Acute Effects of SGLT2 Inhibitor on Kidney Allograft Oxygen Tension

Sponsor
Odense University Hospital
Study ID
NCT06933355
Phase
PHASE4
Status
Active Not Recruiting

Conditions

  • Kidney Transplantation Recipients
  • Magnetic Resonance Imaging (MRI)
  • Non-Diabetic Patients
  • Placebo Control Design
  • Randomized Controlled Trial
  • Sodium-Glucose Transporter 2 Inhibitors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • JARDIANCE 25mg — DRUG
    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.
  • Placebo — DRUG
    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.

Study Details

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.

Key Dates

Start date
Mar 27, 2025
Status verified
Jul 2025
Primary completion
Apr 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
8 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: SGLT2i
    Single dose of SGLT2i (Jardiance 50 mg)
  • Placebo Comparator: Placebo
    Single dose placebo

Primary Outcome Measure

Kidney allograft cortex oxygenation, T2* [ Time Frame: T2* measured at baseline, 3 and 6 hours post-intervention ]

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