Study on the Long-Term Safety of Finerenone with ACE Inhibitors or ARBs for Children and Young Adults with Chronic Kidney Disease and Proteinuria

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What is this study about?

This clinical trial is focused on studying the safety of a medication called finerenone in children and young adults aged 1 to 18 years who have chronic kidney disease and a condition called proteinuria, which means there is an excess of protein in the urine. The study will explore how safe it is to use finerenone over a long period when taken alongside another type of medication, either an ACE inhibitor or an angiotensin receptor blocker (ARB). These medications are commonly used to help manage blood pressure and protect the kidneys.

Participants in the study will take finerenone in the form of either a film-coated tablet or granules for oral suspension, depending on their age and body weight. The study will last for 18 months, during which time the participants will continue their usual treatment with an ACE inhibitor or ARB. The goal is to ensure that adding finerenone to their treatment is safe over this extended period.

Throughout the study, researchers will monitor the participants for any side effects and changes in their health, such as variations in blood pressure and potassium levels. The study aims to provide valuable information on the long-term safety of finerenone for young patients with chronic kidney disease and proteinuria, helping to improve treatment options for this condition.

1 joining the study

The study involves children and young adults aged 1 to 18 years with chronic kidney disease and proteinuria.

Participants must have previously participated in the finerenone Phase 3 study FIONA and not have been permanently discontinued from treatment.

Participants must be treated with an ACE inhibitor or angiotensin receptor blocker at optimized doses for at least 30 days prior to joining.

2 medication administration

The study involves taking finerenone, which is available as a film-coated tablet or granules for oral suspension.

The medication is taken orally, and the dosage is adjusted based on age and body weight.

The treatment is administered in addition to an ACE inhibitor or angiotensin receptor blocker.

3 treatment duration

The study lasts for 18 months.

The primary goal is to assess the safety of long-term use of finerenone in combination with other medications.

4 monitoring and assessments

Participants will be monitored for treatment emergent adverse events.

Changes in serum potassium levels and systolic blood pressure will be measured from the start of the study to Day 540.

Secondary assessments include changes in urinary protein-to-creatinine ratio, urinary albumin-to-creatinine ratio, and estimated glomerular filtration rate.

Who Can Join the Study?

  • Participants must be between 1 year and 18 years old at the time of signing the consent form.
  • Participants should have previously taken part in the finerenone Phase 3 study called FIONA and should not have been permanently stopped from treatment by the end of that study.
  • Participants must have a clinical diagnosis of chronic kidney disease (CKD) at the first visit. CKD stages 1-3 mean the kidneys are not working as well as they should, but not severely. This is measured by a test called estimated glomerular filtration rate (eGFR), which should be 30 or more for children aged 1 to under 19 years at the end of the FIONA study and at the first visit.
  • Participants must be treated with a type of medicine called an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at the highest dose they can handle, according to guidelines for managing blood pressure. This treatment should not have changed for at least 30 days before the first visit.
  • The level of potassium (K+) in the blood should be 5.0 or less for children aged 2 years and older, and 5.3 or less for children under 2 years, at both the end of the FIONA study and the first visit.
  • Participants must be able to receive food through normal eating, bottle or cup feeding, or through feeding tubes, with or without breastfeeding.

Who Cannot Join the Study?

