A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria
Launched by BAYER · Jul 11, 2022
Trial Information
Current as of May 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the safety and effectiveness of a medication called finerenone when taken alongside other common treatments (ACE inhibitors or ARBs) for children and young adults aged 1 to 18 who have chronic kidney disease (CKD) and proteinuria, which means their kidneys are leaking protein into their urine. The goal is to see if using finerenone can help improve kidney function and reduce protein levels in urine over a period of 18 months.
To be eligible for the trial, participants must have previously taken part in another study of finerenone and must be currently diagnosed with CKD. They should also be receiving treatment with an ACE inhibitor or ARB. Throughout the study, participants will have regular check-ups, which will include measuring their blood pressure, taking blood and urine samples, and monitoring their overall health. It’s important to note that the study team will be closely watching for any health issues that arise during the trial. If you're considering participation, the team will provide detailed information and support to ensure you understand what to expect during this experience.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Participants must be ≥1 year to 18 years of age, at the time of signing the informed consent/assent.
- • Prior participation in the finerenone Phase 3 study FIONA (19920) and not permanently discontinued from treatment by the end of treatment (EoT) visit in FIONA.
- • Participants must have a clinical diagnosis of chronic kidney disease (CKD) at Visit 1 which is defined as
- • CKD stages 1-3 (estimated glomerular filtration rate \[eGFR\] ≥30 mL/min/1.73m\^2) for children ≥1 year to \<19 years of age at FIONA EoT and at Visit 1
- • Treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at optimized doses defined as maximally tolerable doses within the recommended dose range according to guidelines on blood pressure (BP) management, unchanged for at least 30 days prior to Visit 1.
- • K+ ≤5.0 mmol/L for children ≥2 years of age at both FIONA EoT and Visit 1, and ≤5.3 mmol/L for children \<2 years of age at both FIONA EoT and Visit 1
- • Participants who have reached legal age of consent: Capable of giving signed informed consent.
- • Participant is able to receive enteral feeding (solid food, bottle or cup fed, feeding through nasogastric or gastric feeding tubes) with or without breastfeeding.
- Exclusion Criteria:
- • Planned urological surgery expected to influence renal function
- • Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame
- • Systemic hypertension Stage 2 defined according to institutional guidelines on BP management at Visit 1.
- • Systemic hypotension defined as symptomatic hypotension or a mean systolic BP below the 5th percentile for age, sex and height but no lower than 80 mmHg for participants \<18 years and symptomatic hypotension or a mean systolic blood pressure (SBP) \<90 mmHg in participants ≥18 years at Visit 1.
- • Known hypersensitivity to the study treatment (active substance or excipients)
- • Severe hepatic insufficiency defined by e.g. Child-Pugh C or analogous scores.
- • Participants using rituximab, cyclophosphamide, abatacept, or intravenous glucocorticoids
- • Concomitant therapy with a mineralocorticoid receptor antagonist (MRA)(eplerenone, spironolactone, esaxerenone, canrenone), any renin inhibitor (aliskiren, enalkiren, remikiren), any sodium-glucose co-transporter-2 (SGLT2) inhibitor (SGLT2i), sacubitril/valsartan combination (ARNI), or potassium-sparing diuretic (amiloride, triamterene)
- • Concomitant therapy with both ACEI and ARBs together
- • Concomitant therapy with strong cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, moderate or strong CYP3A4 inducers
- • Previous assignment to treatment during this study
- • Simultaneous participation in another interventional clinical study (e.g., Phase 1 to 4 clinical studies).
- • Any suspected (serious) adverse event related to study intervention which led to permanent discontinuation during the FIONA study.
