SGL-TX-MR-study protocol acute effects of SGLT2 inhibitor on kidney allograft oxygen tension, a randomized,
Lotte Borg Lange1, Claus Bistrup2
1Department of Nephrology, Odense University Hospital, Kløvervænget 6, Odense C, DK-5000, Denmark. Lotte.Borg.Lange@rsyd.dk.
Background:
The acute effect of sodium-glucose co-transporter type 2 inhibitors, SGLT2i, has never been investigated in non-diabetic kidney transplant recipients.
Methods:
SGL-TX-MR will investigate the acute effects of SGLT2 inhibitor on kidney allograft oxygen tension in a randomized, double-blind, placebo controlled crossover trial. Eight non-diabetic-KTR, adults, more than 6 months post-transplant with a stable estimated glomerular filtration rate > 20 ml/min, recruited from Odense University Hospital, Kidney Transplant Outpatient Clinic, from 2025 to 2026, will be randomized to a double blind crossover intervention with a single dose 50 mg Jardiance, SGLT2i, or placebo in random order, separated by a 2-week wash-out period.
Primary Outcome:
kidney transplant cortical and medullary oxygen tension, estimated by blood oxygen level dependent-magnetic resonance imaging-based renal T2* relaxation rate. Secondary endpoint: Renal cortical and medullary perfusion, renal artery blood flow, blood glucose, blood pressure, and heart rate.
Discussion:
We will investigate if a single dose of SGLT2i improves renal cortical oxygenation within 3 and 6 h from admission in non-diabetic kidney transplant recipients. This finding will improve the understanding of the mechanisms behind the impressive renoprotective effects recently seen with SGLT2i in major clinical trials with non-transplant chronic kidney disease patients and provide new horizons for therapeutic treatments targeting hypoxia in renal allograft. TRIAL REGISTRATION {4}: ClinicalTrials.gov NCT06933355. Registered on April 18, 2025.
Insights
This study will investigate if sodium-glucose co-transporter type 2 inhibitors (SGLT2i) improve kidney allograft oxygenation in non-diabetic kidney transplant recipients. Findings may reveal new therapeutic strategies for renal allograft hypoxia.
Area of Science:
- Nephrology
- Transplantation Medicine
- Pharmacology
Background:
- The acute impact of SGLT2 inhibitors on kidney allografts in non-diabetic recipients remains unexamined.
- Non-diabetic kidney transplant recipients (KTR) may benefit from understanding SGLT2 inhibitor mechanisms.
Purpose of the Study:
- To evaluate the acute effect of SGLT2 inhibitors on kidney allograft oxygen tension in non-diabetic KTR.
- To explore potential renoprotective mechanisms of SGLT2 inhibitors in the context of renal transplantation.
Main Methods:
- A randomized, double-blind, placebo-controlled crossover trial (SGL-TX-MR) involving eight non-diabetic KTR.
- Administration of a single dose of Jardiance (SGLT2i) or placebo, with a 2-week washout period.
- Assessment of kidney transplant cortical and medullary oxygen tension using MRI-based T2* relaxation rate.
Main Results:
- This section will report on changes in renal oxygen tension, perfusion, blood flow, glucose, blood pressure, and heart rate post-intervention.
- Analysis of whether SGLT2i administration acutely enhances renal cortical oxygenation within 3-6 hours.
Conclusions:
- The study aims to determine if SGLT2 inhibitors improve renal oxygenation in non-diabetic kidney transplant recipients.
- Results could elucidate SGLT2i renoprotective mechanisms and inform treatments for renal allograft hypoxia.
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