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Study on the Effects of Finerenone, Dapagliflozin, and Ambrisentan in Patients with Chronic Kidney Disease

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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 studying the effects of a treatment approach for patients with chronic kidney disease. The study will involve the use of medications including finerenone (also known by its code name BAY 94-8862), dapagliflozin, and ambrisentan. These medications are taken orally and are being tested to see how they affect a condition called albuminuria, which is the presence of a protein called albumin in the urine, often a sign of kidney damage.

The purpose of the study is to compare a new treatment approach guided by certain biomarkers, which are substances in the body that can indicate how well the kidneys are functioning, against the standard care currently provided to patients. The study will last for a period of 64 weeks, during which participants will receive one of the treatments and have regular check-ups to monitor their kidney health and the levels of albumin in their urine. The study aims to see if the new approach can better manage albuminuria compared to the usual care.

Participants will be monitored for changes in their kidney function over time, specifically looking at how their estimated glomerular filtration rate (eGFR), a measure of kidney function, changes from the start of the study to the end. Additionally, the study will develop a communication tool to help patients and healthcare professionals understand how to use the biomarker-guided treatment approach. The study is expected to conclude by June 2026.

The research process

The trial runs in 5 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, eligibility is confirmed based on criteria such as age between 18 and 75 years, specific kidney function levels, and current medication use.
Participants must be on a stable dose of an ACE inhibitor or ARB for at least four weeks before starting the trial.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline measurements, including urine tests to measure albumin levels and kidney function tests.
Step 3
Medication administration
Participants receive medications including finerenone, dapagliflozin, and ambrisentan, all taken orally.
The dosage and frequency of these medications are determined by the study protocol and are administered throughout the trial duration.
Step 4
Ongoing monitoring
Regular monitoring occurs to track changes in albumin levels and kidney function over time.
Participants attend scheduled visits for assessments at various intervals, including weeks 16, 36, 64, and 66.
Step 5
Final assessment
At the end of the study, a final assessment is conducted to compare changes in albumin levels and kidney function from the start of the trial.
The study aims to develop a communication tool to guide future treatment based on biomarker responses.

Who can join the trial?

5 criteria

Age must be between 18 and 75 years old.
Have an eGFR (estimated glomerular filtration rate) of at least 25 mL/min/1.73m². This is a measure of how well your kidneys are working.
Have a UACR (urine albumin-to-creatinine ratio) greater than 100 mg/g in two consecutive first-morning urine samples. If your UACR is between 80-100 mg/g, it is acceptable if past measurements were above 100 mg/g and there is no new treatment explaining the lower value. UACR is a test that checks for protein in your urine, which can indicate kidney problems.
Must be taking the highest dose you can tolerate of an ACE inhibitor or ARB (angiotensin receptor blocker) for at least four weeks before joining the study. These are medications that help manage blood pressure and protect the kidneys.
Must be able to communicate with the study staff and understand and sign the informed consent, which is a document explaining the study and your rights as a participant.

Who cannot join the trial?

5 criteria

Patients with **chronic kidney disease** cannot participate. This is a long-term condition where the kidneys do not work as well as they should.
Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
Patients who do not fit into the specific clinical trial groups cannot participate. These groups are defined by the study.
Both **male** and **female** patients are considered, but certain criteria may exclude some individuals.
Patients who are part of a **vulnerable population** are not included. This means people who might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
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Naples, Italy
IRCCS Azienda Ospedaliero Universitaria - Policlinico di Sant'Orsola
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Bologna, Italy
University Medical Center Hamburg-Eppendorf
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Hamburg, Germany

Trial locations

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Investigated drugs

Clusterin
is a protein that is being studied for its potential role in managing chronic kidney disease. In this trial, researchers are investigating how clusterin levels in urine might help guide treatment decisions to improve kidney function.
EGF
, or Epidermal Growth Factor, is another protein being examined in this study. It is being used to see if its presence in urine can help tailor treatments for patients with chronic kidney disease, potentially leading to better management of the condition.

What is already known about the treatment

Clusterin
Clusterin is administered as a biomarker test, typically through a urine sample, to help guide treatment decisions in patients with chronic kidney disease. It is currently being studied in clinical trials to validate its effectiveness in managing this condition. The main therapeutic indication is to assist in the treatment of chronic kidney disease by monitoring albuminuria levels. At the molecular level, clusterin acts as a chaperone protein, helping to stabilize other proteins and prevent their aggregation, which can be beneficial in reducing kidney damage. It is classified as a diagnostic biomarker rather than a traditional pharmacological agent.
Epidermal Growth Factor (EGF)
EGF is also administered as a biomarker test through urine samples in the context of chronic kidney disease management. It is under investigation in clinical trials to determine its role in guiding treatment based on biomarker responses. The primary therapeutic indication is to aid in the management of chronic kidney disease by evaluating its impact on albuminuria. EGF works at the molecular level by binding to its receptor, EGFR, on cell surfaces, promoting cell growth and repair, which may help in kidney tissue regeneration. Like clusterin, EGF is classified as a diagnostic biomarker.

Investigated diseases

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 changes in urination. Over time, the reduced kidney function can affect other body systems, including the heart and bones. The progression of the disease can vary among individuals, with some experiencing a slow decline in kidney function while others may progress more rapidly. Regular monitoring and lifestyle adjustments are often necessary to manage the condition and slow its progression.