ArticleTrials2025
SGL-TX-MR-study protocol acute effects of SGLT2 inhibitor on kidney allograft oxygen tension, a randomized, double-blind, placebo controlled crossover trial.
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06933355 (Acute Effects of SGLT2 Inhibitor on Kidney Allograft Oxygen Tension), which is not on this map. Not yet cited in PubMed.
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Acute Effects of SGLT2 Inhibitor on Kidney Allograft Oxygen Tension: A Randomized, Double-blind, Placebo Controlled Crossover Trial
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2 authors.
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Abstract
backgroundThe acute effect of sodium-glucose co-transporter type 2 inhibitors, SGLT2i, has never been investigated in non-diabetic kidney transplant recipients.
methodsSGL-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.
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