Acute Effects of SGLT2 Inhibitor on Kidney Allograft Oxygen Tension

NCT ID: NCT06933355

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-27
• Study Completion Date: 2026-06-01

Brief 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

Kidney Transplantation Recipients; Magnetic Resonance Imaging (MRI); Sodium-Glucose Transporter 2 Inhibitors; Non-Diabetic Patients; Randomized Controlled Trial; Placebo Control Design

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SGLT2i

Single dose of SGLT2i (Jardiance 50 mg)

Group Type: ACTIVE_COMPARATOR

JARDIANCE 25mg

Intervention Type: DRUG

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.

Placebo

Single dose placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

SGLT2i

Eligibility Criteria

Inclusion Criteria

• Male or female patients, age ≥ 18 years.
• Non-diabetic kidney transplant recipients
• > 6 months post-transplant
• Stable eGFR> 20 ml/min (defined as eGFR 20 ml/min ± 5 ml/min variation in the last 3 months)
• Immunosuppressive: Tacrolimus (Adport) and Mycophenolatmofetil (Myfenax/Cellcept/Mycophenolatmofetil)
• Capable of lying in a MR-scanner
• Capable of providing a signed informed consent and comply with study requirements.

• Negativ pregnancy test

Exclusion Criteria

• Diabetic kidney disease type 1 or 2 (World Health Organization (WHO) criteria)

• Hemoglobin A1c ≥ 48 mmol/mol
• Fasting venous plasma glucose ≥ 7,0 mmol/l or
• 2-hours venous plasma glucose ≥ 11,1 mmol/l after oral glucose tolerance test (OGTT).
• Renal allograft failure (eGFR< 20 ml/min)
• Alanine aminotransferase (ALAT) > 3 x upper normal limit
• Bilirubin > 2 x upper normal limit
• Prednisone treatment
• Pregnancy
• Breastfeeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lotte B Lange, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology, Odense University Hospital

Locations

Department of Nephrology, Odense University Hospital Kløvervænget 6, Enterance 93, 3. floor

Odense C, , Denmark

Countries

Denmark

Other Identifiers

EU CT:2024-513765-40-00

Identifier Type: -

Identifier Source: org_study_id