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

Kidney Failure, Chronic Clinical Trial

— RENO-TEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05968391
• Other study ID #: 2024-5157
• Status: Recruiting
• Start date: February 2, 2024
• Est. completion date: June 15, 2025

Study information

• Verified date: May 2024
• Source: Université de Sherbrooke
• Contact: Valerie St-Pierre, MSc
• Phone: 8197802220
• Email: valerie.R.st-pierre[@]usherbrooke.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 15, 2025
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Radiation:
• PET scan metabolic day
11C-Acetate and 11C-Acetoacetate PET scans

Locations

Country	Name	City	State
Canada	Centre de recherche sur le vieillissement	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	Nestle Health Science

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean in kidney acetate uptake	Kidney acetate uptake measured by pet scan	30 minutes
Primary	Mean in kidney acetoacetate uptake	Kidney acetoacetate uptake measured by pet scan	30 minutes
Primary	Mean in kidney acetoacetate metabolism	Kidney acetoacetate metabolism measured by pet scan	30 minutes
Primary	Mean in kidney acetate metabolism	Kidney acetate metabolism measured by pet scan	30 minutes
Secondary	Mean in heart ejection fraction	Ejection fraction measured by pet scan	30 minutes