The Role of VEGF-A Signaling in Maintenance of the Glomerular Filtration Barrier and Blood Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- Predictive value of soluble factors in the development of proteinuria or hypertension
研究概览
简要总结
This research study is looking at kidney and blood pressure changes in patients receiving bevacizumab, aflibercept, sunitinib, or cediranib for cancer. Studying samples of blood and urine from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment with an antiangiogenic drug.
详细描述
OBJECTIVES:
I. To study the renal and blood pressure changes in patients treated with bevacizumab, aflibercept, sunitinib malate, or cediranib for their cancer.
II. To determine the physiological mechanisms behind proteinuria and hypertension induced by antiangiogenic therapies (i.e., rarefaction; imbalance in eNOS, prostacyclin [PGI_2], prostaglandin E2 [PGE_2], and thromboxane A2 [TXA2]; renin/aldosterone; or renovascular hypertension).
III. To determine whether soluble factors (like tyrosine kinase 1 [sFlt1], bFGF, and VEGF) and steady state drug concentration are predictive of the development of proteinuria/hypertension.
OUTLINE: This is a multicenter study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- •Planning to start treatment with one of the following antiangiogenic drugs as single agents or in combination with chemotherapy for their cancer:
- •Cediranib (AZD2171 )
- •Bevacizumab (Avastin)
- •Sunitinib (Sutent)
- •Aflibercept (VEGF Trap)
- •Urinalysis negative for protein OR 24-hour urine for protein < 500 mg
- •Prior chemotherapy within the past 12 months allowed
- •More than 12 months since prior antiangiogenic drugs, including monoclonal antibodies that bind to VEGF or tyrosine kinase inhibitors that block VEGFR2
- •At least 6 weeks since prior and no concurrent aldosterone receptor antagonists (e.g., spironolactone [aldactone] or eplerenone)
- •No other concurrent investigational agents
排除标准
- 未提供
结局指标
主要结局
Predictive value of soluble factors in the development of proteinuria or hypertension
时间窗: Up to 8 weeks
Renal and blood pressure changes
时间窗: Up to 8 weeks
Physiological mechanism behind proteinuria and hypertension induced by antiangiogenic therapies
时间窗: Up to 8 weeks
Predictive value of steady state drug concentrations in the development of proteinuria or hypertension
时间窗: Up to 8 weeks
次要结局
未报告次要终点