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Study on Dapagliflozin and Lifestyle Changes for Patients with Early Chronic Kidney Disease and Prediabetes

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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 Dapagliflozin on individuals with prediabetes and early stages of chronic kidney disease (CKD). Prediabetes is a condition where blood sugar levels are higher than normal but not high enough to be classified as diabetes. Chronic kidney disease is a long-term condition where the kidneys do not work as well as they should. The study will compare the effects of Dapagliflozin, which is taken as a film-coated tablet, with a placebo. The purpose of the study is to see if Dapagliflozin, along with lifestyle changes, can improve kidney health in these patients.

Participants in the study will be randomly assigned to receive either Dapagliflozin or a placebo, in addition to lifestyle counseling, for a period of one year. Lifestyle counseling involves guidance on diet and exercise to help manage health conditions. The study aims to determine if this combination can reduce kidney damage, as indicated by a decrease in a specific marker called albuminuria, which is a sign of kidney damage. Albuminuria is the presence of a protein called albumin in the urine, which can be an early sign of kidney disease.

The trial will involve regular check-ups and monitoring to assess the health of the participants and the effectiveness of the treatment. The study is designed to provide valuable information on whether adding Dapagliflozin to lifestyle changes can help prevent complications in people with prediabetes and early chronic kidney disease. Participants will be closely monitored throughout the study to ensure their safety and well-being.

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
Initial visit
Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on specific criteria such as age, risk for diabetes, and early signs of kidney disease.
A blood test is conducted to ensure thyroid levels are normal and to confirm a negative pregnancy test for premenopausal women.
Step 2
Randomization
Participants are randomly assigned to one of two groups: one receiving the dapagliflozin medication and the other receiving a placebo. Both groups receive lifestyle counseling.
Step 3
Medication administration
If assigned to the dapagliflozin group, take one 10 mg tablet daily by mouth. If assigned to the placebo group, take one placebo tablet daily by mouth.
The medication or placebo is taken for a duration of one year.
Step 4
Regular follow-up visits
Attend regular follow-up visits as scheduled by the study team. These visits are important for monitoring health and progress.
During these visits, various assessments are conducted to evaluate kidney function and overall health.
Step 5
Final assessment
At the end of the one-year period, a final assessment is conducted to evaluate the impact of the treatment on kidney health.
The results are compared between the group receiving dapagliflozin and the group receiving the placebo.

Who can join the trial?

12 criteria

Men, women, or intersex individuals aged between 35 and 75 years.
Patients at high risk for diabetes with early signs of kidney disease. This includes a specific range of a test called urinary albumin-to-creatinine ratio (uACR) between 30 mg/g and 300 mg/g, and early stages of chronic kidney disease (CKD stage G1A2 or G2A2).
Patients with prediabetes, which means having slightly higher than normal blood sugar levels. This can be shown by one of the following: fasting glucose (FG) over 100 mg/dL, HbA1c over 5.6%, or a 2-hour oral glucose tolerance test (OGTT) result over 140 mg/dL.
A Body Mass Index (BMI) of 20 kg/m² or higher. BMI is a measure of body fat based on height and weight.
Thyroid-stimulating hormone (TSH) levels must be within the normal range. TSH is a hormone that controls the thyroid gland.
Ability to understand and follow instructions related to the study.
For women who have not yet gone through menopause, a negative pregnancy test is required.
If receiving thyroid replacement therapy, patients must have been on a stable treatment plan for at least 3 months before the study starts.
If taking antihypertensive medication like mineralocorticoid receptor antagonists, patients must have been on a stable treatment plan for at least 6 weeks before the study starts. Antihypertensive medications are used to treat high blood pressure.
If taking other antihypertensive medications such as ACE inhibitors, AT1 receptor antagonists, thiazides, or loop diuretics, patients must have been on a stable treatment plan for at least 2 weeks before the study starts.
Must understand and voluntarily sign a consent form before any study-related procedures.
Patients will not be included if the study doctor believes participation could pose an unacceptable risk to their safety or well-being.

Who cannot join the trial?

4 criteria

Patients with **advanced stages** of chronic kidney disease cannot participate. This means if your kidney disease is more severe than the early stages, you are not eligible.
Patients who do not have **prediabetes** are not eligible. Prediabetes is a condition where blood sugar levels are higher than normal but not high enough to be classified as diabetes.
Patients who are not within the specified **age range** cannot participate. The study is looking for participants within certain age groups.
Patients who are part of a **vulnerable population** may not be eligible. This includes groups who might need special protection in research studies.

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Verified sites

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

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Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
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Deutsche Diabetes Forschungsgesellschaft e.V.
Duesseldorf, Germany
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Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Munich, Germany

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Investigated drugs

SGLT2 Inhibitor is a type of medication that helps lower blood sugar levels by preventing the kidneys from reabsorbing sugar back into the blood. Instead, the sugar is removed from the body through urine. In this clinical trial, the SGLT2 inhibitor is being tested to see if it can help improve kidney health in people with prediabetes when combined with lifestyle changes like diet and exercise.

Dapagliflozin

What is already known about the treatment

SGLT2 Inhibitor – This medication is taken orally and works by blocking a protein in the kidneys that helps reabsorb glucose back into the blood, leading to more glucose being excreted in the urine. It is currently being studied in clinical trials to see if it can help improve kidney damage in people with early-stage chronic kidney disease and prediabetes. The main therapeutic use being explored is its potential to reduce complications related to these conditions. SGLT2 inhibitors are classified as antidiabetic drugs, and they are being investigated for their benefits beyond blood sugar control.

Investigated diseases

Chronic Kidney Disease (CKD) Stage G1A2/G2A2
Chronic Kidney Disease is a condition characterized by a gradual loss of kidney function over time. In the early stages, such as G1A2 and G2A2, the kidneys may still function relatively well, but there is evidence of kidney damage, often indicated by the presence of albumin in the urine (albuminuria). As the disease progresses, the kidneys' ability to filter waste from the blood diminishes, leading to the accumulation of waste products in the body. This stage may not present significant symptoms, but it can be detected through laboratory tests. Over time, if the condition worsens, it can lead to more severe stages of kidney disease. Early detection and management are crucial to slow the progression of the disease.
Prediabetes
Prediabetes is a condition where blood sugar levels are higher than normal but not high enough to be classified as diabetes. It indicates an increased risk of developing type 2 diabetes. During this stage, the body begins to have trouble using insulin effectively, leading to elevated blood glucose levels. Prediabetes often has no clear symptoms, making it difficult to detect without blood tests. If left unaddressed, it can progress to type 2 diabetes, which involves more significant health complications. Lifestyle changes can play a critical role in managing blood sugar levels and preventing the progression to diabetes.