SGL-TX-MR Study: The acute effect of SGLT2i on kidney transplant oxygen levels.

Phase 2

Active, not recruiting

Brief Summary: To evaluate the acute effect of SGLT2i on kidney allograft oxygen tension in cortex and medulla.

Recruitment & Eligibility

Inclusion Criteria

Written informed consent must be provided before participation
Male or female patients ≥ 18 years of age
Non-diabetic kidney transplant recipients, > 6 months post-transplant
Stable eGFR> 20 ml/min (stable defined as eGFR 20 ml/min ± 5 ml/min variation in the last 3 months)
Tacrolimus(Adport) and Mycophenolatmofetile (Myfenax, cellcept) as part of immunosuppressive treatment

Exclusion Criteria

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 or bilirubin > 2 x upper normal limit
Pregnancy or breastfeeding
Exclusion criteria for MRI o Claustrophobia/physical not able to lie in MR-scanner for 2 hours o MRI safety hazards such as cardiac pacemaker, implantable cardioverter defibrillator (ICD), non-MRI compatible implants and implanted devices, intraorbital or intracranial metallic foreign bodies.
Allergy towards SGLT2i or the content substance
Known intestinal bowel disease
Prednisone treatment

Primary Outcome Measures

Name	Time	Method
• Kidney allograft cortical and medullary oxygen tension, estimated by BOLD-MRI based renal T2* relaxation rate.		• Kidney allograft cortical and medullary oxygen tension, estimated by BOLD-MRI based renal T2* relaxation rate.

Secondary Outcome Measures

Name	Time	Method
• Renal cortical and medullary perfusion ml/100 g/min		• Renal cortical and medullary perfusion ml/100 g/min
• Renal artery blood flow ml/min		• Renal artery blood flow ml/min
• Blood glucose mmol/L		• Blood glucose mmol/L
• Systolic blood pressure (SysBP) and diastolic blood pressure (DiaBP) mmHg		• Systolic blood pressure (SysBP) and diastolic blood pressure (DiaBP) mmHg
• Heart rate (HR), beats min-1		• Heart rate (HR), beats min-1

Locations (1): Odense University Hospital
🇩🇰
Odense C, Denmark
Odense University Hospital
🇩🇰Odense C, Denmark
Lotte Borg Lange
Site contact
+4540863392
Lotte.Borg.Lange@rsyd.dk