Comparing kidney uptake of two tracers in chronic kidney failure patients

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

This study is testing how well two different tracers are taken up by the kidneys in people with chronic kidney failure to learn more about their kidney function.

Quick facts

• Study type: Observational
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Université de Sherbrooke (Academic / other)
• Locations: 1 site (Sherbrooke, Quebec)
• Trial ID: NCT05968391 on ClinicalTrials.gov

What this trial studies

This observational study aims to compare the kidney uptake of two different tracers, 11C-Acetate and 11C-Acetoacetate, in patients with chronic kidney failure. Participants will undergo two positron emission tomography (PET) scans on the same day, one for each tracer. The results will be analyzed to determine the differences in uptake between the two tracers and will be compared to previous results from healthy controls. This approach may provide insights into metabolic processes in chronic kidney failure.

Who should consider this trial

Good fit: Ideal candidates are adults with chronic kidney failure and a GFR between 30 and 60 mL/min/1.73m2.

Not a fit: Patients with recent history of significant cardiovascular events or those with active malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of kidney metabolism in chronic kidney failure, potentially leading to improved diagnostic methods.

How similar studies have performed: While similar studies have explored metabolic imaging in kidney disease, this specific comparison of tracers is novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Sherbrooke, Quebec

• Centre de recherche sur le vieillissement — Sherbrooke, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Mélanie Godin, MD — Université de Sherbrooke
• Study coordinator: Valerie St-Pierre, MSc

Conditions Kidney Failure, Chronic; ketone; acetoacetate; acetate