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

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

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

Study Overview

• Status: Recruiting
• Conditions: Kidney Failure, Chronic
• Intervention / Treatment: Radiation: PET scan metabolic day

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 Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

• Study Contact: Name: Valerie St-Pierre, MSc; Phone Number: 45286 8197802220; Email: valerie.R.st-pierre@usherbrooke.ca

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 4C4
      • Recruiting
      • Centre de Recherche sur le Vieillissement
      • Contact: Valerie St-Pierre, M.Sc; Phone Number: 45286 819-780-2220; Email: valerie.R.st-pierre@usherbrooke.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

People with kidney failure

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic kidney failure; No interventions for the purpose of the study. They will simply undergo two PET scans consecutively	Radiation: PET scan metabolic day; 11C-Acetate and 11C-Acetoacetate PET scans

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean in kidney acetate uptake	Kidney acetate uptake measured by pet scan	30 minutes
Mean in kidney acetoacetate uptake	Kidney acetoacetate uptake measured by pet scan	30 minutes
Mean in kidney acetoacetate metabolism	Kidney acetoacetate metabolism measured by pet scan	30 minutes
Mean in kidney acetate metabolism	Kidney acetate metabolism measured by pet scan	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean in heart ejection fraction	Ejection fraction measured by pet scan	30 minutes

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Collaborators: Nestle Health Science
• Investigators: Principal Investigator: Mélanie Godin, MD, Université de Sherbrooke

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2024
• Primary Completion (Estimated): December 15, 2024
• Study Completion (Estimated): June 15, 2025

Study Registration Dates

• First Submitted: July 20, 2023
• First Submitted That Met QC Criteria: July 20, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): June 3, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: acetate; ketone; acetoacetate
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: 2024-5157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No