Status:
RECRUITING
Acetoacetate and Acetate Metabolism in Patients With Chronic Kidney Failure.(RENO-TEP)
Lead Sponsor:
Université de Sherbrooke
Collaborating Sponsors:
Nestle Health Science
Conditions:
Kidney Failure, Chronic
Eligibility:
All Genders
18+ years
Brief Summary
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
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 2 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 15 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05968391
Start Date
February 2 2024
End Date
June 15 2025
Last Update
June 3 2024
Active Locations (1)
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1
Centre de recherche sur le vieillissement
Sherbrooke, Quebec, Canada, J1H 4C4