  • Children who do not have chronic kidney disease with proteinuria cannot participate. Proteinuria means having too much protein in the urine, which can be a sign of kidney problems.
  • Children who are not in the age range of 2 to 3 years old cannot participate.
  • Children who are not able to take medications called ACEI or ARB cannot participate. These are types of medicines that help control blood pressure and protect the kidneys.
  • Children who have any other medical conditions that might interfere with the study cannot participate.
  • Children who are not able to follow the study procedures or take the study medication as directed cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Hochschule Hannover Hanover Germany
Medical University Of Vienna Vienna Austria
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Medical University Of Graz Graz Austria
Oncopole Claudius Regaud Toulouse France
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
IRCCS Istituto Giannina Gaslini Genoa Italy
Azienda Ospedaliera Universitaria Meyer IRCCS Florence Italy
Universitair Ziekenhuis Gent Gent Belgium
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Hospital Universitario 12 De Octubre Madrid Spain
Specialized Hospital For Active Treatment Of Childrens Diseases Professor Ivan Mitev Sofia Bulgaria
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Nosokomeio Paidon I Agia Sofia Athens Greece
University General Hospital Of Heraklion Heraklion Greece
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Umbal – Prof. D-R Stoyan Kirkovich AD Stara Zagora Bulgaria
Ospedale Pediatrico Bambino Gesu’ Rome Italy
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Athens General Children’s Hospital Panagioti And Aglaia Kyriakou Athens Greece
University Of Debrecen Debrecen Hungary
University General Hospital Of Ioannina Ioannina Greece
Virgen del Rocío University Hospital Sevilla Spain
Odense University Hospital Odense Denmark
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Region Skane Skanes Universitetssjukhus Lund Sweden
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Instytut Pomnik Centrum Zdrowia Dziecka Warsaw Poland
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Karolinska University Hospital Solna Sweden
Semmelweis University Budapest Hungary
Turku University Hospital Turku Finland
Centre Hospitalier Universitaire De Montpellier Montpellier France
Kepler Universitaetsklinikum GmbH Linz Austria
CHC MontLegia Liege Belgium
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku samodzielny publiczny zakład opieki zdrowotnej Bialystok Poland
Rigshospitalet Copenhagen Denmark
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
University Of Pecs Pecs Hungary
Pirkanmaan hyvinvointialue Tampere Finland
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
University Childrens Hospital Queen Fabiola Brussels Belgium
University Of Szeged Szeged Hungary
Uniklinikum Salzburg Salzburg Austria
Clyfsvwgs Uemxvyqnrbzarh Srldkcdva Woluwe-Saint-Lambert Belgium
Uvdrywznvq Mvzlscw Cpptkm Hsepzlhhpjuzvswse Hamburg Germany
Uyebyfomvgntuleatgruy Efpgi Aqt Essen Germany
Urdsrqxdcvzm Mlxwfig Csuzeht Gtoeileqk Groningen The Netherlands
Kokblneqpjdzhwpvkrv Bamz Bonn Germany
Fnkzbhhp nxegdglot Myddl a Hkhmdyt Prague Czechia
Ukiwwql Uxaecqnjdj Hgtwvmlz Uppsala Sweden
Hthggbjm Uyrbmqikyq Cozhbnw Hamahrbr Helsinki Finland
Asxtqy Uqhrqbydur Hnzmkldo Aarhus Denmark
Aovtfot Osfwkmqyhhy Ueumxfoxyflqw Cailufubzqfx Dqbhu Spzcmm E Dzosy Smvkmbw De Tfqzsk Turin Italy
Utolrunxurprkklkfhhxo Miizjwfm Aux Munster Germany
Aabeiud Uujtq Swkhrggoa Lomcdz Dq Blhyigl Bologna Italy
Upjkdfrlkzbctc Csznuga Knduosymg Gdansk Poland
Fdliznspr Pekc Lx Ikxevvnfrbvvy Bqenvvokq Dju Hsdbxgcc Udaorvztaagir Lx Pns Madrid Spain
Cdbzqa Hiezxkkhiv E Unsrmehjxfvtm Dw Cvlcfil Epqtms Coimbra Portugal
Hekajbiw Vrzg drvwrlwo Barcelona Spain
Hznmnxsm Uqchujmyfxkqre Saacwsjsak &uitvol Hxxjekx dd Hokyseecybz STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
08.11.2022
Belgium Belgium
Recruiting
08.11.2022
Bulgaria Bulgaria
Not yet recruiting
08.11.2022
Czechia Czechia
Recruiting
08.11.2022
Denmark Denmark
Recruiting
08.11.2022
Finland Finland
Recruiting
08.11.2022
France France
Recruiting
08.11.2022
Germany Germany
Recruiting
08.11.2022
Greece Greece
Recruiting
08.11.2022
Hungary Hungary
Recruiting
08.11.2022
Italy Italy
Recruiting
08.11.2022
Lithuania Lithuania
Recruiting
08.11.2022
Poland Poland
Recruiting
08.11.2022
Portugal Portugal
Recruiting
08.11.2022
Spain Spain
Recruiting
08.11.2022
Sweden Sweden
Recruiting
08.11.2022
The Netherlands The Netherlands
Recruiting
08.11.2022

Trial locations

Investigated drugs:

Finerenone is a medication being studied for its safety when used long-term in children and young adults with chronic kidney disease and proteinuria. It is taken orally and is adjusted based on age and body weight. The goal is to see if it can be safely added to other treatments for kidney disease.

ACEI (Angiotensin-Converting Enzyme Inhibitors) are medications that help relax blood vessels and reduce blood pressure. They are commonly used to treat conditions like high blood pressure and heart failure. In this study, they are used alongside finerenone to manage chronic kidney disease.

ARB (Angiotensin II Receptor Blockers) are another type of medication that helps lower blood pressure by blocking the action of a natural chemical that narrows blood vessels. Like ACEIs, ARBs are used in this study with finerenone to treat chronic kidney disease in young patients.

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 can lead to a buildup of waste products in the body, causing symptoms like fatigue, swelling, and changes in urination. Over time, the disease can progress to more severe stages, potentially affecting other organs and systems. The progression is often slow, and symptoms may not appear until significant kidney damage has occurred. Management focuses on slowing the progression and addressing symptoms.

Proteinuria – Proteinuria is a condition characterized by the presence of excess protein in the urine, which can be a sign of kidney damage. Normally, kidneys filter waste while retaining essential proteins in the blood, but when damaged, they may allow proteins to leak into the urine. This condition can be a result of various underlying health issues, including chronic kidney disease. It may not cause noticeable symptoms initially, but over time, it can lead to swelling and other complications. Monitoring and managing proteinuria is crucial to prevent further kidney damage.

Trial ID:
2023-504885-50-00
Protocol code:
20186
NCT ID:
NCT05457283
Trial Phase:
Therapeutic confirmatory (Phase III)

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