Acute Effects of SGLT2 Inhibitor on Kidney Allograft Oxygen Tension (SGL-TX-MR)

July 30, 2025 updated by: Odense University Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
      • Odense C, Denmark, 5000
        • Department of Nephrology, Odense University Hospital Kløvervænget 6, Enterance 93, 3. floor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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
  • Exclusion criteria for MRI o Claustrophobia/physical not able to lie in MR-s

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: SGLT2i
Single dose of SGLT2i (Jardiance 50 mg)
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.

Other Names:
  • SGLT2i
Placebo Comparator: Placebo
Single dose placebo
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Kidney allograft cortex oxygenation, T2*
Time Frame: T2* measured at baseline, 3 and 6 hours post-intervention
BOLD-MRI, T2* cortex, s-1
T2* measured at baseline, 3 and 6 hours post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Renal cortical perfusion, (ml/100g/min)
Time Frame: Renal cortical perfusion, measured at baseline, 3 and 6 hours post-intervention
BOLD-MRI estimated renal cortical perfusion, (ml/100 g/min)
Renal cortical perfusion, measured at baseline, 3 and 6 hours post-intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Renal allograft artery blood flow (ml/min)
Time Frame: Renal allograft artery blood flow measured at baseline, 3 and 6 hours post-intervention
BOLD-MRI, renal allograft artery blood flow (ml/min)
Renal allograft artery blood flow measured at baseline, 3 and 6 hours post-intervention
Blood glucose (mmol/L)
Time Frame: Blood glucose, measured at baseline, 3 and 6 hours post-intervention
Blood glucose (mmol/L), estimated by handheld blood glucose meter
Blood glucose, measured at baseline, 3 and 6 hours post-intervention
Blood pressure
Time Frame: Bloodpressure measured at baseline, 3 and 6 hours post-intervention
Systolic and diastolic blood pressure (mmHg), Estimated by a validated blood pressure device.
Bloodpressure measured at baseline, 3 and 6 hours post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Odense University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lotte B Lange, MD, Department of Nephrology, Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EU CT:2024-513765-40-00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data Sharing Statement:

Data Available:

Individual participant data (IPD) that underlie the results reported in the published article will be shared after de-identification. This includes text, tables, figures, and appendices.

Supporting Documents:

The study protocol and statistical analysis plan will also be made available.

Time Frame:

Data will be shared immediately following publication. There is no specified end date for availability.

Criteria for Access:

Data will be shared with researchers who submit a methodologically sound proposal aimed at achieving the goals outlined in their approved research proposal.

Access Mechanism:

Interested researchers should direct their proposals to: lotte.borg.lange@rsyd.dk.

To gain access, requestors will be required to sign a data access agreement.

Data Storage:

The data will be stored for 25 years on a secure third-party platform (OPEN).

IPD Sharing Time Frame

The data will be available after the last patients last visit, which is estimated for summer 2025

Data Storage:

The data will be stored for 25 years on a secure third-party platform (OPEN).

IPD Sharing Access Criteria

Criteria for Access:

Data will be shared with researchers who submit a methodologically sound proposal aimed at achieving the goals outlined in their approved research proposal.

Access Mechanism:

Interested researchers should direct their proposals to: lotte.borg.lange@rsyd.dk.

To gain access, requestors will be required to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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