L-Arginine For Anti-VEGF Induced Kidney Injury
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Reduction in proteinuria as measured by protein-creatinine ratio (UPC) > 500 mg/day
研究概览
简要总结
This phase II trial studies how well arginine works in treating patients with kidney injury caused by anti-VEGF drugs used in standard treatment for cancer. Arginine is a nutritional supplement that may control side effects of anti-cancer drugs such as high blood pressure and protein in the urine and may also help to improve kidney function in patients.
详细描述
PRIMARY OBJECTIVES:
I. To assess the value and/or limitations of using orally supplemented arginine (L-arginine) to improve renal function associated with the use of anti-angiogenic therapies that target vascular endothelial growth factor (VEGF).
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive arginine orally (PO) four times daily (QID). Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity.
GROUP II: Patience receive placebo PO QID. Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity.
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
- Single (Participant)
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
- •On or enrolled for anti-VEGF therapy
- •Systolic Blood Pressure >= 140 mm Hg
- •Diastolic Blood Pressure >= 90 mm Hg
- •Proteinuria >= 500 mg/day or worsening glomerular filtration rate (GFR) (> 0.3 mg/dl in 48 hours [hrs.] or > 50% decline from baseline creatinine in 1 week)
排除标准
- •Allergy to L-arginine
- •Systolic Blood Pressure < 140 mm Hg
- •Diastolic Blood Pressure < 90 mm Hg
- •Proteinuria < 500 mg/day
- •Continuous tube feeds (since the medication will be given in-between meals)
研究组 & 干预措施
Group I (arginine)
Patients receive arginine PO QID. Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity.
干预措施: Arginine (Dietary Supplement)
Group II (placebo)
Patience receive placebo PO QID. Treatment continues for up to 3 months in the absence of disease progression or unacceptable toxicity.
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction in proteinuria as measured by protein-creatinine ratio (UPC) > 500 mg/day
时间窗: Baseline up to 3 months
Linear mixed effects regression will be utilized to analyze the longitudinal change of UPC between treatment and placebo groups.
次要结局
- Improved glomerular filtration rate (GFR) >= 25%(Baseline up to 3 months)
- Reduction in systolic blood pressure (SBP) >= 10 mmHg and/or diastolic blood pressure >= 5 mmHg(Baseline up to 3 months)