NCT04051957终止2 期
Isosorbide Mononitrate For Anti-Vascular Endothelial Growth Factor (VEGF) Induced Kidney Injury
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of Participants With a Reduction in UPC of > 500 mg/Day From That Measured Before Enrollment
研究概览
简要总结
The purpose of this study is to test the hypothesis that isosorbide mononitrate prevents deterioration of renal function in patients receiving anti-angiogenic therapies that target vascular endothelial growth factor (VEGF).
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 blinded
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients on or enrolled for anti-VEGF therapy
- •new-onset proteinuria, defined as a urine protein: creatinine ratio (UPC) of >500mg/g or hypertension (Systolic BP ≥ 140 mm Hg and/or diastolic BP ≥ 90 mm Hg) or a decrease in eGFR by ≥ 25% from baseline before starting therapy.
排除标准
- •Pregnant women
- •Breast-feeding women.
研究组 & 干预措施
Isosorbide Mononitrate
Experimental
干预措施: Isosorbide Mononitrate (Drug)
Placebo
Placebo Comparator
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Number of Participants With a Reduction in UPC of > 500 mg/Day From That Measured Before Enrollment
时间窗: Baseline, Month 3
Number of Participants With a Reduction in Urine Protein Creatinine Ratio (UPC) of > 500 mg/Day From That Measured Before Enrollment
时间窗: Baseline, Month 1
次要结局
- Number of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) ≥25% From Before Enrollment(Baseline, Month 3)
- Number of Participants With Reduction in Systolic Blood Pressure (SBP) of ≥ 10 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 5 mm Hg From Before Enrollment(Baseline, Week 12)
研究者
Jaya Kala
Assistant Professor
The University of Texas Health Science Center, Houston
研究点 (1)
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