Acetoacetate and Acetate Metabolism in Patients With Chronic Kidney Failure.(RENO-TEP)

Study Overview
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Brief Summary
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The objective of this study is to nake a comparison between 11c-acetate and 11c-acetoacetate kidney uptake in chronic kidney failure patients.

Detailed Description
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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.

Official Title
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Comparison of Acetoacetate and Acetate Kidney Uptake in Patients With Chronic Kidney Failure Measured by Positron Emission Tomography : the RENO-TEP Project

Conditions
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Kidney Failure, Chronic

Intervention / Treatment
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* Radiation: PET scan metabolic day


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic kidney failure<br>No interventions for the purpose of the study. They will simply undergo two PET scans consecutively | Radiation: PET scan metabolic day<br>* 11C-Acetate and 11C-Acetoacetate PET scans<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean in kidney acetate uptake | Kidney acetate uptake measured by pet scan | 30 minutes | 
| Mean in kidney acetoacetate uptake | Kidney acetoacetate uptake measured by pet scan | 30 minutes | 
| Mean in kidney acetoacetate metabolism | Kidney acetoacetate metabolism measured by pet scan | 30 minutes | 
| Mean in kidney acetate metabolism | Kidney acetate metabolism measured by pet scan | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean in heart ejection fraction | Ejection fraction measured by pet scan | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ketone, acetoacetate, acetate