跳至主要内容
临床试验/NCT00293202
NCT00293202终止2 期

The Effect of Etanercept in Suppression of the Systemic Inflammatory Response in Hemodialysis Patients

Kaysen, George A., M.D., Ph.D.1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2005年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
发起方
入组人数
10
试验地点
1
主要终点
C-reactive Protein

研究概览

简要总结

Etanercept is a novel anti-inflammatory agent currently used in patients with rheumatoid arthritis. We are examining whether Etanercept is effective in improving the nutritional status of hemodialysis patients as a consequence of its ability to decrease inflammation.

详细描述

Hemodialysis patients with end stage renal disease have a high mortality rate. In individual patients, mortality is associated with a low serum albumin concentration, a marker of poor nutritional status, and with elevated C-reactive protein, a marker of inflammation. Since efforts to improve nutrition through dietary intake have not been successful, inflammation is thought to play a key role in determining nutritional status. Recently, it has been shown that malnutrition, inflammation, and atherosclerosis are closely related in patients with chronic renal failure. It is our hypothesis that suppression of the cycle of inflammation, malnutrition, and vascular injury caused by atherosclerosis will improve survival in dialysis patients. This study is designed to examine whether suppression of the inflammatory response can be accomplished safely with Etanercept and to determine if this suppression will improve nutritional status and clinical outcome in hemodialysis patients with poor nutritional status and evidence of inflammation.

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
Triple (Participant, Care Provider, Investigator)

盲法说明

Double Blind Study

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of end stage renal disease

排除标准

  • History of Tuberculosis History of Recurrent Infection Recent AMI, Cancer within previous 5 years Presence of Hepatitis B, Hepatitis C, HIV, systemic lupus erythematosis, presence of transcutaneous access (external catheter)

研究组 & 干预措施

Etanercept 25 mg

Active Comparator

Etanercept 25 mg injection twice a week

干预措施: Etanercept (Drug)

Saline

Placebo Comparator

Saline injection twice a week

干预措施: Placebo (Drug)

结局指标

主要结局

C-reactive Protein

时间窗: 52 weeks

A reduced C-reactive protein (CRP) concentration is expected.

Albumin

时间窗: 52 weeks

An increased serum albumin (ALB) concentration expected. Higher concentrations of Albumin indicate better outcome. Normal ranges of Albumin in this study is from 3.5 to 5.5 gram per deciliter (g/dL). We expect ALB to remain or increase in this study.

次要结局

  • Prealbumin (mg/dL)(52 weeks)

研究者

发起方
Kaysen, George A., M.D., Ph.D.
申办方类型
Other
责任方
Principal Investigator
主要研究者

George A. Kaysen, M.D., Ph.D.

Professor

Kaysen, George A., M.D., Ph.D.

研究点 (1)

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