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

Université de Sherbrooke

Status: Enrolling

Conditions: Kidney Failure, Chronic

Treatments: Radiation: PET scan metabolic day

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05968391

2024-5157

Details and patient eligibility

About

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

Full 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 allow to determine the difference between the two tracers and will ultimately be compared with precedent results of healthy controls.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

1. Receive cytotoxic therapy for primary or secondary kidney disease within 6 months prior to enrollment
2. Organ Transplant History
3. Class IV congestive heart failure (New York Heart Association)
4. Myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrollment
5. 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
6. 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
7. Active malignancy requiring treatment at Visit 1 (except successfully treated basal or squamous cell carcinoma).
8. Hepatic impairment (aspartate transaminase or alanine transaminase >3x upper limit of normal; or total bilirubin >2x upper limit of normal at time of enrollment
9. Pregnancy or lactation
10. 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.
11. Daily alcohol consumption >2 servings per day
12. Participation in other interventional research projects concurrently or participation in other PET research projects in the last year, which exceeds the recommended limits
13. Inability to lie still in supine position;
14. Medical fluid restriction limiting fluid intake for the procedure

Trial design

15 participants in 1 patient group

Chronic kidney failure

Description:

No interventions for the purpose of the study. They will simply undergo two PET scans consecutively

Treatment:

Radiation: PET scan metabolic day