A study testing finerenone compared to placebo in patients with chronic kidney disease who are not taking renin-angiotensin-system inhibitors

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What is this study about?

This study involves people with chronic kidney disease who are not currently taking certain blood pressure medications that affect the kidneys. Chronic kidney disease is a condition where the kidneys gradually lose their ability to filter waste and excess fluid from the blood. The study will compare the effects of finerenone, which is also called BAY 94-8862, with placebo. Finerenone is a medication given as a film-coated tablet that is taken by mouth.

The purpose of the study is to find out if finerenone is better than placebo in reducing the amount of protein in the urine over six months. Protein in the urine is a sign that the kidneys are not working properly. The study will also look at the safety of finerenone by checking for side effects and monitoring potassium levels in the blood, as high potassium can be a concern with this type of medication.

Participants in this study will be randomly assigned to receive either finerenone or placebo for a treatment period that can last up to 175 days. During the study, participants will have regular check-ups where doctors will measure the protein levels in their urine and monitor their overall health. The study is designed to be double-blind, which means that neither the participants nor the doctors will know who is receiving finerenone and who is receiving placebo until the study is completed.

1 Randomization and treatment assignment

After joining the study, you will be randomly assigned to one of two treatment groups. This process is called randomization and works like flipping a coin to determine which group you will be in.

You will receive either finerenone (the medication being tested) or placebo (an inactive substance that looks like the medication but contains no active ingredient).

Neither you nor your doctor will know which treatment you are receiving. This is called a double-blind study and helps ensure the results are accurate.

2 Taking the study medication

You will take the assigned medication by mouth in the form of film-coated tablets.

The study will evaluate the effects of finerenone compared to placebo over a period of 6 months.

Your doctor will provide specific instructions on how often to take the medication and what dose to use.

3 Regular monitoring visits

Throughout the study, you will attend regular visits at the study site.

During these visits, your kidney function will be monitored by measuring eGFR (a calculation that shows how well your kidneys are filtering waste) and UACR (a urine test that measures the amount of protein in your urine, which indicates kidney health).

Your potassium level will be checked regularly through blood tests to ensure it stays within a safe range.

The study team will monitor for any side effects or health changes that may occur during treatment.

4 Assessment at 6 months

At the 6-month mark, the main assessment will be performed to measure changes in your UACR (urine protein levels) compared to the beginning of the study.

This measurement helps determine whether the medication is effective in reducing protein in your urine, which is a sign of improved kidney function.

5 Safety monitoring throughout the study

Throughout the entire study period, any side effects or health problems you experience will be recorded and evaluated.

Special attention will be given to monitoring for hyperkalemia, which means having too much potassium in your blood.

Any serious health events will be carefully documented and assessed by the study team.

6 Completion of the study

The study is expected to continue until the end of 2027.

After completing your participation, final assessments will be performed to evaluate your overall health and the effects of the treatment you received.

Who Can Join the Study?

You must be at least 18 years old or the legal age to give consent in your area at the time of signing the consent form.
Your potassium level (a mineral in your blood) must be 5.0 or lower at the screening visit.
You must have a medical diagnosis of chronic kidney disease (long-term kidney problems) and meet both of these requirements: Your eGFR (a blood test that shows how well your kidneys are filtering waste) must be between 25 and 120; and Your UACR (a urine test that measures protein in your urine) must be between 100 and 5000, and you must have had high levels of protein in your urine documented in your medical records at least 3 months before the screening visit.
You must not be currently taking or have taken in the past 8 weeks any medicines called RAS inhibitors (medications that help control blood pressure and protect the kidneys, such as ACE inhibitors, ARBs, or Renin inhibitors like Aliskiren).
You can be male or female.
You must be able to understand and sign the consent form, and be willing to follow all the requirements of the study.

Who Cannot Join the Study?

Pregnant women or women who are breastfeeding cannot participate in this study
People who are allergic (have a bad reaction) to finerenone or any ingredient in the study medicine
People with severe kidney problems who need dialysis (a treatment that cleans the blood when kidneys cannot do this job)
People with very high levels of potassium (a mineral in your blood) in their blood
People who are already taking RAS inhibitors (medicines that help control blood pressure and protect the kidneys)
People with severe liver disease (serious problems with the organ that cleans toxins from your body)
People who have had a heart attack (when blood flow to the heart is blocked) or stroke (when blood flow to the brain is blocked) in the last month
People with heart failure (when the heart cannot pump blood well enough) that is not stable or controlled
People taking certain medicines that can interact badly with the study medicine, including some antifungal medicines (medicines that treat fungal infections) and some medicines for HIV (a virus that affects the immune system)
People who cannot follow the study requirements or attend regular visits
People participating in another clinical trial at the same time

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario De Getafe	Getafe	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario Dr Peset Aleixandre	Valencia	Spain
Hvosndfp Ujwhxpvjgahoz Dn Ll Pwfcojgw	Madrid	Spain
Hsgbyskp Ujplaeffnecus Hijcqmxz Tyljs y Pzcxin Ipwklauc Ciqvgo dexrtqqxkqolgbjnj (qaer	Badalona	Spain
Hketaepg Vxom dykwhnnr	Barcelona	Spain
Hiravdbx Uxioawvzepwqa db A Cztcgz	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.01.2026

Trial locations

Investigated drugs:

Finerenone

Finerenone is a medication being tested in this study for people with chronic kidney disease. It works by blocking certain hormones that can cause damage to the kidneys. The researchers want to see if this medication can help reduce protein levels in the urine, which is a sign of kidney damage, compared to a placebo (a dummy pill with no active medication).

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. The disease develops slowly over months or years, often without noticeable symptoms in the early stages. As the condition progresses, waste products build up in the body, leading to various health problems. The kidneys become less effective at maintaining the balance of minerals and fluids in the body. Over time, the damage to the kidneys becomes permanent and can worsen if left unmanaged. The disease typically advances through five stages, with each stage representing a further decline in kidney function.

Trial ID:

2025-523075-32-00

Protocol code:

22817

Trial Phase:

Therapeutic confirmatory (Phase III)

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A study testing finerenone compared to placebo in patients with chronic kidney disease who are not taking renin-angiotensin-system inhibitors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?