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Study on the Effectiveness and Safety of Finerenone for Adults with Non-Diabetic Chronic Kidney Disease

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Finerenone in patients with non-diabetic chronic kidney disease. Chronic kidney disease is a condition where the kidneys gradually lose their ability to filter waste from the blood. The study aims to determine if Finerenone, when added to the usual care, can slow down the progression of kidney disease compared to a placebo.

Participants in the study will receive either Finerenone or a placebo, in addition to their standard treatment. The medication is taken orally in the form of a film-coated tablet. The study will monitor the participants over a period to observe any changes in their kidney function and overall health. The main goal is to see if Finerenone can delay the worsening of kidney disease.

Throughout the study, researchers will also keep track of any side effects or health issues that may arise. The study is designed to provide valuable information on the safety and effectiveness of Finerenone for people with non-diabetic chronic kidney disease, potentially offering a new option for managing this condition.

1 joining the study

Upon joining the study, the participant will be randomly assigned to receive either the medication finerenone or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

The study is designed to assess the effectiveness and safety of finerenone in slowing the progression of kidney disease in individuals with non-diabetic chronic kidney disease.

2 medication administration

Participants will take the assigned medication orally in the form of a film-coated tablet. The specific dosage and frequency will be determined by the study protocol and communicated to the participant at the start of the trial.

The medication will be taken in addition to the participant’s standard care, which includes a stable and maximum tolerated dose of an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB).

3 monitoring and assessments

Throughout the study, participants will undergo regular monitoring to assess kidney function and overall health. This includes measuring the estimated glomerular filtration rate (eGFR) and urine albumin/creatinine ratio (UACR).

Participants will also be monitored for any adverse events or side effects related to the treatment.

4 study duration

The study is expected to last until February 2026, with participants being followed for a period of up to 32 months from the start of their participation.

The primary goal is to measure the change in kidney function over time, specifically the rate of change in eGFR.

5 end of study

At the conclusion of the study, participants will have a final assessment to evaluate the overall impact of the treatment on kidney disease progression.

The results will contribute to understanding the effectiveness and safety of finerenone in treating non-diabetic chronic kidney disease.

Who Can Join the Study?

  • You must have a clinical diagnosis of chronic kidney disease. This means your kidneys are not working as well as they should for a long time, but it is not caused by diabetes.
  • Your urine albumin/creatinine ratio (UACR) should be between 200 and 3500 mg/g. This is a test that checks for protein in your urine, which can be a sign of kidney problems.
  • Your estimated glomerular filtration rate (eGFR) should be between 25 and 90 mL/min/1.73m². This is a test that measures how well your kidneys are filtering your blood.
  • You need to have a record of albuminuria/proteinuria in your medical records at least 3 months before the screening. This means there should be a history of protein in your urine.
  • You should be on a stable and maximum tolerated dose of an Angiotensin converting enzyme inhibitor (ACEI) or Angiotensin receptor blocker (ARB) for at least 4 weeks before the screening. These are medications that help control blood pressure and protect the kidneys.
  • Your potassium (K+) level should be 4.8 mmol/L or lower at screening. Potassium is a mineral in your blood that needs to be at a safe level.
  • Both men and women can participate in the study.
  • The study includes people who are considered part of a vulnerable population, meaning they might need extra protection or care.

Who Cannot Join the Study?

  • Patients with diabetes cannot participate. Diabetes is a condition where the body has trouble managing sugar levels.
  • Patients with severe liver disease are excluded. Liver disease affects how the liver works, which is important for overall health.
  • Patients who have had a kidney transplant cannot join. A kidney transplant is when a person receives a new kidney from a donor.
  • Patients with uncontrolled high blood pressure are not eligible. High blood pressure means the force of blood against the artery walls is too high.
  • Patients who are pregnant or breastfeeding cannot participate. Pregnant means expecting a baby, and breastfeeding means feeding a baby with milk from the breast.
  • Patients with a history of allergic reactions to similar medications are excluded. An allergic reaction is when the body reacts badly to a substance.
  • Patients currently participating in another clinical trial are not eligible. This means they are already part of a different study.
  • Patients with severe heart failure cannot join. Heart failure is when the heart doesn’t pump blood as well as it should.
  • Patients with active cancer are excluded. Active cancer means the cancer is currently growing or spreading.
  • Patients with severe lung disease cannot participate. Lung disease affects how well the lungs work, which is important for breathing.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli Naples Italy
Unidade Local De Saude De Lisboa Ocidental E.P.E. Carnaxide Portugal
Sydvestjysk Sygehus Esbjerg Denmark
Katholieke Universiteit te Leuven Leuven Belgium
MUDr. Petr Buček s.r.o. Frydek-Mistek Czechia

