Trials / Active Not Recruiting

Active Not RecruitingNCT06933355

Acute Effects of SGLT2 Inhibitor on Kidney Allograft Oxygen Tension

Acute Effects of SGLT2 Inhibitor on Kidney Allograft Oxygen Tension: A Randomized, Double-blind, Placebo Controlled Crossover Trial

Status: Active Not Recruiting
Phase: Phase 4
Study type: Interventional
Enrollment: 8 (estimated)

Sponsor: Odense University Hospital · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to investigate if a single dose of oral SGLT2i, (50 mg Jardiance) will change oxygen tension in the kidney transplant. The main questions it aims to answer are: * Does a single dose of oral SGLT2i (50 mg Jardiance) change oxygen tension in the kidney transplant cortex and medulla, estimated by magnetic resonance imaging? * Does a single dose of oral SGLT2i (50 mg Jardiance) change kidney transplant cortical and medullary perfusion? * Does a single dose of oral SGLT2i (50 mg Jardiance) change kidney transplant artery blood flow? * Does a single dose of oral SGLT2i (50 mg Jardiance) change blood glucoses, blood pressure and heart rate? Researchers will compare a single dose of oral SGLT2i (50 mg Jardiance) to a placebo (a look-alike substance that contains no drug) to see if a single dose of oral SGLT2i (50 mg Jardiance) changes oxygen tension in the kidney transplant. Kidney transplant recipients with out diabetes will: * Meet for two intervention days. * A single dose of oral SGLT2i (50 mg Jardiance) or placebo will be given in random order, separated by at least 2 week washout period, the experiment will be repeated with the opposite treatment. * Kidney cortex oxygenation, and blood flow in different compartments of the kidney transplant, is estimated by blood-oxygen-dependent level magnetic resonance imaging (BOLD-MRI). Patients are evaluated by routine clinical examination and routine biochemical measures for kidney transplant patients.

Detailed description

Background: Kidney transplantation is the best treatment of end-stage renal disease (ESRD), although median allograft survival is only 15 years. In non-transplant diabetic and non-diabetic patient's sodium-glucose co-transporter type 2 inhibitors (SGLT2i) protect kidney function, possibly by reducing the proximal tubule transport workload with subsequent improvement of renal oxygenation and relieve hypoxia. Hypothesis: SGLT2i in kidney transplant recipients (KTR) will improve kidney allograft cortex oxygenation. Research Objective: We aim to test the acute effect of SGLT2i on kidney allograft oxygen tension. Design: A randomized, double-blind, placebo-controlled, crossover intervention study. Designed according to the CONSORT statement Methods: A single dose of oral SGLT2i (50 mg Jardiance) and placebo in random order, separated by at least 2 week washout period, the experiment will be repeated with the opposite treatment. Kidney cortex oxygenation and blood flow in different compartments of the kidney allograft will be estimated by blood-oxygen-dependent level magnetic resonance imaging (BOLD-MRI). Patients will be evaluated by routine clinical examination and routine biochemical measures for transplant patients. Primary endpoint: \- Kidney allograft cortical and medullary oxygen tension, estimated by BOLD-MRI based renal T2\* relaxation rate. Secondary endpoint: * Renal cortical and medullary perfusion ml/100 g/min * Renal artery blood flow ml/min * Blood glucose mmol/L * Systolic blood pressure (SysBP) and diastolic blood pressure (DiaBP) mmHg * Heart rate (HR), beats min-1 Study population: 8 Non-diabetic kidney transplant recipients \> 6 months post-transplant and stable eGFR \>20 ml/min will be recruited from Odense University Hospital (OUH) kidney transplant outpatient clinic.

Conditions

Interventions

Type	Name	Description
DRUG	JARDIANCE 25mg	The intervention will be SGLT2i compared with placebo. The trial include a total of 8 non-diabetic kidney transplant recipients. 4 patients will randomly be assigned to start in the active arm, and treated with a single dose SGLT2i at intervention day 1 and a single dose placebo at intervention day 2. 4 patients will randomly be assigned to start in the non-active arm, each participant will be treated with a single dose placebo at intervention day 1 and a single dose SGLT2i at intervention day 2.
DRUG	Placebo	The intervention will be SGLT2i compared with placebo. The trial include a total of 8 non-diabetic kidney transplant recipients. 4 patients will randomly be assigned to start in the active arm, and treated with a single dose SGLT2i at intervention day 1 and a single dose placebo at intervention day 2. 4 patients will randomly be assigned to start in the non-active arm, each participant will be treated with a single dose placebo at intervention day 1 and a single dose SGLT2i at intervention day 2.

Timeline

Start date: 2025-03-27
Primary completion: 2026-04-01
Completion: 2026-06-01
First posted: 2025-04-18
Last updated: 2025-07-31

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT06933355. Inclusion in this directory is not an endorsement.