Kidney Transplantation RecipientsPhase 4SGL-TX-MRNCT06933355
Acute Effects of SGLT2 Inhibitor on Kidney Allograft Oxygen Tension
A Phase 4 study testing JARDIANCE 25mg in people with Kidney Transplantation Recipients and Magnetic Resonance Imaging (MRI), run by Odense University Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation Recipients, Magnetic Resonance Imaging (MRI), Sodium-Glucose Transporter 2 Inhibitors
- What is being tested?
- JARDIANCE 25mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Mar 2025to 1 Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Bilirubin > 2 x upper normal limit
- Prednisone treatment
- Pregnancy
- Breastfeeding
- Exclusion criteria for MRI o Claustrophobia/physical not able to lie in MR-s
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nephrology, Odense University Hospital Kløvervænget 6, Enterance 93, 3. floor
Odense C, 5000
About this study
Official title: 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:
Read more
- 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.
Read the 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
- Being tested
- JARDIANCE 25mg, Placebo
- Keywords
- SGLT2i, Kidney Transplant, Kidney Transplant Recipients, MRI, Magnetic resonance Imaging, BOLD-MRI, Blood oxygen level dependent MRI, non-diabetic patients, Sodium-glucose Transporter 2 inhibitors, RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JARDIANCE 25mgDrug
Also called SGLT2i
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| SGLT2i | Active comparator | Single dose of SGLT2i (Jardiance 50 mg) Receives: Drug: JARDIANCE 25mg |
| Placebo | Placebo comparator | Single dose placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney allograft cortex oxygenation, T2*
BOLD-MRI, T2* cortex, s-1
Measured: T2* measured at baseline, 3 and 6 hours post-intervention
Secondary outcomes (1)
Renal cortical perfusion, (ml/100g/min)
BOLD-MRI estimated renal cortical perfusion, (ml/100 g/min)
Measured: Renal cortical perfusion, measured at baseline, 3 and 6 hours post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start27 Mar 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplantation RecipientsStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double blinded, placebo controlled, cross-over intervention study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lotte B Lange, MD, Principal investigator, Department of Nephrology, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933355
- Sponsor's protocol ID
- EU CT:2024-513765-40-00
- Acronym
- SGL-TX-MR
- Status last verified
- Jul 2025
- First submitted
- 1 Apr 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
Lange LB, Bistrup C. SGL-TX-MR-study protocol acute effects of SGLT2 inhibitor on kidney allograft oxygen tension, a randomized, double-blind, placebo controlled crossover trial. Trials. 2025 Dec 29;26(1):585. doi: 10.1186/s13063-025-09244-4.
PubMed 41462489
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of SGLT2 Inhibitor on Kidney Allograft Oxygen Tension: A Randomized, Double-blind, Placebo Controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT06933355
- Acronym / sponsor ID
- SGL-TX-MR / EU CT:2024-513765-40-00
- Conditions
- Kidney Transplantation Recipients, Magnetic Resonance Imaging (MRI), Sodium-Glucose Transporter 2 Inhibitors, Non-Diabetic Patients, Randomized Controlled Trial, Placebo Control Design
- Keywords
- SGLT2i, Kidney Transplant, Kidney Transplant Recipients, MRI, Magnetic resonance Imaging, BOLD-MRI, Blood oxygen level dependent MRI, non-diabetic patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double blinded, placebo controlled, cross-over intervention study.
| Arm | Type | Receives |
|---|---|---|
| SGLT2i | Active comparator | Drug: JARDIANCE 25mgSingle dose of SGLT2i (Jardiance 50 mg) |
| Placebo | Placebo comparator | Drug: PlaceboSingle dose placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (11 listed)
- Diabetic kidney disease type 1 or 2 (World Health Organization (WHO) criteria)
- Renal allograft failure (eGFR< 20 ml/min)
- Alanine aminotransferase (ALAT) > 3 x upper normal limit
- Bilirubin > 2 x upper normal limit
- Prednisone treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JARDIANCE 25mgAlso: SGLT2iThe 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 | SGLT2i |
| PlaceboThe 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 |
Primary outcome
Kidney allograft cortex oxygenation, T2*
Time frame: T2* measured at baseline, 3 and 6 hours post-intervention
BOLD-MRI, T2* cortex, s-1
1 secondary outcome
Renal cortical perfusion, (ml/100g/min)
Time frame: Renal cortical perfusion, measured at baseline, 3 and 6 hours post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Derived from this study: PubMed 41462489Lange LB, Bistrup C. SGL-TX-MR-study protocol acute effects of SGLT2 inhibitor on kidney allograft oxygen tension, a randomized, double-blind, placebo controlled crossover trial. Trials. 2025 Dec 29;26(1):585. doi: 10.1186/s13063-025-09244-4.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lotte B Lange, MD principal investigator
Department of Nephrology, Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing JARDIANCE 25mg in people with Kidney Transplantation Recipients and Magnetic Resonance Imaging (MRI), run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kidney allograft cortex oxygenation, T2* (time frame: T2* measured at baseline, 3 and 6 hours post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06933355, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.