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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

Lange LB, Bistrup C

Trials, 2025

Abstract

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…

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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.

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