Acute effects of SGLT2 inhibitor on kidney allograft oxygen tension: A randomized, double-blind, placebo controlled crossover trial
This research is investigating how a drug called Jardiance (25mg) affects the oxygen levels in kidneys that people have received as a transplant. We are trying to understand if this medicine could help transplanted kidneys function better by improving their oxygen supply. Participants will receive either Jardiance or a dummy pill (placebo) in a crossover design, meaning they will try both at different times. We will use a special type of MRI scan, called a BOLD-MRI, to measure oxygen levels in the kidneys. We'll also check things like blood flow to the kidneys, blood pressure, heart rate, and blood sugar levels. This is an early-stage study to explore the drug's effects.
At a glance
What is this study about?
This study is designed to understand how a medicine called Jardiance, which is already used for some conditions like diabetes and heart failure, might help people who have had a kidney transplant. When someone receives a new kidney, it's really important to make sure it gets enough oxygen to work properly. Sometimes, transplanted kidneys might not get as much oxygen as they need.
We are looking into whether Jardiance can increase the oxygen levels in these transplanted kidneys. To do this, we'll use a special and safe type of MRI scan called a BOLD-MRI. This scan can show us how much oxygen is in different parts of the kidney without injections or radiation. We'll compare the effects of Jardiance to a 'dummy' pill (called a placebo) to see if there's a real difference.
By measuring kidney oxygen levels, blood flow, blood pressure, and blood sugar, we hope to learn if Jardiance could be a useful treatment to help transplanted kidneys stay healthy and work well for longer. This is an exploratory study, meaning it's an early step to see if this idea has promise for future, larger research.
Key takeaways
- The study explores if Jardiance can improve oxygen in transplanted kidneys.
- It uses special MRI scans to measure kidney oxygen levels.
- Participants will try both Jardiance and a dummy pill (placebo).
- It's an early-stage study to gather initial information.
- The study aims to help future kidney transplant patients.
Who may be eligible?
To be part of this study, you need to be an adult, 18 years old or older. There is no upper age limit, so people of all adult ages are welcome to consider taking part.
This study is specifically for people who have received a kidney transplant. Both men and women are invited to join the research.
Beyond these general points, there will be other specific health requirements that the study doctors will check to make sure the study is safe and suitable for you. This will include reviewing your medical history and any current medications you are taking.
- Am I 18 years old or older?
- Have I had a kidney transplant?
- Am I able to visit the hospital for study appointments?
- Am I comfortable with having MRI scans and blood tests?
- Am I willing to take a study medication or a placebo?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to join this study, you will visit the hospital on several occasions. During these visits, you will receive either the study medicine (Jardiance) or a placebo (a dummy pill with no active ingredient). Because it's a 'crossover' study, at different times you will receive both the Jardiance and the placebo, so we can compare their effects directly within each person. Neither you nor your study doctor will know whether you are taking Jardiance or the placebo at any given time.
A key part of your participation will involve undergoing special MRI scans called BOLD-MRI. These scans will measure the oxygen levels in your transplanted kidney. We will also take measurements of your blood pressure, heart rate, and blood sugar levels during your visits. Blood samples will be taken to check these levels.
The research team will closely monitor your health throughout the study. You'll have regular check-ups to make sure you are feeling well and that the treatment is not causing any unexpected problems. The total duration of your involvement in the study, including all visits and follow-up, will be explained in detail by the study team.
Potential risks and benefits
Locations (1)
- —Denmark
Common questions
What is Jardiance?
Jardiance is a medicine that is already approved for other health conditions like diabetes and heart failure. We are studying if it can help transplanted kidneys.
What is a placebo?
A placebo is a 'dummy' pill that looks just like the study medicine but contains no active ingredients. It helps us see if the real medicine is having an effect.
What is a BOLD-MRI scan?
A BOLD-MRI is a special and safe type of scan that can measure oxygen levels in your kidneys without using injections or radiation. It's like a detailed picture of your kidney's oxygen supply.
Will I know if I'm getting the real medicine?
No, this is a 'double-blind' study, meaning neither you nor your study doctor will know whether you are taking Jardiance or the placebo at any given time. This helps keep the study fair.
What does a 'crossover' study mean?
It means you will receive both the study medicine (Jardiance) and the placebo at different times during the study. This allows us to compare their effects in the same person.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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