Study on the Effects of Dapagliflozin on Blood Vessel Health in Patients with Chronic Kidney Disease

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What is this study about?

This clinical trial is focused on studying the effects of the medication dapagliflozin on patients with chronic kidney disease. Chronic kidney disease is a condition where the kidneys are damaged and cannot filter blood as well as they should. The study aims to see if dapagliflozin can improve the function of blood vessels in these patients. Dapagliflozin is a medication that is usually used to help control blood sugar levels in people with diabetes, but this study is exploring its potential benefits for kidney disease patients.

Participants in the study will be randomly assigned to receive either dapagliflozin or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for 12 weeks, during which time the effects of the treatment on blood vessel function will be monitored. This will involve measuring how well the blood vessels can expand in response to increased blood flow, which is an important aspect of vascular health.

The goal of the study is to determine if dapagliflozin can improve the health of blood vessels in people with chronic kidney disease. This could potentially lead to better management of the disease and improved overall health outcomes for patients. The study will also look at other factors, such as changes in certain substances in the blood that are related to inflammation and blood vessel function, to gain a better understanding of how dapagliflozin might benefit these patients.

1 joining the study

Upon joining the study, the patient must have read and understood the information letter and signed the informed consent form.

Eligibility includes being a chronic kidney disease patient with specific kidney function levels, being 18 years or older, and having been on a stable dose of an ACE inhibitor or ARB for at least 12 weeks, or being unable to take these medications.

2 initial assessment

An initial assessment is conducted to confirm eligibility and establish baseline measurements. This includes a blood test for women of childbearing potential to confirm a negative pregnancy status.

3 medication administration

The patient will receive either dapagliflozin or a placebo. Dapagliflozin is administered orally in the form of film-coated tablets.

The treatment duration is 12 weeks, during which the patient will take the medication as prescribed.

4 monitoring and follow-up

Throughout the 12-week period, the patient will be monitored for changes in vascular function, including the dilation of arteries in response to increased blood flow.

Additional assessments will measure changes in blood components and heart function.

5 final evaluation

At the end of the 12-week treatment period, a final evaluation will be conducted to assess the impact of the treatment on vascular function and other health indicators.

Who Can Join the Study?

Must have chronic kidney disease with a specific kidney function level (eGFR between 25 and 60 mL/min/1.73m²).
Must be 18 years or older.
Must be taking a stable dose of a medication called an ACE inhibitor or ARB for at least 12 weeks before the study starts, or have a documented reason for not being able to take these medications.
Must have read and understood the information about the study and signed the Informed Consent Form.
For women who can have children:
- Must use effective birth control for at least 4 weeks before starting the study and during the study.
- Must have a negative blood pregnancy test.
Women who are surgically sterile or postmenopausal can participate. Postmenopausal means not having a period for at least 12 months without medical reasons.
Must be able to follow the study rules, as judged by the study doctor.
Must have health insurance or be part of a social security system.

Who Cannot Join the Study?

Patients who do not have chronic kidney disease cannot participate. This means the study is only for those who have long-term problems with their kidneys.
Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
Patients who are not able to give informed consent cannot participate. This means they must understand the study and agree to take part.
Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
Patients with other serious health conditions that might interfere with the study cannot participate. This is to make sure the results are accurate and not affected by other illnesses.
Patients who are currently participating in another clinical trial cannot participate. This is to avoid any interference between different studies.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire Rouen	Rouen	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	18.10.2022

Trial locations

Investigated drugs:

Dapagliflozin

Dapagliflozin is a medication used in this clinical trial to assess its impact on vascular function in patients with chronic kidney disease. The main goal is to see if a 12-week treatment with dapagliflozin can improve the function of blood vessels, specifically how well they can dilate or widen in response to increased blood flow. This is important for understanding how the medication might help improve circulation and overall vascular health in these patients.

Investigated diseases:

Chronic kidney disease

Chronic Kidney Disease – Chronic kidney disease is a long-term condition where the kidneys gradually lose their ability to filter waste and excess fluids from the blood. This disease progresses through stages, starting with mild damage and potentially advancing to severe kidney failure. As the kidneys become less effective, waste products and fluids can build up in the body, leading to symptoms such as fatigue, swelling, and high blood pressure. Over time, the reduced kidney function can affect other organs and systems, including the heart and blood vessels. The progression of the disease can vary among individuals, with some experiencing a slow decline in kidney function while others may progress more rapidly.

Trial ID:

2024-514887-14-00

Protocol code:

2021/0188/HP

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Dapagliflozin on Blood Vessel Health in Patients with Chronic Kidney Disease

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