Acute Effects of SGLT2 Inhibitor on Kidney Allograft Oxygen Tension (NCT06933355) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Acute Effects of SGLT2 Inhibitor on Kidney Allograft Oxygen Tension
Denmark8 participantsStarted 2025-03-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Kidney allograft cortex oxygenation, T2*
Timeframe: T2* measured at baseline, 3 and 6 hours post-intervention