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
An 18-month, Open-label, Single-arm Safety Extension Study of an age-and Bodyweight-adjusted Oral Finerenone Regimen, in Addition to an ACEI or ARB, for the Treatment of Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria
- Chronic Kidney Disease
- Proteinuria
- Children
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Bayer
- Enrolment target
- 100
- Started
- 8 November 2022
- Main results due
- 7 August 2028
- Study sites
- 151
- Registry updated
- 24 September 2026
Can you take part?
- Ages 1 year to 18 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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
What this study is about
In the sponsor’s own words, from the registry.
Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine.
The kidneys filter waste and fluid from the blood to form urine. In children with CKD, the kidney´s filters do not work as well as they should. This can lead to accumulation of waste and fluid in the body and proteinuria. CKD can lead to other medical problems, such as high blood pressure, also known as hypertension. Vice versa, hypertension and proteinuria can also contribute to worsening of CKD. Therefore, the treatment of CKD aims to control blood pressure and proteinuria. There are treatments available for doctors to prescribe to children with CKD and hypertension and/or proteinuria. These include "angiotensin-converting enzyme inhibitors" (ACEI) and "angiotensin receptor blockers" (ARB). Both ACEI and ARB can help improve kidney function by reducing the activity of the renin-angiotensin-aldosterone system (RAAS). The RAAS is a system that works with the kidneys to control blood pressure and the balance of fluid and electrolytes in the blood. In people with CKD, the RAAS is often too active, which can impair the ability of the kidneys to work properly and cause hypertension and proteinuria. However, ACEI or ARB treatment alone does not work for all patients with CKD as they only target the angiotensin part of the renin-angiotensin-aldosterone system.
The study treatment, finerenone, is expected to help control RAAS overactivation together with an ACEI or ARB.
So, the researchers in this study want to learn more about whether finerenone given in addition to either an ACEI or ARB can help their kidney function.
The main purpose of this study is to learn how safe the treatment is when used of finerenone in addition to an ACEI or ARB in long-term.
To see how safe the treatment is, the study team will collect information on medical problems which are also known as "treatment emergent adverse events" (TEAEs). And they will also collect levels of an electrolyte called potassium in the blood by taking blood samples, and measure blood pressure during the study.
The secondary purpose of this study is to learn how well long-term use of finerenone can reduce the amount of protein in the participants' urine and benefit kidney function when taken with standard of care.
To see how the treatment works, the study team will collect participants' urine samples to assess urinary albumin-to-creatinine ratio (UACR) and urinary protein-to-creatinine ratio (UPCR), which are important assessments for calculating the level of protein in the urine. Researchers will also collect blood samples to analyze serum creatinine and calculate estimated glomerular filtration rate (eGFR). A significant decline in eGFR indicates worsening kidney function.
The study will include participants who had previously participated in FIONA study (NCT05196035). The participants will be aged from 1 year up to 18 years.
The participants will be in the study for approximately 19 months. They will take study treatment for up to 18 months and will be follow up for 1 month. During this period, at least 12 visits are planned for patients who newly start finerenone, and at least 8 visits for patients who already received finerenone.
In the visit, the study team will:
* have their blood pressure, heart rate, temperature, height and weight measured * have blood and urine samples taken * have physical examinations * have their heart examined by an electrocardiogram and echocardiography (a sonogram of the heart) * answer questions about their medication and whether they have any adverse events, or have their parents or guardian's answer * answer questions about how they are feeling, or have their parents or guardian's answer * answer question about how they like the study medication, or have their parents or guardian's answer The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
The doctors will check the participants' health about 30 days after the participants take their last treatment.
Study sites(151)
Phoenix Children's Hospital | Main - Transplant Department
Phoenix, Arizona, United States
Withdrawn
Cedars-Sinai Samuel Oschin Cancer Center
Los Angeles, California, United States
Withdrawn
Lucille Packard Children's Hospital Stanford - Pediatric Nephrology
Palo Alto, California, United States
Active, not recruiting
Rady Children's Hospital San Diego - Cardiology
San Diego, California, United States
Withdrawn
Children's National Hospital - Nephrology
Washington D.C., District of Columbia, United States
Withdrawn
Memorial Transplant Institute - Pediatric Nephrology
