Acute Effects of SGLT2 Inhibitor on Kidney Allograft Oxygen Tension

NCT06933355 | Active Not Recruiting Phase 4

• 1 other identifier: EU CT:2024-513765-40-00
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

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; Sodium-glucose Transporter 2 inhibitors; RCT

Outcome Measures

Primary Outcomes (1)

• Kidney allograft cortex oxygenation, T2*

  BOLD-MRI, T2\* cortex, s-1

  T2* measured at baseline, 3 and 6 hours post-intervention

Secondary Outcomes (1)

• Renal cortical perfusion, (ml/100g/min)

  Renal cortical perfusion, measured at baseline, 3 and 6 hours post-intervention

Other Outcomes (3)

• 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)

  Blood glucose, measured at baseline, 3 and 6 hours post-intervention

• Blood pressure

  Bloodpressure measured at baseline, 3 and 6 hours post-intervention

Study Arms (2)

SGLT2i

ACTIVE COMPARATOR

Single dose of SGLT2i (Jardiance 50 mg)

Drug: JARDIANCE 25mg

Placebo

PLACEBO COMPARATOR

Single dose placebo

Drug: Placebo

Interventions

JARDIANCE 25mg 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.

Also known as: SGLT2i

SGLT2i

Placebo 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

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

Odense C, 5000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 41462489 DERIVED

MeSH Terms

Interventions

empagliflozin

Study Officials

• Lotte B Lange, MD

  Department of Nephrology, Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double blinded, placebo controlled, cross-over intervention study.

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 18, 2025
• Study Start: March 27, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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).
• 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.

Locations

DK (1)