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Study on Dapagliflozin, Finerenone, and Semaglutide for Treating Chronic Kidney Disease in 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 finding the best treatment for patients with Chronic Kidney Disease (CKD). The study will use a biomarker-targeted approach, which means it will look at specific biological markers in the body to help decide the best treatment. The medications being studied include Dapagliflozin, Finerenone (also known as BAY 94-8862), and Semaglutide (also known as NNC0113-0217). These medications are being tested to see how they affect the progression of CKD.

The purpose of the study is to compare the effects of this targeted treatment approach with the standard care currently used for CKD. Participants in the study will receive one of the medications or a placebo. The study will last for about two years, during which time participants will take the medication and have regular check-ups to monitor their kidney function and overall health. The main focus will be on how the treatment affects the rate of change in kidney function over time.

Throughout the study, changes in kidney function will be measured by looking at the estimated glomerular filtration rate (eGFR), which is a test that shows how well the kidneys are working. Other aspects, such as changes in protein levels in the urine and a special score called the KidneyIntelX score, will also be monitored. The study aims to provide valuable information that could lead to better treatment options for people with CKD.

The research process

The trial runs in 6 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 asked to sign an informed consent form. This document confirms that you understand the study and agree to participate.
You will need to meet certain criteria, such as being between 18 and 75 years old and having specific levels of protein in your urine, to be eligible for the study.
Step 2
Initial assessment
An initial assessment will be conducted to gather baseline information about your health. This may include blood tests, urine tests, and other evaluations to understand your kidney function.
Step 3
Treatment phase
During the treatment phase, you will receive medications that are part of the study. These include dapagliflozin propanediol and finerenone, which are taken orally, and semaglutide, which is administered through a subcutaneous injection.
The exact dosage and frequency of these medications will be determined by the study team and will be explained to you in detail.
Step 4
Ongoing monitoring
Throughout the study, your health will be monitored regularly. This includes scheduled visits to the study site for tests and assessments to track your kidney function and overall health.
You will be required to provide urine samples and undergo blood tests at specified intervals.
Step 5
End of treatment
The treatment phase will continue until week 104. At this point, the study team will evaluate the changes in your kidney function and other health markers.
You will be asked to complete final assessments to gather data on the effects of the treatment.
Step 6
Follow-up
After the treatment phase, there will be a follow-up period until week 112. This is to ensure your health is stable and to collect additional data on the long-term effects of the treatment.
You may be asked to return for additional assessments during this time.

Who can join the trial?

4 criteria

Age must be between 18 and 75 years old.
Have a UACR (urine albumin-to-creatinine ratio) between 100-5000 mg/g in two morning urine samples. A UACR of 80-100 mg/g is acceptable if past measurements were above 100 mg/g and there is no new treatment causing the change.
Be on a stable treatment with the highest dose you can tolerate of an ACE inhibitor (angiotensin-converting enzyme inhibitor) or ARB (angiotensin receptor blocker) for at least four weeks before starting the study. This is not required if you cannot take these medications.
Be able to talk with the study staff, understand the study, and sign the consent form.

Who cannot join the trial?

3 criteria

Patients with **chronic kidney disease** cannot participate.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.

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Verified sites

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Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Naples, Italy
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University Of Skane
Malmo, Sweden

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Investigated drugs

MSC-001 is a new experimental drug being tested in this clinical trial. It is designed to help improve kidney function in patients with chronic kidney disease. The medication works by targeting specific biomarkers in the body that are linked to the progression of kidney disease. By focusing on these biomarkers, MSC-001 aims to slow down the decline in kidney function, which is measured by a test called eGFR. This test checks how well the kidneys are filtering waste from the blood. The goal of using MSC-001 is to provide a more personalized treatment option that could be more effective than the standard treatments currently available.

What is already known about the treatment

Biomarker-targeted treatment – This medication is administered to patients with chronic kidney disease, aiming to improve kidney function by targeting specific biomarkers. Currently, it is being studied in clinical trials to determine its effectiveness compared to standard treatments. The main therapeutic indication is to slow down the decline in kidney function, as measured by the chronic eGFR slope. At the molecular level, the medication works by interacting with specific proteins or pathways involved in kidney disease progression, helping to preserve kidney function. It falls under the pharmacological classification of targeted therapies, which are designed to act on specific biological markers associated with a disease.

Investigated diseases

Chronic kidney disease – Chronic kidney disease is a long-term condition characterized by a gradual loss of kidney function over time. The kidneys become less effective at filtering waste and excess fluids from the blood, which can lead to a buildup of harmful substances in the body. As the disease progresses, individuals may experience symptoms such as fatigue, swelling in the legs and ankles, and changes in urination patterns. The progression of chronic kidney disease is typically measured by the decline in the glomerular filtration rate (GFR), which indicates how well the kidneys are filtering blood. Over time, the disease can lead to complications such as high blood pressure, anemia, and bone disease. The rate of progression can vary, and it is often influenced by underlying conditions such as diabetes and hypertension.