Hollywood, Florida, United States
Withdrawn
Emory University Hospital/Children's Healthcare of Atlanta - Nephrology
Atlanta, Georgia, United States
Withdrawn
University of Iowa Health Care Medical Center - Nephrology
Iowa City, Iowa, United States
Withdrawn
The Charlotte R. Bloomberg Children's Center Building - Nephrology
Baltimore, Maryland, United States
Active, not recruiting
Boston Children's Hospital - Main Campus - Nephrology
Boston, Massachusetts, United States
Withdrawn
Children's Mercy Hospital Kansas City - Nephrology
Kansas City, Missouri, United States
Withdrawn
Cincinnati Children's Hospital Medical Center | Division of Nephrology and Hypertension
Cincinnati, Ohio, United States
Withdrawn
Cleveland Clinic | Pediatric Nephrology
Cleveland, Ohio, United States
Completed
OHSU Doernbecher Children's Hospital - Neurology
Portland, Oregon, United States
Withdrawn
Children's Hospital of Philadelphia - Nephrology
Philadelphia, Pennsylvania, United States
Withdrawn
University Hospital - San Antonio - Pediatric Nephrology
San Antonio, Texas, United States
Withdrawn
Eccles Primary Children's Outpatient Services - Nephrology
Salt Lake City, Utah, United States
Active, not recruiting
Seattle Children's Hospital - Nephrology
Seattle, Washington, United States
Withdrawn
Clinica de Nefrologia, Urologia y Enfermedades Cardiovascualares | Santa Fe, Argentina
Santa Fe, Santa Fe Province, Argentina
Withdrawn
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Active, not recruiting
Hospital de Pediatría Juan P. Garrahan
Buenos Aires, Argentina
Withdrawn
Hospital General de Ninos Pedro de Elizalde | Nephrology Department
Buenos Aires, Argentina
Active, not recruiting
Hospital General de Ninos Ricardo Gutierrez | Pediatric Nephrology Department
Buenos Aires, Argentina
Recruiting
Centro de Rehabilitacion Cardiovascular | San Luis, Argentina
San Luis, Argentina
Active, not recruiting
Queensland Children's Hospital
South Brisbane, Queensland, Australia
Active, not recruiting
Monash Children's Hospital
Clayton, Victoria, Australia
Withdrawn
Royal Children's Hospital Melbourne
Parkville, Victoria, Australia
Recruiting
Uniklinikum Salzburg - Landeskrankenhaus
Vienna, State of Vienna, Austria
Withdrawn
Universitätsklinikum AKH Wien
Vienna, State of Vienna, Austria
Withdrawn
Medizinische Universität Graz, Landeskrankenhaus-Universitätsklinikum Graz
Graz, Styria, Austria
Withdrawn
Kepler Universitätsklinikum Campus IV
Innsbruck, Tyrol, Austria
Completed
Huderf / Ukzkf
Brussels, Brussels Capital, Belgium
Withdrawn
CU Saint-Luc/UZ St-Luc
Brussels, Brussels Capital, Belgium
Withdrawn
UZ Gent
Ghent, East Flanders, Belgium
Active, not recruiting
UZ Gasthuisberg - Pediatric Nephrology
Leuven, Flemish Brabant, Belgium
Completed
CHC Montlégia - Pediatrics
Liège, Belgium
Withdrawn
Hospital Pequeno Principe
Curitiba, Paraná, Brazil
Recruiting
Hosp Clínicas Facult. Med. de Ribeirão Preto / USP
Ribeirão Preto, São Paulo, Brazil
Active, not recruiting
Hospital Infantil Sabará - Instituto PENSI - Pesquisa e Ensino em Saúde Infantil
São Paulo, Brazil
Withdrawn
Instituto da Crianca e do Adolescente
São Paulo, Brazil
Not yet recruiting
Hospital PUC-Campinas | Centro de Pesquisa Clínica Sao Lucas
São Paulo, Brazil
Recruiting
Santa Casa de Misericórdia de Belo Horizonte
São Paulo, Brazil
Recruiting
UMHAT Sveti Georgi
Plovdiv, Plovdiv Province, Bulgaria
Recruiting
SHATPD "Prof. Ivan Mitev"
Sofia, Sofia City Province, Bulgaria
Withdrawn
MHAT prof. Stoyan Kirkovitch AD
Stara Zagora, Stara Zagora Province, Bulgaria
Withdrawn
Alberta Children's Hospital | Nephrology Clinic
Calgary, Alberta, Canada
Withdrawn
Centre hospitalier universitaire Sainte-Justine | Cardiology
Montreal, Quebec, Canada
Completed
Všeobecná fakultní nemocnice v Praze
Prague, Prague, Czechia
Completed
Fakultní nemocnice Motol a Homolka, Pracoviště MOTOL
Prague, Prague, Czechia
Active, not recruiting
Rigshospitalet - Børn og Unge
Copenhagen, Capital Region / Region Hovedstaden, Denmark
Withdrawn
Aarhus Universitetshospital - Børn og Unge
Aarhus N, Central Denmark Region / Region Midtjylland, Denmark
Completed
Odense Universitetshospital - HC Andersen Børne og Ungehospital
Odense, Region of Southern Denmark / Region Syddanmark, Denmark
Active, not recruiting
Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS) - Lasten lääketutkimuskeskus PeeTU
Tampere, Pirkanmaa, Finland
Recruiting
Turun yliopistollinen keskussairaala
Turku, Southwest Finland, Finland
Withdrawn
HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Uusi lastensairaala, nefrologia
Helsinki, Uusimaa, Finland
Recruiting
CHU bordeaux - Hopital Pellegrin
Bordeaux, New Aquitaine, France
Withdrawn
CHU Toulouse - Hopital des enfants
Toulouse, Occitanie, France
Completed
CHU Lyon - Hopital Femme Mere Enfant - Service de nephrologie-rhumatologie-dermatologie pediatriques
Bron, France
Completed
CHU Montpellier - Hopital Arnaud de Villeneuve - Service nephrologie pediatrique
Montpellier, France
Active, not recruiting
CHU Strasbourg - Hopital Hautepierre - Service nephrologie pediatrique
Strasbourg, France
Withdrawn
Showing 60 of 151 sites — filter to narrow it down. 23 of the 151 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT05457283. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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