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Acute Effects of SGLT2 Inhibitor on Kidney Allograft Oxygen Tension: A Randomized, Double-blind, Placebo Controlled Crossover Trial
The goal of this clinical trial is to investigate if a single dose of oral SGLT2i, (50 mg Jardiance) will change oxygen tension in the kidney transplant. The main questions it aims to answer are: * Does a single dose of oral SGLT2i (50 mg Jardiance) change oxygen tension in the kidney transplant cortex and medulla, estimated by magnetic resonance imaging? * Does a single dose of oral SGLT2i (50 mg Jardiance) change kidney transplant cortical and medullary perfusion? * Does a single dose of oral SGLT2i (50 mg Jardiance) change kidney transplant artery blood flow? * Does a single dose of oral SGLT2i (50 mg Jardiance) change blood glucoses, blood pressure and heart rate? Researchers will compare a single dose of oral SGLT2i (50 mg Jardiance) to a placebo (a look-alike substance that contains no drug) to see if a single dose of oral SGLT2i (50 mg Jardiance) changes oxygen tension in the kidney transplant. Kidney transplant recipients with out diabetes will: * Meet for two intervention days. * A single dose of oral SGLT2i (50 mg Jardiance) or placebo will be given in random order, separated by at least 2 week washout period, the experiment will be repeated with the opposite treatment. * Kidney cortex oxygenation, and blood flow in different compartments of the kidney transplant, is estimated by blood-oxygen-dependent level magnetic resonance imaging (BOLD-MRI). Patients are evaluated by routine clinical examination and routine biochemical measures for kidney transplant patients.
Background: Kidney transplantation is the best treatment of end-stage renal disease (ESRD), although median allograft survival is only 15 years. In non-transplant diabetic and non-diabetic patient's sodium-glucose co-transporter type 2 inhibitors (SGLT2i) protect kidney function, possibly by reducing the proximal tubule transport workload with subsequent improvement of renal oxygenation and relieve hypoxia. Hypothesis: SGLT2i in kidney transplant recipients (KTR) will improve kidney allograft cortex oxygenation. Research Objective: We aim to test the acute effect of SGLT2i on kidney allograft oxygen tension. Design: A randomized, double-blind, placebo-controlled, crossover intervention study. Designed according to the CONSORT statement Methods: A single dose of oral SGLT2i (50 mg Jardiance) and placebo in random order, separated by at least 2 week washout period, the experiment will be repeated with the opposite treatment. Kidney cortex oxygenation and blood flow in different compartments of the kidney allograft will be estimated by blood-oxygen-dependent level magnetic resonance imaging (BOLD-MRI). Patients will be evaluated by routine clinical examination and routine biochemical measures for transplant patients. Primary endpoint: \- Kidney allograft cortical and medullary oxygen tension, estimated by BOLD-MRI based renal T2\* relaxation rate. Secondary endpoint: * Renal cortical and medullary perfusion ml/100 g/min * Renal artery blood flow ml/min * Blood glucose mmol/L * Systolic blood pressure (SysBP) and diastolic blood pressure (DiaBP) mmHg * Heart rate (HR), beats min-1 Study population: 8 Non-diabetic kidney transplant recipients \> 6 months post-transplant and stable eGFR \>20 ml/min will be recruited from Odense University Hospital (OUH) kidney transplant outpatient clinic.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Department of Nephrology, Odense University Hospital Kløvervænget 6, Enterance 93, 3. floor
Odense C, Denmark
Start Date
March 27, 2025
Primary Completion Date
April 1, 2026
Completion Date
June 1, 2026
Last Updated
July 31, 2025
8
ESTIMATED participants
JARDIANCE 25mg
DRUG
Placebo
DRUG
Lead Sponsor
Odense University Hospital
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07415421