Kidney Failure, ChronicRENO-TEPNCT05968391
Acetoacetate and Acetate Metabolism in Patients With Chronic Kidney Failure.(RENO-TEP)
An observational study of Kidney Failure, Chronic, run by Université de Sherbrooke at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- PET scan metabolic day
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 2 Feb 2024to 15 Feb 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with kidney failure
Who may be able to join
- 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
Who cannot join
- Receive cytotoxic therapy for primary or secondary kidney disease within 6 months prior to enrollment
- Organ Transplant History
- Class IV congestive heart failure (New York Heart Association)
- Myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrollment
- 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
- 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
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- Active malignancy requiring treatment at Visit 1 (except successfully treated basal or squamous cell carcinoma).
- Hepatic impairment (aspartate transaminase or alanine transaminase >3x upper limit of normal; or total bilirubin >2x upper limit of normal at time of enrollment
- Pregnancy or lactation
- 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.
- Daily alcohol consumption >2 servings per day
- Participation in other interventional research projects concurrently or participation in other PET research projects in the last year, which exceeds the recommended limits
- Inability to lie still in supine position;
- Medical fluid restriction limiting fluid intake for the procedure
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de recherche sur le vieillissement
Sherbrooke, Quebec, J1H 4C4
About this study
Official title: 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.
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.
- Conditions
- Kidney Failure, Chronic
- Being tested
- PET scan metabolic day
- Keywords
- ketone, acetoacetate, acetate
- Medical subject headings
- Kidney Failure, Chronic, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET scan metabolic dayRadiation
11C-Acetate and 11C-Acetoacetate PET scans
| Study group | Role | What they receive |
|---|---|---|
| Chronic kidney failure | No interventions for the purpose of the study. They will simply undergo two PET scans consecutively Receives: Radiation: PET scan metabolic day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean in kidney acetate uptake
Kidney acetate uptake measured by pet scan
Measured: 30 minutes
Mean in kidney acetoacetate uptake
Kidney acetoacetate uptake measured by pet scan
Measured: 30 minutes
Mean in kidney acetoacetate metabolism
Kidney acetoacetate metabolism measured by pet scan
Measured: 30 minutes
Mean in kidney acetate metabolism
Kidney acetate metabolism measured by pet scan
Measured: 30 minutes
Secondary outcomes (1)
Mean in heart ejection fraction
Ejection fraction measured by pet scan
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start2 Feb 2024
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Nestle Health Science
- Responsible party
- Sponsor
- Investigators
- Mélanie Godin, MD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968391
- Sponsor's protocol ID
- 2024-5157
- Acronym
- RENO-TEP
- Status last verified
- Oct 2026
- First submitted
- 20 Jul 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No