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Study on the Immediate Effects of Empagliflozin on Kidney Transplant Oxygen Levels in Kidney Transplant Recipients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Jardiance on individuals who have received a kidney transplant. Jardiance contains the active ingredient empagliflozin, which is a type of medication known as an SGLT2 inhibitor. The purpose of the study is to evaluate how Jardiance affects the oxygen levels in the transplanted kidney. Participants in the study will either receive Jardiance or a placebo, which looks like the medication but does not contain any active ingredients.

The study will involve kidney transplant recipients who are not diabetic and have had their transplant for more than six months. Participants will be monitored to see how Jardiance affects the oxygen levels in different parts of the kidney, specifically the cortex and medulla, which are areas within the kidney. This will be done using a special imaging technique called MRI, which allows doctors to see inside the body without surgery. The study will also look at other factors such as blood flow to the kidney, blood sugar levels, blood pressure, and heart rate.

The trial is designed to be a crossover study, meaning that participants will receive both the medication and the placebo at different times during the study. This helps researchers compare the effects of the medication directly with the placebo. The study is expected to start recruiting participants in early 2025 and will continue until 2027. The findings from this study could provide valuable insights into how Jardiance affects kidney function in transplant recipients.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that you are a non-diabetic kidney transplant recipient, at least 18 years old, and more than 6 months post-transplant.
Your kidney function is checked to ensure a stable estimated glomerular filtration rate (eGFR) greater than 20 ml/min, with minimal variation in the last 3 months.
Step 2
Medication administration
You will receive either Jardiance 25 mg film-coated tablets or a placebo. The placebo contains no active substance and is produced by the hospital pharmacy.
The medication is taken orally. The specific schedule and duration of administration will be provided during the trial.
Step 3
Monitoring and evaluation
Throughout the trial, your kidney's oxygen levels will be monitored using a technique called BOLD-MRI, which measures the relaxation rate of renal T2*.
Additional evaluations include measuring renal perfusion, renal artery blood flow, blood glucose levels, blood pressure, and heart rate.
Step 4
Completion of trial
The trial is expected to conclude by September 30, 2027. Upon completion, a final assessment will be conducted to evaluate the effects of the medication on your kidney function and overall health.

Who can join the trial?

5 criteria

Provide written informed consent before participating. This means you agree to join the study after understanding what it involves.
Be a male or female who is at least 18 years old.
Be a non-diabetic kidney transplant recipient who received the transplant more than 6 months ago.
Have a stable eGFR greater than 20 ml/min. eGFR is a test that measures how well your kidneys are working. "Stable" means your eGFR has not changed by more than 5 ml/min in the last 3 months.
Be taking Tacrolimus (also known as Adport) and Mycophenolate mofetil (known as Myfenax or Cellcept) as part of your treatment to prevent your body from rejecting the kidney transplant.

Who cannot join the trial?

4 criteria

Individuals who have received a kidney transplant cannot participate. A kidney transplant is a surgery to place a healthy kidney from a donor into someone whose kidneys no longer function properly.
Participants must be within certain age ranges, specifically between 18 and 65 years old.
Both male and female participants are eligible, but certain conditions may exclude individuals.
Participants should not belong to a vulnerable population. This means they should not be in a situation where they might be at risk of harm or exploitation.

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Odense University Hospital
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Odense, Denmark

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Investigated drugs

SGLT2 inhibitor: This medication is used to lower blood sugar levels in people with type 2 diabetes. It works by helping the kidneys remove sugar from the body through urine. In this trial, the SGLT2 inhibitor is being studied to see how it affects the oxygen levels in transplanted kidneys.

Empagliflozin

What is already known about the treatment

SGLT2 Inhibitor – This medication is administered orally and is currently being studied in clinical trials to assess its effects on kidney transplant recipients. It is primarily used to manage blood sugar levels in individuals with type 2 diabetes, but its potential benefits for kidney transplant patients are under investigation. The drug works by blocking the sodium-glucose co-transporter 2 (SGLT2) in the kidneys, which reduces glucose reabsorption and increases glucose excretion in the urine. It belongs to the pharmacological class of SGLT2 inhibitors.

Investigated diseases

Kidney Transplant Recipients – This condition involves individuals who have received a kidney transplant to replace a non-functioning kidney. After transplantation, the new kidney, known as the allograft, must adapt to its new environment in the recipient's body. The primary concern is ensuring the allograft receives adequate blood flow and oxygen to function properly. Over time, the body may react to the transplanted kidney, potentially leading to complications such as rejection or reduced kidney function. Monitoring involves assessing the oxygen levels and blood flow in the kidney to ensure it remains healthy. The focus is on maintaining the kidney's ability to filter waste and regulate essential bodily functions.