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

Recruiting

• Conditions: Kidney Failure, Chronic
• Interventions: Radiation: PET scan metabolic day

• Registration Number: NCT05968391
• Lead Sponsor: Université de Sherbrooke

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

Study Timeline

• Study First Submitted: 2023-07-20
• Study First Submitted QC: 2023-07-20
• Study First Posted: 2023-08-01
• Study Start: 2024-02-02
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-06-03
• Primary Completion: 2024-12-15
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic kidney failure	PET scan metabolic day	No interventions for the purpose of the study. They will simply undergo two PET scans consecutively

Primary Outcome Measures

Name	Time	Method
Mean in kidney acetate uptake	30 minutes	Kidney acetate uptake measured by pet scan
Mean in kidney acetoacetate uptake	30 minutes	Kidney acetoacetate uptake measured by pet scan
Mean in kidney acetoacetate metabolism	30 minutes	Kidney acetoacetate metabolism measured by pet scan
Mean in kidney acetate metabolism	30 minutes	Kidney acetate metabolism measured by pet scan

Secondary Outcome Measures

Name	Time	Method
Mean in heart ejection fraction	30 minutes	Ejection fraction measured by pet scan

Trial Locations

Locations (1)

Centre de recherche sur le vieillissement; 🇨🇦 Sherbrooke, Quebec, Canada