Acute Effects of SGLT2 Inhibitor on Kidney Allograft Oxygen Tension

NCT06933355 · tracked via the Priya Life Science Denmark tracker

Sponsor

Odense University Hospital

Phase

Phase 4

Started

2025-03-27

Last updated

2025-07-31

Condition(s) studied

Kidney Transplantation RecipientsMagnetic Resonance Imaging (MRI)Sodium-Glucose Transporter 2 InhibitorsNon-Diabetic PatientsRandomized Controlled TrialPlacebo Control Design

Investigational drug(s) / intervention(s)

JARDIANCE 25mg →Placebo

JARDIANCE 25mg: 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: 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 summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Male or female patients, age ≥ 18 years. * Non-diabetic kidney transplant recipients * \> 6 months post-transplant * Stable eGFR\> 20 ml/min (defined as eGFR 20 ml/min ± 5 ml/min variation in the last 3 months) * Immunosuppressive: Tacrolimus (Adport) and Mycophenolatmofetil (Myfenax/Cellcept/Mycophenolatmofetil) * Capable of lying in a MR-scanner * Capable of providing a signed informed consent and comply with study requirements. * Negativ pregnancy test Exclusion Criteria: * Diabetic kidney disease type 1 or 2 (World Health Organization (WHO) criteria) * Hemoglobin A1c ≥ 48 mmol/mol * Fasting venous plasma glucose ≥ 7,0 mmol/l or * 2-hours venous plasma glucose ≥ 11,1 mmol/l after oral glucose tolerance test (OGTT). * Renal allograft failure (eGFR\< 20 ml/min) * Alanine aminotransferase (ALAT) \> 3 x upper normal limit * Bilirubin \> 2 x upper normal limit * Prednisone treatment * Pregnancy * Breastfeeding * Exclusion criteria for MRI o Claustrophobia/physical not able to lie in MR-s

Primary outcome measure(s)

Kidney allograft cortex oxygenation, T2* — T2* measured at baseline, 3 and 6 hours post-intervention
BOLD-MRI, T2\* cortex, s-1

Trial sites (1)

Facility	City	Region	Status
Department of Nephrology, Odense University Hospital Kløvervænget 6, Enterance 93, 3. floor	Odense C	Denmark

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06933355 on ClinicalTrials.gov ↗ ← All trials in Denmark