Study on the Effectiveness and Safety of Finerenone for Patients with Chronic Kidney Disease and Type 1 Diabetes

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What is this study about?

This clinical trial is focused on studying the effects of a treatment called finerenone on people who have a long-term decrease in their kidneys’ ability to work properly, known as chronic kidney disease, along with type 1 diabetes. The study aims to find out how well finerenone works and how safe it is when used in addition to the usual care for these conditions. Finerenone is taken as a film-coated tablet and is being compared to a placebo, which looks like the real medication but does not contain the active substance.

The purpose of the study is to see if finerenone can help reduce a specific measure related to kidney function over a period of six months. Participants in the study will be randomly assigned to receive either finerenone or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study. The study will take place over several months, and participants will continue to receive their standard care for chronic kidney disease and type 1 diabetes while participating in the trial.

Throughout the study, researchers will monitor participants for any changes in their kidney function and any side effects that may occur. The main focus will be on changes in a specific kidney-related measure, and researchers will also keep track of any adverse events, including any significant increases in potassium levels, which is a potential side effect of the treatment. The study is designed to provide valuable information about the potential benefits and safety of finerenone for people with chronic kidney disease and type 1 diabetes.

1 joining the study

Upon joining the study, you will be randomly assigned to receive either the study medication, finerenone, or a placebo. A placebo looks like the study medication but does not contain the active ingredient.

The study is designed to be double-blind, meaning neither you nor the study team will know which treatment you are receiving. This helps ensure the results are unbiased.

2 medication administration

You will take the assigned medication in the form of a film-coated tablet by mouth. The exact dosage and frequency will be provided by the study team.

The medication will be taken in addition to your standard care for chronic kidney disease and type 1 diabetes.

3 study duration

The study will last for approximately 6 months. During this time, you will continue to take the medication as instructed.

Regular check-ups will be scheduled to monitor your health and the effects of the medication.

4 health assessments

Throughout the study, your health will be closely monitored. This includes measuring your UACR (urinary albumin-to-creatinine ratio) to assess kidney function.

You will also be monitored for any side effects, including hyperkalaemia (high potassium levels in the blood).

5 end of study

At the end of the study, a final assessment will be conducted to evaluate the effects of the medication on your condition.

The study team will discuss the results with you and provide guidance on any further steps.

Who Can Join the Study?

Participant must be at least 18 years old at the time of signing the consent form.
Participants must have Type 1 Diabetes (T1D), which means they have been continuously treated with insulin, starting within one year from their diagnosis.
The HbA1c level, which is a measure of blood sugar control over the past 2-3 months, must be less than 10% at the screening. If the first test result is missing or invalid, one retest is allowed.
The level of potassium (K+) in the blood must be 4.8 mmol/L or lower at the screening.
Participants must have a clinical diagnosis of Chronic Kidney Disease (CKD) and meet both of these criteria:
- The eGFR (estimated Glomerular Filtration Rate), which measures kidney function, must be between 25 and 90 mL/min/1.73 m² at the screening.
- The UACR (Urine Albumin-to-Creatinine Ratio), which measures protein in the urine, must be between 200 mg/g and 5000 mg/g at the screening, based on the average of three measurements.
Participants must be on a stable treatment with either an ACEI (Angiotensin-converting enzyme inhibitor) or an ARB (Angiotensin receptor blocker) for at least four weeks before the screening, preferably without any change in dosage.

Who Cannot Join the Study?

Patients with any other serious medical condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a kidney transplant.
Patients who are currently participating in another clinical trial.
Patients with a history of severe allergic reactions to the study medication.
Patients with uncontrolled high blood pressure.
Patients with severe liver disease.
Patients with a history of drug or alcohol abuse.
Patients who are unable to follow the study procedures.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Sydvestjysk Sygehus	Esbjerg	Denmark
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo	Milan	Italy
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate	Chieti	Italy
Aalborg University Hospital	Aalborg	Denmark
ASST Fatebenefratelli Sacco	Milan	Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum	Bad Oeynhausen	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
InnoDiab Forschung GmbH	Essen	Germany
Steno Diabetes Center Copenhagen	Herlev	Denmark
Odense University Hospital	Odense	Denmark
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Nordsjaellands Hospital	Hillerød	Denmark
Rswtsa Makedtrrveb	Herning	Denmark
Aeixymy Uwxvo Sypctfwez Lincgq Du Bkyvnlx	Bologna	Italy
Ahighyn Olaznlhlwte Pffk Geffqejt Xyhrs	Bergamo	Italy
Akh Tkh	Chieri	Italy
Hffpbgnq Ugwulbptdxkei dz A Czcfzn	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	10.11.2023
Germany	Not recruiting	10.11.2023
Italy	Not recruiting	10.11.2023
Spain	Not recruiting	10.11.2023

Trial locations

Investigated drugs:

Finerenone

Finerenone is a medication being studied for its potential to help people with chronic kidney disease and type 1 diabetes. It works by blocking certain receptors in the body that can contribute to kidney damage. The goal of using finerenone in this trial is to see if it can reduce the amount of protein in the urine, which is a sign of kidney damage, over a period of six months. This medication is being tested to see if it can provide better results than the standard treatments currently available.

Investigated diseases:

Chronic kidney disease associated with type 1 diabetes mellitus – This condition involves the gradual loss of kidney function in individuals who have type 1 diabetes. Over time, high blood sugar levels can damage the blood vessels in the kidneys, leading to impaired kidney function. As the disease progresses, the kidneys become less effective at filtering waste and excess fluids from the blood. This can result in the accumulation of waste products in the body, causing symptoms such as fatigue, swelling, and changes in urination. The progression of the disease can vary, but it typically involves a slow decline in kidney function over several years. Regular monitoring and management of blood sugar levels are crucial to slowing the progression of kidney damage.

Trial ID:

2022-503024-27-00

Protocol code:

22267

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Finerenone for Patients with Chronic Kidney Disease and Type 1 Diabetes

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