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Study of semaglutide and finerenone for kidney and blood vessel protection in adults with chronic kidney disease, with or without diabetes

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with Chronic Kidney Disease (CKD), a long-term condition where the kidneys do not function properly. The study will test two medications: semaglutide, which is given as an injection, and finerenone, which comes as tablets. These medications will be tested both individually and in combination to see how well they protect the kidneys and blood vessels in people with CKD, including those who have diabetes and those who do not.

The main purpose is to understand how these medications can help protect kidney function and improve blood vessel health in people with CKD. During the study, participants will receive different doses of the medications: semaglutide injections ranging from 0.25 mg to 1 mg, and finerenone tablets in either 10 mg or 20 mg strengths.

The study will measure how well the medications work by looking at changes in the amount of protein in participants' urine, which is an important indicator of kidney health. The treatment will involve two separate periods: first, participants will receive either semaglutide or no treatment, and then in the second period, all participants will receive finerenone in addition to their existing treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment period
You will be assigned to receive either semaglutide (Ozempic) injections or no treatment for the first phase of the study.
If assigned to semaglutide, you will receive injections starting with 0.25 mg, progressing to 0.5 mg, and potentially up to 1 mg using pre-filled pens.
This phase lasts for 20 weeks.
Step 2
Combined treatment period
Following the initial period, you will begin taking finerenone (Kerendia) tablets in addition to your current treatment.
Finerenone will be provided as film-coated tablets in either 10 mg or 20 mg doses.
This combined treatment phase continues until the end of the study.
Step 3
Monitoring and measurements
Throughout the study, your kidney function will be monitored through urine tests.
You will need to provide morning urine samples at specific times during the study.
The main measurement will be the urine albumin-to-creatinine ratio, which shows how well your kidneys are functioning.
Step 4
Study completion
The study will evaluate how the medications affect your kidney function, both individually and in combination.
Final measurements will be taken to compare with your initial results.
The total duration of participation will continue until the study ends in September 2028.

Who can join the trial?

9 criteria

Must be at least 18 years old
Must have a kidney function test result (eGFR) greater than 20 ml/min/1.73 m2 (this test measures how well your kidneys are filtering waste)
Must have specific levels of protein in urine (UACR), with different requirements depending on current medications:
- If taking both SGLT2 inhibitors and ACE inhibitors/ARBs: UACR must be above 30 mg/g
- If not taking either medication: UACR must be above 100 mg/g
- If taking only one of these medications: UACR must be above 50 mg/g
- Must meet specific group requirements:
  - Group 1: Must have Type 2 diabetes with blood sugar control test (HbA1c) less than 86 mmol/mol
  - Group 2: Must have a body mass index (BMI) between 21 and 30 kg/m2
  - Both men and women can participate
  - Must be able to provide written informed consent

Who cannot join the trial?

15 criteria

Patients under 18 years of age
Patients over 75 years of age
Individuals with a known allergy or hypersensitivity to semaglutide or finerenone (the study medications)
Pregnant or breastfeeding women
Patients with severe liver disease
Individuals receiving dialysis treatment
Patients who have had a kidney transplant
People with uncontrolled high blood pressure (hypertension)
Patients with severe heart conditions
Individuals participating in other clinical trials
Patients with a history of pancreatic inflammation (pancreatitis)
People with a personal or family history of a specific type of thyroid cancer called medullary thyroid carcinoma
Patients taking medications that could interact with the study drugs
Individuals with a history of severe allergic reactions
Patients unable to provide informed consent

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Region Midtjylland
Responsive
Aarhus, Denmark

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Investigated drugs

Semaglutide is a medication used to treat type 2 diabetes and obesity. It works by helping control blood sugar levels and can help reduce appetite and food intake. In this trial, it's being studied for its potential protective effects on the kidneys. Finerenone is a medication that belongs to a class of drugs called mineralocorticoid receptor antagonists. It helps protect the kidneys and heart by reducing inflammation and scarring in kidney tissue. The medication works by blocking certain hormones that can damage the kidneys over time. The trial studies these medications both individually and in combination to see how they might work together to protect the kidneys and blood vessels in people who have chronic kidney disease (CKD), whether or not they have diabetes.

What is already known about the treatment

Semaglutide
An injectable medication belonging to the GLP-1 receptor agonist class that is administered once weekly via subcutaneous injection. This medication works by mimicking the natural hormone GLP-1, which helps regulate blood sugar levels and reduces appetite by acting on receptors in the pancreas and brain. It is primarily used for treating type 2 diabetes and chronic kidney disease, while also providing cardiovascular benefits and weight management effects through its complex molecular mechanism that involves multiple organ systems.
Finerenone
A non-steroidal mineralocorticoid receptor antagonist that is taken orally in tablet form. This medication works by selectively blocking mineralocorticoid receptors, which helps reduce inflammation and fibrosis in kidney and heart tissues. It is specifically indicated for treating chronic kidney disease in patients with type 2 diabetes, helping to slow the progression of kidney disease and reduce the risk of cardiovascular complications through its targeted action on the mineralocorticoid receptor system.

Investigated diseases

Chronic Kidney Disease – A condition where kidneys gradually lose their ability to filter waste and excess fluid from the blood. The disease typically develops slowly over months or years as the kidneys become increasingly damaged. It can be caused by various underlying conditions, including diabetes and high blood pressure. The main feature is the kidneys' decreased ability to clean the blood effectively, which leads to the buildup of waste products in the body. As the condition progresses, it can affect many body systems and lead to changes in urination patterns, swelling in legs and ankles, and changes in blood pressure.