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

Chronic Kidney Disease Clinical Trial

— FIONA OLE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05457283
• Other study ID #: 20186
• Secondary ID: 2023-504885-50-0
• Status: Recruiting
• Phase: Phase 3
• Start date: November 8, 2022
• Est. completion date: September 10, 2028

Study information

• Verified date: April 2024
• Source: Bayer
• Contact: Bayer Clinical Trials Contact
• Phone: (+)1-888-84 22937
• Email: clinical-trials-contact[@]bayer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 10, 2028
• Est. primary completion date: August 11, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Children
• Chronic Kidney Disease
• Kidney Diseases
• Proteinuria
• Renal Insufficiency, Chronic

Intervention

Drug:
• Finerenone (Kerendia, BAY94-8862)
Finerenone in different doses, treatment duration will be 540 ±7 days.

Locations

Country	Name	City	State
Argentina	Hospital de Niños "Ricardo Gutiérrez"	Buenos Aires	Ciudad Auton. De Buenos Aires
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires
Argentina	Hospital General de Niños Pedro de Elizalde	Ciudad de Buenos Aires
Argentina	Hospital de Niños Sor María Ludovica	La Plata	Buenos Aires
Argentina	Many Locations	Multiple Locations
Argentina	Centro de Rehabilitacion Cardiovascular | San Luis, Argentina	San Luis
Argentina	Clinica de Nefrologia, Urologia y Enfermedades Cardiovascualares - Santa Fe, Argentina	Santa Fe
Australia	Monash Children's Hospital	Clayton	Victoria
Australia	Many Locations	Multiple Locations
Australia	Royal Children's Hospital Melbourne	Parkville	Victoria
Australia	Queensland Children's Hospital	South Brisbane	Queensland
Austria	Medizinische Universität Graz	Graz	Steiermark
Austria	Kepler Universitätsklinikum Campus IV	Linz	Oberösterreich
Austria	Many Locations	Multiple Locations
Austria	Uniklinikum Salzburg - Landeskrankenhaus	Salzburg
Austria	Universitätsklinikum AKH Wien	Wien
Belgium	CU Saint-Luc/UZ St-Luc	Bruxelles - Brussel
Belgium	Huderf / Ukzkf	Bruxelles - Brussel
Belgium	UZ Gent	Gent
Belgium	UZ Gasthuisberg - Pediatric Nephrology	Leuven
Belgium	CHC Montlégia - Pediatrics	Liège
Belgium	Many Locations	Multiple Locations
Canada	Alberta Children's Hospital, University of Calgary	Calgary	Alberta
Canada	CHU Sainte-Justine	Montreal	Quebec
Canada	Many Locations	Multiple Locations
Canada	The Hospital for Sick Children (SickKids)	Toronto	Ontario
Czechia	Many Locations	Multiple Locations
Czechia	Vseobecna fakultni nemocnice v Praze	Praha 2
Czechia	Fakultni nemocnice v Motole	Praha 5
Denmark	Aarhus Universitetshospital, Skejby	Århus N
Denmark	Rigshospitalet, Dept Pediatrics & Adelescent Med.	Copenhagen
Denmark	Many Locations	Multiple Locations
Denmark	Odense, HC Andersen	Odense C
Finland	HUS Uusi lastensairaala	Helsinki
Finland	Many Locations	Multiple Locations
Finland	Pediatric Early Phase Trial Unit, Tampere University Hospita	Tampere
Finland	Turun yliopistollinen keskussairaala	Turku
France	Hôpital Pellegrin - Bordeaux	Bordeaux
France	CHU de Lyon - Hopital Femme Mère Enfant	Bron
France	Hôpital Arnaud de Villeneuve - Montpellier	Montpellier
France	Many Locations	Multiple Locations
France	Hopital Robert Debre	Paris
France	CHU STRASBOURG - Hôpital de Hautepierre	Strasbourg
France	Hôpital des Enfants	TOULOUSE Cedex 9
Germany	Charité / Pädiatrie	Berlin
Germany	Kindernierenzentrum Bonn	Bonn	Nordrhein-Westfalen
Germany	Kindernierenzentrum Bonn	Bonn	Nordrhein-Westfalen
Germany	Universitätsklinikum Erlangen	Erlangen	Bayern
Germany	Universitätsklinikum Essen	Essen	Nordrhein-Westfalen
Germany	Universitätsklinikum Hamburg Eppendorf (UKE)	Hamburg
Germany	Medizinische Hochschule Hannover (MHH)	Hannover	Niedersachsen
Germany	Universitätsklinikum Heidelberg	Heidelberg	Baden-Württemberg
Germany	Many Locations	Multiple Locations
Germany	Universitätsklinikum Münster (UKM)	Münster	Nordrhein-Westfalen
Greece	AGIA SOFIA Children's Hospital	Athens
Greece	Children's Hospital of Athens P&A Kyriakou	Athens
Greece	University General Hospital of Heraklion	Crete
Greece	Ioannina University General Hospital	Ioannina
Greece	Many Locations	Multiple Locations
Greece	Hippokration General Hospital of Thessaloniki	Thessaloniki
Hungary	Semmelweis University	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Many Locations	Multiple Locations
Hungary	Pecsi Tudomanyegyetem Klinikai Kozpont	Pecs
Hungary	SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont	Szeged
