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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
8
The intervention will be SGLT2i compared with placebo. The trial include a total of 8 non-diabetic kidney transplant recipients. 4 patients will randomly be assigned to start in the active arm, and treated with a single dose SGLT2i at intervention day 1 and a single dose placebo at intervention day 2. 4 patients will randomly be assigned to start in the non-active arm, each participant will be treated with a single dose placebo at intervention day 1 and a single dose SGLT2i at intervention day 2.
The intervention will be SGLT2i compared with placebo. The trial include a total of 8 non-diabetic kidney transplant recipients. 4 patients will randomly be assigned to start in the active arm, and treated with a single dose SGLT2i at intervention day 1 and a single dose placebo at intervention day 2. 4 patients will randomly be assigned to start in the non-active arm, each participant will be treated with a single dose placebo at intervention day 1 and a single dose SGLT2i at intervention day 2.
Department of Nephrology, Odense University Hospital Kløvervænget 6, Enterance 93, 3. floor
Odense C, Denmark
Kidney allograft cortex oxygenation, T2*
BOLD-MRI, T2\* cortex, s-1
Time frame: T2* measured at baseline, 3 and 6 hours post-intervention
Renal cortical perfusion, (ml/100g/min)
BOLD-MRI estimated renal cortical perfusion, (ml/100 g/min)
Time frame: Renal cortical perfusion, measured at baseline, 3 and 6 hours post-intervention
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