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Study of the effect of dapagliflozin on the development of post-transplant diabetes 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 study focuses on people who have undergone a kidney transplant, which is a surgical procedure where a healthy kidney from a donor is placed into a person whose own kidneys no longer work properly. The research aims to determine the effect of dapagliflozin compared to a placebo when added to standard medical care. A specific concern in this group is the development of post-transplant diabetes mellitus, a type of high blood sugar that can occur after receiving a new kidney. The study also looks at kidney allograft function, which refers to how well the transplanted kidney is working.

Participants will be assigned to receive either dapagliflozin or a placebo in the form of an oral tablet. Throughout the study, various health factors will be monitored, such as eGFR, which is a measure used to check how well the kidneys are filtering blood, and proteinuria, which is the presence of excess protein in the urine. Other areas of interest include monitoring creatinine levels, a waste product in the blood that indicates kidney health, and checking for cholesterol levels. The study will also track blood pressure, the force of blood against artery walls, and the occurrence of any urinary tract infection.

The research will continue for a set period to observe changes in health outcomes. This includes monitoring for kidney transplant rejection, where the body's immune system attacks the new organ, and checking for end-stage renal disease, a condition where the kidneys can no longer support the body's needs. Additionally, the study will track major adverse cardiac events, which are serious heart-related problems, and general safety through the reporting of adverse events. The participants will receive regular follow-ups to ensure all necessary measurements are taken over the course of the trial.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Participation in the study
Once participation begins, a daily oral medication is taken as an addition to the standard medical care for kidney transplant recipients.
You will receive either forxiga, which contains 10 mg of dapagliflozin, or a placebo, which is an inactive tablet that looks identical to the medication.
Step 2
Follow-up monitoring
At the 6-month mark, assessments are conducted to monitor for the development of post-transplant diabetes mellitus (a type of diabetes that develops after a kidney transplant) and prediabetes.
During this time, measurements are taken for kidney function, including eGFR (a measure of how well the kidneys filter blood), creatinine (a waste product in the blood), and proteinuria (the presence of excess protein in the urine).
Other checks include monitoring blood pressure, cholesterol, and tacrolimus levels (a medication used to prevent organ rejection).
The frequency of urinary tract infections, kidney rejection, and adverse events (unwanted side effects) is also tracked.
Step 3
Final assessment
At the 12-month mark, a final set of assessments is performed to evaluate the long-term effects on diabetes incidence, kidney function, and blood pressure.
The monitoring continues to observe kidney transplant health, such as the need for dialysis or retransplantation, and cardiac events (problems related to the heart).
A health survey is completed to evaluate overall well-being compared to the start of the study.

Who can join the trial?

6 criteria

You must provide written informed consent, which means you agree to participate in the study after being told all the details.
You must be male or female and at least 18 years old.
You must be a kidney transplant recipient, meaning you have previously received a new kidney through surgery.
You must not have diabetes.
Your eGFR, which is a measurement used to check how well your kidneys are filtering waste from your blood, must be greater than 25 ml/min/1.73m2 based on tests from the last 3 months.
You must be taking immunosuppressive medication, which are drugs used to prevent your body from rejecting your new kidney, and this must include a specific medicine called Tacrolimus.

Who cannot join the trial?

10 criteria

You are currently being treated with a special diet or medications to manage Type 1 or Type 2 diabetes.
Your eGFR, which is a measurement used to check how well your kidneys are filtering waste from your blood, is lower than 25 ml/min/1.73m2.
Your level of Alanine aminotransferase (ALAT), an enzyme found in the liver, is more than three times the normal limit.
Your level of Bilirubin, a yellow substance produced during the normal breakdown of red blood cells that can indicate liver issues, is more than twice the normal limit.
You are pregnant.
A blood test shows a positive plasma hCG, which is a hormone found in the body during pregnancy.
You are breastfeeding.
You have a known allergy to SGLT2i (the type of medication being studied) or any of its ingredients.
You have chronic intestinal diseases, which are long-term problems with the intestines, such as inflammatory bowel diseases like Crohn’s disease or ulcerative colitis.
You have structural conditions of the gut, such as short bowel syndrome, where part of the intestine is missing or not working correctly.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Aarhus University Hospital
Verified
Aarhus, Denmark
Odense University Hospital
Verified
Odense, Denmark
Roskilde University
Responsive
Roskilde, Denmark

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Investigated drugs

Dapagliflozin is a medication taken by mouth that belongs to a class of drugs called SGLT2 inhibitors. In this study, it is being tested to see if it can help prevent the development of new-onset diabetes and protect kidney function in people who have received a kidney transplant.

Dapagliflozin

What is already known about the treatment

Dapagliflozin
This medication is taken as a pill by mouth once a day. It is a well-known drug used to treat type 2 diabetes and help protect the heart and kidneys in many patients. It works by blocking a specific protein in the kidneys that normally brings sugar back into the bloodstream, which allows the body to remove excess sugar through urine instead. This drug belongs to a group of medicines called sodium-glucose cotransporter 2 inhibitors.
Placebo
This is an inactive substance taken by mouth in the form of a capsule that looks exactly like the real medication. It contains common ingredients like sugar and starch and is used in clinical trials to provide a comparison for testing new treatments. Because it contains no active medicine, it has no direct effect on the body's biological processes or disease symptoms.

Investigated diseases

Post-transplant diabetes mellitus - This is a condition where high blood sugar levels develop in individuals after they have received a kidney transplant. It typically occurs as a result of the medications used to prevent organ rejection or changes in the body's metabolism following the procedure. The condition may progress from normal glucose levels to prediabetes and eventually to full diabetes. It is often characterized by an increasing inability of the body to regulate blood sugar effectively over time.