Other Sites

Site Name City Country Status
Kistarcsai Flor Ferenc Korhaz Kistarcsa Hungary
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione Pavia Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Algemeen Ziekenhuis Delta Roeselare Belgium
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Algemeen Ziekenhuis Groeninge Kortrijk Belgium
University General Hospital Of Heraklion Heraklion Greece
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Area Sanitaria De Ferrol Ferrol Spain
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Azienda Socio Sanitaria Territoriale Ovest Milanese Legnano Italy
Medical center 4LIFE Ltd. Burgas Bulgaria
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD Gorna Oryahovitsa Bulgaria
Istituto Di Ricerche Farmacologiche Mario Negri Ranica Italy
Hippokration Hospital Athens Greece
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
University Teaching Hospital Markusovszky Szombathely Hungary
Medical Center Hera EOOD Sofia Bulgaria
University General Hospital Of Ioannina Ioannina Greece
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
Odense University Hospital Odense Denmark
Fakultni Nemocnice Brno Brno Czechia
Hospital Universitario Principe De Asturias Alcala De Henares Spain
General University Hospital Of Patras Patras Greece
Diagnostic Consultation Center XX-Sofia EOOD Sofia Bulgaria
Holbaek Sygehus Holbæk Denmark
Region Midtjylland Aarhus Denmark
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Medifarma-98 Kft. Nyiregyhaza Hungary
Rigshospitalet Copenhagen Denmark
Medical Center Viva Phoenix OOD Dobrich Bulgaria
Medical Centre Nevromedics EOOD Veliko Tirnovo Bulgaria
Ckpkfggfo Ursodmnfvlqqne Smevsvtjv Woluwe-Saint-Lambert Belgium
Abdetlo Obysmajexqw Usybubbvlgtbs Pusjp Parma Italy
Avnvoov Snums Smwhgqfcy Thgwudcjaacv Bxhadqe (dbll Bktizcja Desio (MB) Italy
Nmjezjchvw smyvvo Prague Czechia
Gbhpdsj Hcctzbzm Ol Aeox Arta Greece
Arcpzjg Sdtjg Sqargfvpg Tbcwjlhjplev Rdwmjjlx Garbagnate Milanese Italy
Kldillia Dsjuguob Kzeyai Nagykanizsa Hungary
Lzqjh Gyhswwh Hsaxuudm Oz Alkifp Athens Greece
Hemhlz Hgkqgdxy Herlev Denmark
Alodyha Uue Ixofh Dl Rjurtc Ebamaa Reggio Emilia Italy
Aghutnr Umlca Sufoeoydr Lskrzb Dv Budztxo Bologna Italy
Hpwkqatb Vqxi duntsotq Barcelona Spain
Nmxohwyfs Zyrqeq pxdltrbdcsz omyrfomqba Znojmo Czechia
Pjodqpdh Hlvlgtnv spqgpe Plzen Czechia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
02.11.2021
Bulgaria Bulgaria
Not recruiting
02.11.2021
Czechia Czechia
Not recruiting
02.11.2021
Denmark Denmark
Not recruiting
02.11.2021
Greece Greece
Not recruiting
02.11.2021
Hungary Hungary
Not recruiting
02.11.2021
Italy Italy
Not recruiting
02.11.2021
Portugal Portugal
Not recruiting
02.11.2021
Spain Spain
Not recruiting
02.11.2021

Trial locations

Investigated drugs:

Finerenone is a medication being studied for its ability to slow down the progression of kidney disease in patients who do not have diabetes. It is being tested to see if it can provide additional benefits when used alongside the standard treatments that patients are already receiving for their kidney condition.

Investigated diseases:

Non-diabetic chronic kidney disease – This condition involves the gradual loss of kidney function over time in individuals who do not have diabetes. 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, symptoms such as fatigue, swelling in the legs and ankles, and changes in urination patterns may occur. The progression of the disease can vary, with some individuals experiencing a slow decline in kidney function, while others may see a more rapid deterioration. The condition can eventually lead to kidney failure, requiring dialysis or a kidney transplant. Regular monitoring and lifestyle adjustments are often necessary to manage the disease effectively.

Trial ID:
2023-506897-11-00
Protocol code:
21177
NCT ID:
NCT05047263
Trial Phase:
Therapeutic confirmatory (Phase III)

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