Study on the Effectiveness and Safety of Finerenone and Empagliflozin in Adults with Chronic Kidney Disease and Type 2 Diabetes

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What is this study about?

This clinical trial is focused on studying the effects of a treatment combination for people with chronic kidney disease and type 2 diabetes. The study will evaluate how well the combination of two medications, finerenone and empagliflozin, works compared to each medication taken alone. Finerenone is a type of medication known as a mineralocorticoid receptor antagonist, which helps to reduce the effects of certain hormones that can harm the kidneys. Empagliflozin is a medication that helps lower blood sugar levels by helping the kidneys remove glucose from the bloodstream.

The purpose of the study is to determine if the combination of these two medications is more effective in reducing a specific measure related to kidney function, known as the urinary albumin-to-creatinine ratio, than taking either medication alone. Participants in the study will be randomly assigned to one of three groups: one group will receive both finerenone and empagliflozin, another group will receive only finerenone, and the third group will receive only empagliflozin. Some participants may receive a placebo, which looks like the medication but does not contain the active ingredient.

The study will last for about six months, during which participants will take the assigned medication daily. Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. The goal is to gather information on the safety and effectiveness of the treatment combination, which could lead to better management of chronic kidney disease in people with type 2 diabetes.

1 joining the study

Upon joining the study, the participant will be informed about the trial’s purpose, which is to evaluate the effectiveness and safety of the combination of finerenone and empagliflozin compared to each drug alone in individuals with chronic kidney disease and type 2 diabetes.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes verifying a diagnosis of chronic kidney disease and type 2 diabetes, as well as ensuring the participant is on a stable dose of either an ACE inhibitor or an angiotensin receptor blocker.

3 medication administration

Participants will be randomly assigned to one of three groups: receiving finerenone (either 10 mg or 20 mg), empagliflozin (10 mg), or a combination of both. All medications are taken orally in the form of film-coated tablets.

4 treatment duration

The treatment will last for 180 days. During this period, participants will take their assigned medication daily as instructed.

5 monitoring and follow-up

Throughout the study, participants will undergo regular monitoring to assess changes in urinary albumin to creatinine ratio (UACR) and other health parameters. This includes visits at specified intervals to evaluate the treatment’s impact and any potential side effects.

6 end of treatment evaluation

At the end of the 180-day treatment period, a final evaluation will be conducted to measure the primary outcomes, including changes in UACR and kidney function.

7 post-treatment follow-up

A follow-up assessment will occur 30 days after the end of treatment to observe any lasting effects or changes in health status.

Who Can Join the Study?

The participant must have a clinical diagnosis of chronic kidney disease (CKD). This means their kidneys are not working as well as they should.
For Part A of the study, the participant’s eGFR (a test that measures kidney function) should be between 40-90 ml/min/1.73m². No more than 20% of participants can have an eGFR greater than 75 ml/min/1.73m². They should also have a past eGFR value of less than 60 ml/min/1.73m² within the last 3 months or a registered diagnosis of CKD.
For Part B of the study, the participant’s eGFR should be between 30-90 ml/min/1.73m², with the same conditions as Part A regarding the percentage of participants and past eGFR values.
The participant’s UACR (a test that measures the amount of albumin in the urine) should be between 100 and 5000 mg/g at the screening visit. This is based on the average of three morning urine samples. They should also have documentation of albuminuria or proteinuria (presence of protein in urine) in their medical records at least 3 months before the screening.
The participant must have type 2 diabetes (T2D), as defined by the American Diabetes Association, with a glycated hemoglobin (HbA1c) level of less than 11% at the screening. HbA1c is a blood test that shows average blood sugar levels over the past 2-3 months.
The participant should be treated with the highest dose they can tolerate of either an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB) for more than 1 month before the screening visit. These are medications used to treat high blood pressure and protect the kidneys.
Participants can be of any gender.
The study includes participants who may be considered vulnerable.

Who Cannot Join the Study?

