Acute Effects of SGLT2 Inhibitor on Kidney Allograft Oxygen Tension

Launched by ODENSE UNIVERSITY HOSPITAL · Apr 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Jardiance (an SGLT2 inhibitor) on kidney transplant recipients who do not have diabetes. Specifically, the researchers want to see if a single dose of Jardiance can change the amount of oxygen in the kidney transplant and how blood flows within it. To do this, they will use a special type of MRI that measures blood oxygen levels. Participants will take either Jardiance or a placebo (a pill with no active medicine) on two different days, separated by two weeks, to compare the effects of the medication versus the placebo.

To be eligible for this trial, participants must be at least 18 years old, have received a kidney transplant more than six months ago, and have stable kidney function. They should not have diabetes or any severe kidney problems. During the trial, participants can expect to attend two sessions where they will receive either the study medication or the placebo, followed by some routine health checks. It’s important to know that women who are pregnant or breastfeeding cannot participate, and those with certain health issues, like severe liver problems or claustrophobia, will also be excluded.

Gender

ALL

Eligibility criteria

• 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