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Background <p>The acute effect of sodium-glucose co-transporter type 2 inhibitors, SGLT2i, has never been investigated in non-diabetic kidney transplant recipients.</p> Methods <p>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&#xa0;months post-transplant with a stable estimated glomerular filtration rate &gt; 20&#xa0;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&#xa0;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.</p> Discussion <p>We will investigate if a single dose of SGLT2i improves renal cortical oxygenation within 3 and 6&#xa0;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.</p> Trial registration {4} <p>ClinicalTrials.gov NCT06933355. Registered on April 18, 2025.</p>

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SGL-TX-MR—study protocol acute effects of SGLT2 inhibitor on kidney allograft oxygen tension, a randomized, double-blind, placebo controlled crossover trial

  • 期刊论文

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  • 发表日期：

    2025年12月29日

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  • Lotte Borg Lange,
  • Claus Bistrup

摘要

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.