Patients with severe liver disease cannot participate. This means if your liver is not working well, you may not be eligible.
Patients with a history of heart attack or stroke in the last 6 months are excluded. This means if you had a heart attack or stroke recently, you cannot join.
Patients with uncontrolled high blood pressure are not allowed. This means if your blood pressure is very high and not managed well, you cannot take part.
Patients who are pregnant or breastfeeding cannot participate. This means if you are expecting a baby or nursing, you are not eligible.
Patients with a history of severe allergic reactions to the study drugs are excluded. This means if you had a bad allergy to similar medications, you cannot join.
Patients with certain types of cancer are not allowed. This means if you have cancer that is not well controlled, you cannot participate.
Patients with severe kidney disease not related to diabetes are excluded. This means if your kidney problems are not because of diabetes, you cannot join.
Patients who are currently participating in another clinical trial are not allowed. This means if you are already in a different study, you cannot take part in this one.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Stichting OLVG	Amsterdam	The Netherlands
Die Praxis am Ludwigsplatz	Ludwigshafen Am Rhein	Germany
University Hospital Jena KöR	Jena	Germany
Sydvestjysk Sygehus	Esbjerg	Denmark
Hospital Clinico San Carlos	Madrid	Spain
Katholieke Universiteit te Leuven	Leuven	Belgium
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nimes	Nimes	France
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Edouard Herriot	Lyon	France
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
AZ Sint-Lucas & Volkskliniek	Gent	Belgium
Hausaerztlich-Kardiologisches MVZ Am Felsenkeller GmbH	Dresden	Germany
Hospital Universitario Dr Peset Aleixandre	Valencia	Spain
Albert Schweitzer Ziekenhuis	Dordrecht	The Netherlands
Area Sanitaria De Ferrol	Ferrol	Spain
Hospital Universitario Virgen De Las Nieves	Granada	Spain
HUmani	Charleroi	Belgium
Hospital Quironsalud Barcelona	Barcelona	Spain
Azienda Sociosanitaria Ligure N 4 Sistema Sanitario Regione Liguria	Chiavari	Italy
Azienda Socio Sanitaria Locale N 2 Della Gallura	Olbia	Italy
St. Josefskrankenhaus Heidelberg GmbH	Heidelberg	Germany
Steno Diabetes Center Copenhagen	Herlev	Denmark
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate	Chieti	Italy
Diabeteszentrum-Do Dres. K U. Ch. Busch GbR	Dortmund	Germany
ClinPhenomics CVC GmbH	Frankfurt	Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hospital Universitario Principe De Asturias	Alcala De Henares	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Meander Medical Center	Amersfoort	The Netherlands
Universita’ Di Pisa	Pisa	Italy
Jan Yperman Ziekenhuis	Ieper	Belgium
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo	Milan	Italy
Region Midtjylland	Aarhus	Denmark
Gelre Hospitals	Zutphen	The Netherlands
Hospital Costa del Sol	Marbella	Spain
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Avwbvek Optplzwanrg Ugziwjiltvgzu Pzxky	Parma	Italy
Azfnxdd Spskw Sftucetim Tuvknthlilgj Rvcbntcy	Garbagnate Milanese	Italy
Daaauedk Zsxexag Wnlbkipi Dmyvdfmvdgfwdpx Sftzteqvozpxdymlz Bpcalevoqtjujtcpzovmsujlaxji Gwt	Hamburg	Germany
Ofmkoozjpkyqqngtnygagewgem	Aalst	Belgium
Hlqgsr Hajztlvc	Herlev	Denmark
Cfrzup Habkmyahkjq Uoiqritfomlqy Dv Dflhu	Dijon	France
Cpxy Dw Noxqs	Vandoeuvre Les Nancy	France
Azvlymm Ohjgzsqbveg Prws Ghlxyafr Xzzhy	Bergamo	Italy
Gvpjrt Hwrfckahnvd Utxevuhdfqyeb Pxvib Pbkrowoamnp Ey Nwaoickzduex	Paris	France
Hfsqjwrz Vhsn dnhbwxjg	Barcelona	Spain
Hbkjaksh Uuseapjfbvdqm dh A Clwrga	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	23.06.2022
Denmark	Not recruiting	23.06.2022
France	Not recruiting	23.06.2022
Germany	Not recruiting	23.06.2022
Italy	Not recruiting	23.06.2022
Spain	Not recruiting	23.06.2022
The Netherlands	Not recruiting	23.06.2022

Trial locations

Investigated drugs:

Finerenone is a medication used in this trial to help manage chronic kidney disease in people with type 2 diabetes. It works by blocking certain receptors in the body that can lead to kidney damage. The goal is to see if it can reduce the amount of protein in the urine, which is a sign of kidney health.

Empagliflozin is another medication being tested in the trial. It is used to help control blood sugar levels in people with type 2 diabetes and also has benefits for kidney health. It works by helping the kidneys remove sugar from the body through urine, which can also help protect the kidneys.

The trial is also testing the combination of Finerenone and Empagliflozin together to see if using both medications at the same time is more effective in reducing kidney damage than using either medication alone. The combination aims to provide better protection for the kidneys by using the different ways each medication works.

Chronic Kidney Disease in Type 2 Diabetes Mellitus – This condition occurs when the kidneys are damaged and cannot filter blood as well as they should, often due to the long-term effects of type 2 diabetes. Over time, the damage can worsen, leading to a gradual decline in kidney function. This progression can result in the accumulation of waste products in the blood, causing symptoms such as fatigue, swelling, and changes in urination. As the disease advances, it may lead to complications like high blood pressure and anemia. The progression of kidney damage can vary among individuals, influenced by factors such as blood sugar control and blood pressure management.

Trial ID:

2023-506981-30-00

Protocol code:

21839

NCT ID:

NCT05254002

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness and Safety of Finerenone and Empagliflozin in Adults with Chronic Kidney Disease and Type 2 Diabetes

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?