- • Pregnant or breastfeeding or intention to become pregnant during the study
About Bayer
Bayer is a global healthcare and life sciences company dedicated to advancing health and well-being through innovative research and development. With a strong commitment to improving patient outcomes, Bayer conducts clinical trials across various therapeutic areas, including oncology, cardiology, and women's health. The company leverages cutting-edge science and technology to develop breakthrough therapies, while adhering to the highest standards of ethical practices and regulatory compliance. Through collaboration with healthcare professionals and research institutions, Bayer aims to bring transformative solutions to the market, ultimately enhancing the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Philadelphia, Pennsylvania, United States
Iowa City, Iowa, United States
Paris, , France
Washington, District Of Columbia, United States
Madrid, , Spain
Utrecht, , Netherlands
Salt Lake City, Utah, United States
Seattle, Washington, United States
South Brisbane, Queensland, Australia
Gent, , Belgium
Uppsala, , Sweden
Madrid, , Spain
Nottingham, , United Kingdom
Groningen, , Netherlands
Toulouse Cedex 9, , France
Stockholm, , Sweden
Parkville, Victoria, Australia
Erlangen, Bayern, Germany
Lodz, , Poland
Praha 2, , Czechia
Seoul, , Korea, Republic Of
Montreal, Quebec, Canada
Seoul, , Korea, Republic Of
Gdansk, , Poland
Birmingham, West Midlands, United Kingdom
Praha 5, , Czechia
Washington, District Of Columbia, United States
Ankara, , Turkey
Graz, Steiermark, Austria
Hamburg, , Germany
Manchester, , United Kingdom
Torino, , Italy
Budapest, , Hungary
Heidelberg, Baden Württemberg, Germany
Belo Horizonte, Minas Gerais, Brazil
London, , United Kingdom
Seattle, Washington, United States
Thessaloniki, , Greece
Essen, Nordrhein Westfalen, Germany
Lund, , Sweden
Pecs, , Hungary
Debrecen, , Hungary
Heraklion, , Greece
Lausanne, Vaud, Switzerland
Boston, Massachusetts, United States
Turku, , Finland
Multiple Locations, , Korea, Republic Of
Toronto, Ontario, Canada
Bologna, Emilia Romagna, Italy
Strasbourg, , France
Bruxelles Brussel, , Belgium
Bordeaux, , France
Strasbourg, , France
Krakow, , Poland
Multiple Locations, , Sweden
Praha 2, , Czechia
Warszawa, , Poland
Multiple Locations, , Germany
Montpellier, , France
Milano, Lombardia, Italy
Beer Sheva, , Israel
Seongnam Si, Gyeonggido, Korea, Republic Of
Hannover, Niedersachsen, Germany
Münster, Nordrhein Westfalen, Germany
Monterrey, Nuevo Leon, Mexico
Istanbul, , Turkey
Cincinnati, Ohio, United States
Copenhagen, , Denmark
Petach Tikva, , Israel
Multiple Locations, , Finland
Multiple Locations, , Greece
Málaga, , Spain
Helsinki, , Finland
Curitiba, Parana, Brazil
Thessaloniki, , Greece
Wroclaw, , Poland
Multiple Locations, , United Kingdom
Multiple Locations, , France
Multiple Locations, , Italy
Yangsan, Gyeongsangnamdo, Korea, Republic Of
Multiple Locations, , Belgium
Multiple Locations, , Canada
Multiple Locations, , Spain
Wien, , Austria
La Jolla, California, United States
Multiple Locations, , Argentina
Multiple Locations, , Austria
Multiple Locations, , Denmark
Multiple Locations, , Netherlands
Multiple Locations, , Turkey
Wroclaw, , Poland
Clayton, Victoria, Australia
Multiple Locations, , Switzerland
Palo Alto, California, United States
Salzburg, , Austria
Linz, Oberösterreich, Austria
Buenos Aires, , Argentina
Multiple Locations, , Portugal
Multiple Locations, , Australia
Multiple Locations, , Czechia
Multiple Locations, , Hungary
Multiple Locations, , Israel
Roma, Lazio, Italy
Multiple Locations, , Poland
Ankara, , Turkey
Genova, Liguria, Italy
