Status:
ACTIVE_NOT_RECRUITING
Acute Effects of SGLT2 Inhibitor on Kidney Allograft Oxygen Tension
Lead Sponsor:
Odense University Hospital
Conditions:
Kidney Transplantation Recipients
Magnetic Resonance Imaging (MRI)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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: * ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06933355
Start Date
March 27 2025
End Date
June 1 2026
Last Update
July 31 2025
Active Locations (1)
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1
Department of Nephrology, Odense University Hospital Kløvervænget 6, Enterance 93, 3. floor
Odense C, Denmark, 5000