Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05968391
Acronym
RENO-TEP
Enrollment
15
Registered
2023-08-01
Start date
2024-02-02
Completion date
2025-06-15
Last updated
2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure, Chronic

Keywords

ketone, acetoacetate, acetate

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.

Interventions

RADIATIONPET scan metabolic day

11C-Acetate and 11C-Acetoacetate PET scans

Sponsors

Nestle Health Science
CollaboratorINDUSTRY
Université de Sherbrooke
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean in kidney acetate uptake30 minutesKidney acetate uptake measured by pet scan
Mean in kidney acetoacetate uptake30 minutesKidney acetoacetate uptake measured by pet scan
Mean in kidney acetoacetate metabolism30 minutesKidney acetoacetate metabolism measured by pet scan
Mean in kidney acetate metabolism30 minutesKidney acetate metabolism measured by pet scan

Secondary

MeasureTime frameDescription
Mean in heart ejection fraction30 minutesEjection fraction measured by pet scan

Countries

Canada

Contacts

Primary ContactValerie St-Pierre, MSc
valerie.R.st-pierre@usherbrooke.ca8197802220

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026