Recruiting

Study on the Safety and Effectiveness of Dapagliflozin for Kidney Function in Non-Diabetic Kidney Transplant Patients

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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 Forxiga (dapagliflozin) on individuals who have received a kidney transplant but do not have diabetes. The purpose of the study is to determine the safety and effectiveness of Forxiga in maintaining the function of the transplanted kidney. Participants in the study will be randomly assigned to receive either Forxiga or a placebo, which looks like the medication but does not contain the active ingredient.

The study will take place over a period of 18 months. During this time, participants will take the medication or placebo orally in the form of film-coated tablets. The study will monitor the function of the transplanted kidney by measuring a specific marker called eGFR, which stands for estimated glomerular filtration rate. This marker helps assess how well the kidneys are filtering waste from the blood.

Throughout the study, participants will have regular check-ups to monitor their health and the function of their transplanted kidney. The study aims to provide valuable information on whether Forxiga can be a safe and effective treatment option for improving kidney function in non-diabetic kidney transplant recipients. Participants will be closely monitored for any side effects or changes in their health during the study period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the medication Forxiga 10 mg film-coated tablets, and the other group will receive a placebo, which looks like the medication but does not contain the active ingredient.
The study is designed to be double-blind, meaning neither you nor the study team will know which group you are in. This helps ensure the results are unbiased.
Step 2
Medication administration
If you are in the group receiving Forxiga, you will take one tablet orally each day. The dosage is 10 mg per tablet.
If you are in the placebo group, you will take one placebo capsule orally each day. The placebo is designed to look like the actual medication but does not contain the active ingredient.
Step 3
Regular check-ups
You will have regular check-ups to monitor your health and the function of your kidney transplant. These check-ups will occur every three months after the initial four weeks of the study.
During these visits, various health indicators will be measured, including your kidney function, blood pressure, and cholesterol levels.
Step 4
Monitoring and assessments
Throughout the study, your kidney function will be closely monitored. This includes measuring the eGFR, which is a test that shows how well your kidneys are filtering.
Other assessments will include checking for any signs of kidney transplant rejection, changes in blood pressure, and any potential side effects from the medication.
Step 5
End of study
The study is expected to last until April 2027. At the end of the study, the results will be analyzed to determine the safety and effectiveness of the medication.
You will be informed about the findings and any implications for your health and treatment.

Who can join the trial?

7 criteria

Must provide written informed consent, which means you agree to participate after being informed about the study.
Must be a male or female who is at least 18 years old.
Must have received a kidney transplant and not have diabetes.
Must be more than 6 months after the kidney transplant surgery.
Must have a kidney function test result, called eGFR, greater than 25 ml/min/1.73m² within the last 3 months before joining the study. eGFR is a test that measures how well your kidneys are working.
Must be taking a medication called Tacrolimus as part of your treatment to prevent organ rejection.
If you are a woman who can have children, you must have a negative pregnancy test (plasma hCG test) and agree to use contraception during the study.

Who cannot join the trial?

8 criteria

Patients who have received a kidney transplant cannot participate.
Patients with diabetes are not eligible. Diabetes is a condition where the body has trouble managing blood sugar levels.
Patients under the age of 18 or over the age of 65 are not eligible.
Pregnant or breastfeeding women cannot participate.
Patients with a history of severe allergic reactions to the study medication are excluded.
Patients with uncontrolled high blood pressure are not eligible. High blood pressure is when the force of the blood against the artery walls is too high.
Patients with severe liver disease cannot participate. The liver is an organ that helps process food and clean the blood.
Patients who are currently participating in another clinical trial are not eligible.

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Verified sites

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Aarhus University Hospital
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Aarhus, Denmark
Odense University Hospital
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Odense, Denmark
Region Midtjylland
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Aarhus, Denmark

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Investigated drugs

SGLT2i is a type of medication that helps the kidneys remove excess sugar from the body through urine. In this clinical trial, it is being tested to see if it can help improve kidney function in people who have received a kidney transplant but do not have diabetes. The goal is to determine if this medication can be safely used alongside standard treatments to support the health of the transplanted kidney.

Dapagliflozin

What is already known about the treatment

SGLT2i – This medication is taken orally and is being studied for its effects on kidney function in people who have received a kidney transplant but do not have diabetes. It is currently being evaluated in clinical trials to determine its safety and effectiveness compared to a placebo. The main goal is to see if it can help maintain kidney function in these patients. SGLT2i works by blocking a protein in the kidneys that helps reabsorb glucose, which can have protective effects on kidney health. It belongs to a class of drugs known as sodium-glucose co-transporter 2 inhibitors.

Investigated diseases

Post Transplant Diabetes Mellitus – This condition occurs when a person develops diabetes after receiving an organ transplant, such as a kidney. It is characterized by high blood sugar levels due to the body's inability to produce or use insulin effectively. The progression involves the gradual increase in blood glucose levels, which can lead to symptoms like increased thirst, frequent urination, and fatigue. Over time, if not managed, it can cause complications affecting the heart, nerves, and kidneys. The condition is influenced by factors such as the type of immunosuppressive medication used, weight gain, and family history of diabetes. Regular monitoring of blood sugar levels is crucial to manage this condition effectively.