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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-02

Study Completion Date

2025-06-15

Brief Summary

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

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Detailed Description

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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

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Kidney Failure, Chronic

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic kidney failure

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

PET scan metabolic day

Intervention Type RADIATION

11C-Acetate and 11C-Acetoacetate PET scans

Interventions

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PET scan metabolic day

11C-Acetate and 11C-Acetoacetate PET scans

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No