Klaipeda, , Lithuania
Ankara, , Turkey
Salt Lake City, Utah, United States
Kaunas, , Lithuania
Ioannina, , Greece
Nahariya, , Israel
Szeged, , Hungary
Bialystok, , Poland
Baltimore, Maryland, United States
Lisboa, , Portugal
La Plata, Buenos Aires, Argentina
Kansas City, Missouri, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
San Antonio, Texas, United States
Bruxelles Brussel, , Belgium
Calgary, Alberta, Canada
Odense C, , Denmark
århus N, , Denmark
Tampere, , Finland
Bordeaux Cedex, , France
Bron, , France
Heidelberg, Baden Württemberg, Germany
Athens, , Greece
Crete, , Greece
Jerusalem, , Israel
Tel Aviv, , Israel
Daegu, Daegu Gwang''Yeogsi, Korea, Republic Of
Yangsan Si, Gyeongsangnamdo, Korea, Republic Of
Multiple Locations, , Lithuania
Porto, , Portugal
Basel, Basel Stadt, Switzerland
Istanbul, , Turkey
Philadelphia, Pennsylvania, United States
Bonn, Nordrhein Westfalen, Germany
Berlin, , Germany
Barcelona, , Spain
Barcelona, , Spain
Ankara, , Turkey
Ankara, , Turkey
Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina
Vilnius, , Lithuania
Kolkata, , India
San Luis, , Argentina
Ribeirão Preto/Sp, Sao Paulo, Brazil
Leuven, , Belgium
Münster, Nordrhein Westfalen, Germany
Hollywood, Florida, United States
Ciudad De Buenos Aires, , Argentina
Santa Fe, , Argentina
Athens, , Greece
Istanbul, , Turkey
Liège, , Belgium
Geneva, , Switzerland
Phoenix, Arizona, United States
Esplugues De Llobregat, Barcelona, Spain
Sevilla, , Spain
Braga, , Portugal
Ankara, , Turkey
Ankara, , Turkey
Atlanta, Georgia, United States
Glasgow, Stratchclyde, United Kingdom
Birmingham, West Midlands, United Kingdom
Strasbourg, , France
Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina
Beer Sheva, , Israel
Istanbul, , Turkey
San Luis, Provincia De San Luis, Argentina
Ioannina, , Greece
Roma, Lazio, Italy
Baltimore, Maryland, United States
Cincinnati, Ohio, United States
Ciudad Autonoma De Buenos Aire, Ciudad Auton. De Buenos Aires, Argentina
Santa Fe, Provincia De Santa Fe, Argentina
Buenos Aires, , Argentina
Helsinki, , Finland
Tampere, , Finland
Athens, , Greece
Genova, Liguria, Italy
Firenze, , Italy
Missing, Lisboa, Portugal
Porto, , Portugal
Barcelona, , Spain
Málaga, , Spain
Ankara, , Turkey
Istanbul, , Turkey
Glasgow, Stratchclyde, United Kingdom
Lisboa, , Portugal
Copenhagen, , Denmark
århus N, , Denmark
São Paulo, Sao Paulo, Brazil
Odense C, , Denmark
Bologna, Emilia Romagna, Italy
Athens, , Greece
Roma, Lazio, Italy
Genova, Liguria, Italy
Milano, Lombardia, Italy
Firenze, , Italy
Torino, , Italy
Coimbra, , Portugal
Sao Paulo, Sp, Brazil
Sao Paulo, , Brazil
México D.F., Distrito Federal, Mexico
México, D.F., Distrito Federal, Mexico
Gdansk, , Poland
Washington, District Of Columbia, United States
Boston, Massachusetts, United States
Kansas City, Missouri, United States
Philadelphia, Pennsylvania, United States
Delhi, , India
Heraklion, , Greece
Ioannina, , Greece
Thessaloniki, , Greece
Atlanta, Georgia, United States
Baltimore, Maryland, United States
Calgary, Alberta, Canada
Praha 2, , Czechia
Athens, , Greece
Athens, , Greece
Palo Alto, California, United States
Ciudad Autónoma De Buenos Aire, Ciudad Auton. De Buenos Aires, Argentina
Buenos Aires, , Argentina
Ciudad Autonoma De Buenos Aire, , Argentina
Montpellier, , France
Hannover, Niedersachsen, Germany
Aguascalientes, Agguascalientes, Mexico
Bordeaux Cedex, , France
Glasgow, Stratchclyde, United Kingdom
Los Angeles, California, United States
Portland, Oregon, United States
Athens, , Greece
Veracruz, , Mexico
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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