Comparison of Acetoacetate and Acetate Kidney Uptake in Patients With Chronic Kidney Failure Measured by Positron Emission Tomography : the RENO-TEP Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Mean in kidney acetate metabolism
研究概览
简要总结
The objective of this study is to nake a comparison between 11c-acetate and 11c-acetoacetate kidney uptake in chronic kidney failure patients.
详细描述
Chronic kidney failure patients will be ask to perform two positron emission tomography scan during the same day. One, with a 11C-Acetate Tracer and the other with 11C-Acetoacetate. The results will allow to determine the difference between the two tracers and will ultimately be compared with precedent results of healthy controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •BMI between 18.5 and 40
- •Kidney failure if GFR betweem 30 and 60 mL/min/1.73m2
- •Stable medication for at least 4 weeks
排除标准
- •Receive cytotoxic therapy for primary or secondary kidney disease within 6 months prior to enrollment
- •Organ Transplant History
- •Class IV congestive heart failure (New York Heart Association)
- •Myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrollment
- •Coronary revascularization (percutaneous coronary intervention or arterial bypass) or valve repair/replacement within 12 weeks of enrollment or is scheduled to undergo one of these procedures within 4 weeks of enrollment
- •Any condition outside the realm of renal and cardiovascular disease, such as, but not limited to, malignancy, with a life expectancy of less than 2 years in the clinical judgment of the investigator
- •Active malignancy requiring treatment at Visit 1 (except successfully treated basal or squamous cell carcinoma).
- •Hepatic impairment (aspartate transaminase or alanine transaminase >3x upper limit of normal; or total bilirubin >2x upper limit of normal at time of enrollment
- •Pregnancy or lactation
- •Adherence to a ketogenic diet, consumption of ketogenic products or supplements or intermittent fasting or other diet or supplements that may significantly increase ketones in the past two months.
- •Daily alcohol consumption >2 servings per day
- •Participation in other interventional research projects concurrently or participation in other PET research projects in the last year, which exceeds the recommended limits
- •Inability to lie still in supine position;
- •Medical fluid restriction limiting fluid intake for the procedure
结局指标
主要结局
Mean in kidney acetate metabolism
时间窗: 30 minutes
Kidney acetate metabolism measured by pet scan
Mean in kidney acetoacetate uptake
时间窗: 30 minutes
Kidney acetoacetate uptake measured by pet scan
Mean in kidney acetate uptake
时间窗: 30 minutes
Kidney acetate uptake measured by pet scan
Mean in kidney acetoacetate metabolism
时间窗: 30 minutes
Kidney acetoacetate metabolism measured by pet scan
次要结局
- Mean in heart ejection fraction(30 minutes)