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RecruitingNCT05968391RENO-TEPUpdated Jun 3, 2024

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

An observational study in Kidney Failure, Chronic, sponsored by Université de Sherbrooke. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-03.

Sponsored by Université de Sherbrooke · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Feb 2024; still recruiting 2 years 8 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
15
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Kidney Failure, Chronic

Keywords

  • ketone
  • acetoacetate
  • acetate
03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's planned enrollment of 15 is below the median of 149 across 394 observational studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Université de Sherbrooke is the lead sponsor of 289 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

People with kidney failure

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
15 participants (estimated)
Patient registry
No

Groups and cohorts

  • Chronic kidney failure

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

    Radiation: PET scan metabolic day

Interventions

  • RadiationPET scan metabolic day

    11C-Acetate and 11C-Acetoacetate PET scans

06

What researchers measure

Primary outcomes

  1. Mean in kidney acetate uptake

    Kidney acetate uptake measured by pet scan

    Time frame: 30 minutes

  2. Mean in kidney acetoacetate uptake

    Kidney acetoacetate uptake measured by pet scan

    Time frame: 30 minutes

  3. Mean in kidney acetoacetate metabolism

    Kidney acetoacetate metabolism measured by pet scan

    Time frame: 30 minutes

  4. Mean in kidney acetate metabolism

    Kidney acetate metabolism measured by pet scan

    Time frame: 30 minutes

Secondary outcomes

  1. Mean in heart ejection fraction

    Ejection fraction measured by pet scan

    Time frame: 30 minutes

07

Study locations

1 of 1 sites recruiting
  • Centre de recherche sur le vieillissement
    Sherbrooke, Quebec J1H 4C4, Canada
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05968391
Lead sponsor
Université de Sherbrooke
Collaborators
Nestle Health Science
Responsible party
Sponsor
First posted
Aug 1, 2023
Start date
Feb 2, 2024
Primary completion
Dec 15, 2024 (estimated)
Completion
Jun 15, 2025 (estimated)
Last update
Jun 3, 2024

Study contacts

Valerie St-Pierre, MSc
Contact
valerie.R.st-pierre@usherbrooke.ca
8197802220 ext. 45286
Mélanie Godin, MD
principal investigator · Université de Sherbrooke

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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