 个国家开始时间: 2008年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
3
主要终点
Change in hemoglobin (Hb) levels

研究概览

简要总结

The primary objective of this study is to assess the ability of epoetin alfa to raise hemoglobin (Hb) levels in elderly outpatients with unexplained anemia. The secondary objectives of this study are to assess the ability of epoetin alfa to improve physical function; cognitive function; and quality of life, and to assess the safety of epoetin alfa in the study population.

详细描述

Eligible subjects will be recruited out of the companion study "Anemia in the Elderly" (NCT00640172), after active participation in that study is complete. Subjects will have had a full hematologic evaluation, and unexplained anemia will have been previously defined.

Subjects will provide baseline physical function testing, including exercise testing on a treadmill and testing how far patients can walk in 6 minutes (walk test), as well as quality of life; activity level; and mental functioning.

Study visits will be weekly, and the dose level may be adjusted to achieve the target hemoglobin level within 16 weeks. Once at target, the drug will be taken for a total of 12 additional weeks. The maximum time on the study drug could be 28 weeks, and the minimum time be on the 14 weeks.

The walk tests and questionnaires will be repeated when the target hemoglobin level is reached, and when treatment is completed. The tests about quality of life, activity level, and mental functioning will be repeated at the end of treatment. Follow-up visits will be every 4 weeks for 12 weeks to check for side effects.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Epoetin alfa, 10,000 units/week

Experimental

Epoetin alfa is a recombinant erythropoietin.

干预措施: Epoetin alfa (Drug)

结局指标

主要结局

Change in hemoglobin (Hb) levels

时间窗: 14 to 28 weeks

Measured in mg/dL

次要结局

  • Improve quality of life(4 to 30 weeks)
  • Improve cognitive function(16 to 30 weeks)
  • Improve physical function(4 to 30 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stanley L Schrier

Principle Investigator

Stanford University

研究点 (3)

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