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临床试验/NCT00849394
NCT00849394已完成不适用

An Evaluation of Proteinuria in Patients Receiving Shortened Infusions of Bevacizumab

North Texas Veterans Healthcare System3 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2007年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
106
试验地点
3
主要终点
To evaluate the effect of shortened infusions (0.5 mg/kg/min) of bevacizumab on the incidence of proteinuria.

研究概览

简要总结

This is a clinical research study to look at the incidence of proteinuria (a condition in which urine contains an abnormal amount of protein) caused by shortened infusions (given into the vein over 10 or 15 minutes) of bevacizumab (a medication prescribed for colon, lung, or breast cancer). There are currently no published studies or clinical data looking at how safe shortened infusions of bevacizumab are in relationship to the side effect of proteinuria. We hypothesis that shortened infusions of bevacizumab will result in an increased risk for proteinuria compared to the standard infusions of this agent.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Patients must be 18 years older
  • Patients must be receiving his/her first dose of bevacizumab
  • Patients must sign an informed consent

排除标准

  • Patients receiving > 10 mg/kg doses of bevacizumab

结局指标

主要结局

To evaluate the effect of shortened infusions (0.5 mg/kg/min) of bevacizumab on the incidence of proteinuria.

时间窗: 3-6 months

次要结局

  • To evaluate the time (number of days) to the incidence of proteinuria with shortened infusions of bevacizumab AND to evaluate the effect of controlled versus uncontrolled hypertension and the incidence of proteinuria.(3-6 months)

研究者

发起方
North Texas Veterans Healthcare System
申办方类型
Fed

研究点 (3)

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