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SGL-TX-MR Study: The acute effect of SGLT2i on kidney transplant oxygen levels.
EU CTIS ID: 2024-513765-40-00
What this study is testing
To evaluate the acute effect of SGLT2i on kidney allograft oxygen tension in cortex and medulla.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - 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
You likely can't join if
- - 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
See the full eligibility 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
- - 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.