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Study on Reducing Protein in Urine for Patients with Chronic Kidney Disease Using Finerenone and Semaglutide

Verified siteRegistered drugNo placebo
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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 improving treatment for patients with Chronic Kidney Disease (CKD). The study will explore the effects of two medications: finerenone and semaglutide. Finerenone is a medication that helps reduce the amount of protein in the urine, which is a common issue in CKD. Semaglutide, also known by its code name NNC0113-0217, is a medication that helps control blood sugar levels and may also have benefits for kidney health.

The purpose of the study is to determine if either finerenone or semaglutide can reduce the amount of protein in the urine by at least 30% in a significant number of patients. Participants will be given either finerenone, semaglutide, or a placebo to see which treatment works best for them. The study will last for several months, with regular check-ups to monitor the effects of the medication on kidney function and overall health.

Throughout the study, participants will take their assigned medication orally in the form of tablets. The study aims to find the best treatment option for each individual, potentially leading to better management of Chronic Kidney Disease. The results will help doctors understand how these medications can be used to improve the health of people with CKD.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be informed about the trial's purpose, which is to improve albuminuria in patients with chronic kidney disease using finerenone and semaglutide.

    The patient will be required to sign an informed consent form to confirm their willingness to participate.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility, which includes checking age, urinary albumin to creatinine ratio, estimated glomerular filtration rate (eGFR), and HbA1c levels.

    The patient must be on a stable dose of an ACE inhibitor or ARB and an SGLT2 inhibitor for at least 4 weeks if tolerated.

  3. Step 3

    Medication administration

    The patient will be assigned to receive either Rybelsus (semaglutide) or Kerendia (finerenone) based on individual suitability.

    Rybelsus is available in 3 mg, 7 mg, and 14 mg tablets, and is taken orally.

    Kerendia is available in 20 mg film-coated tablets, and is also taken orally.

  4. Step 4

    Monitoring and follow-up

    The patient will be monitored regularly to assess the percentage change from baseline in urinary albumin to creatinine ratio (UACR).

    The patient will be required to report any missed urine collections, especially those conducted at home.

  5. Step 5

    Completion of the trial

    The trial is expected to conclude by December 31, 2025.

    Upon completion, the patient will be informed of the results and any further steps if necessary.

Who can join the trial?

7 criteria

  • Must be **18 years or older**.
  • Have a **urinary albumin to creatinine ratio** between **100 mg/g and 3500 mg/g**. This is a test that measures the amount of a protein called albumin in your urine compared to a waste product called creatinine.
  • Have an **eGFR** between **25 and 90 mL/min/1.73m²**. eGFR is a test that checks how well your kidneys are working.
  • Have an **HbA1c** level between **5.7% and less than 11%**. HbA1c is a blood test that shows your average blood sugar levels over the past 2 to 3 months.
  • Be on a stable dose of an **ACEi/ARB** for at least **4 weeks** if you can tolerate it. These are types of medications used to treat high blood pressure and kidney problems.
  • Be on a stable dose of an **SGLT2 inhibitor** for at least **4 weeks** if you can tolerate it. This is a type of medication used to lower blood sugar levels.
  • Willing to **sign an informed consent**. This means you agree to participate in the study after being told all the important details.

Who cannot join the trial?

3 criteria

  • Patients who do not have Chronic Kidney Disease cannot participate. This is a condition where the kidneys are damaged and cannot filter blood as well as they should.
  • Patients who are not within the specified age range cannot participate. The age range for this study is from 18 to 64 years old.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care, like those with certain disabilities or those who are unable to make decisions for themselves.
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Investigated drugs

  • Finerenone

    is a medication used in this trial to help reduce albuminuria, which is a condition where there is too much protein in the urine. This medication is being tested to see if it can effectively lower the levels of albumin in patients with chronic kidney disease (CKD) when chosen as the best option for the individual patient.

  • Semaglutide

    is another medication involved in the trial. It is used to help lower albuminuria in patients with chronic kidney disease. The trial aims to determine if semaglutide can achieve a significant reduction in albumin levels when it is selected as the most suitable treatment for a patient.

What is already known about the treatment

  • Finerenone

    Finerenone is administered orally in tablet form. It is currently being studied for its effectiveness in treating chronic kidney disease (CKD) by reducing albuminuria, a condition where protein is present in urine. The medication works by blocking mineralocorticoid receptors, which helps reduce inflammation and fibrosis in the kidneys. It is classified as a mineralocorticoid receptor antagonist (MRA).

  • Semaglutide

    Semaglutide is available as an injection and is administered subcutaneously. It is being researched for its potential to lower albuminuria in patients with chronic kidney disease. Semaglutide functions by mimicking the hormone GLP-1, which increases insulin secretion and reduces glucagon levels, thereby improving kidney function. It belongs to the class of glucagon-like peptide-1 receptor agonists (GLP-1 RAs).

Investigated diseases

Chronic Kidney Disease – This condition involves the 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 the disease can vary, with some people experiencing a slow decline in kidney function, while others may have a more rapid deterioration. Chronic kidney disease can eventually lead to kidney failure if not managed properly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506434-69-00Protocol code17456Estimated enrolment36 patientsSponsorUniversitair Medisch Centrum Groningen

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