Israel	Soroka University Medical Center	Beer Sheva
Israel	Wilf Children's Hospital Shaare Zedek Medical Center	Jerusalem
Israel	Many Locations	Multiple Locations
Israel	Health Corporation of Galilee Medical Center	Nahariya
Israel	Clalit Health Services Schneider Children's Medical Center	Petach Tikva
Israel	Dana-Dwek Children's Hospital	Tel Aviv
Italy	A.O.U. di Bologna Policlinico S.Orsola Malpighi	Bologna	Emilia-Romagna
Italy	IRCCS Istituto Giannina Gaslini	Genova	Liguria
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano	Lombardia
Italy	Many Locations	Multiple Locations
Italy	IRCCS Ospedale Pediatrico Bambino Gesù	Roma	Lazio
Korea, Republic of	Kyungpook National University Hospital	Daegu	Daegu Gwang''yeogsi
Korea, Republic of	Many Locations	Multiple Locations
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggido
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan-si	Gyeongsangnamdo
Lithuania	Hospital of LT University of Health Sciences Kaunas Clinics	Kaunas
Lithuania	Klaipeda Children's Hospital	Klaipeda
Lithuania	Many Locations	Multiple Locations
Lithuania	Vilnius University Hospital Santaros Klinikos Children's Hospital Paediatrics Centre	Vilnius
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	Many Locations	Multiple Locations
Netherlands	University Medical Center Utrecht	Utrecht
Poland	Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa	Bialystok
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Uniwersytecki Szpital Dzieciecy w Krakowie	Krakow
Poland	Instytut Centrum Zdrowia Matki Polki	Lodz
Poland	Many Locations	Multiple Locations
Poland	Instytut "Pomnik - Centrum Zdrowia Dziecka"	Warszawa
Poland	Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu	Wroclaw
Portugal	Centro Clinico Academico Braga | Braga, Portugal	Braga
Portugal	CHULN - H. Sta.Maria (Centro de Investigacao Clinica)	Lisboa
Portugal	Many Locations	Multiple Locations
Portugal	Centro Hospitalar Universitario do Porto	Porto
Spain	Ciutat Sanitaria i Universitaria de la Vall d'Hebron	Barcelona
Spain	Hospital de Sant Joan de Déu	Esplugues de LLobregat	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Regional de Málaga	Málaga
Spain	Many Locations	Multiple Locations
Spain	Virgen del Rocio University Hospital | Pediatric Nephrology Unit	Sevilla
Sweden	Skåne University Hospital	Lund
Sweden	Many Locations	Multiple Locations
Sweden	Karolinska University Hospital	Stockholm
Sweden	Uppsala University Hospital	Uppsala
Switzerland	Universitäts-Kinderspital UKBB	Basel	Basel-Stadt
Switzerland	Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne	Vaud
Switzerland	Many Locations	Multiple Locations
Turkey	Baskent Universitesi Tip Fakultesi Hastanesi	Ankara
Turkey	Gazi Universitesi Tip Fakultesi	Ankara
Turkey	Hacettepe Universitesi Tip Fakultesi	Ankara
Turkey	Health Ministry Of Türkiye Republic Ankara Bilkent City Hospital	Ankara
Turkey	Istanbul Faculty of Medicine, Department of Internal Medicine, Department of Pediatrics	Istanbul
Turkey	Istanbul Universitesi Cerrahpasa-Cocuk Nefrolojisi B. Dali	Istanbul
Turkey	Marmara Uni. Tip Fakultesi Pendik Egitim ve Aras. Hastanesi	Istanbul
Turkey	Many Locations	Multiple Locations
United Kingdom	Birmingham Children's Hospital	Birmingham	West Midlands
United Kingdom	Royal Hospital for Children	Glasgow	Stratchclyde
United Kingdom	Great Ormond Street Hospital for Children	London
United Kingdom	Royal Manchester Children's Hospital	Manchester
United Kingdom	Many Locations	Multiple Locations
United Kingdom	Queens Medical Centre	Nottingham
United States	Emory University Hospital/Children's Healthcare of Atlanta (CHOA)	Atlanta	Georgia
United States	Johns Hopkins Univ School Med|Johns Hopkins Hosp Dept Gyn/Ob	Baltimore	Maryland
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Cincinnati Children's Hospital and Medical Center	Cincinnati	Ohio
United States	Cleveland Clinic | Pediatric Nephrology	Cleveland	Ohio
United States	South Broward Hosp. District dba Memorial Healthcare System	Hollywood	Florida
United States	University of Iowa	Iowa City	Iowa
United States	Children's Mercy Hospital & Clinics	Kansas City	Missouri
United States	University of California San Diego (UCSD)	La Jolla	California
United States	Stanford Medicine	Palo Alto	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Phoenix Children's Hospital | Main - Transplant Department	Phoenix	Arizona
United States	Oregon Health and Science Univ | Doernbecher Childrens Hosp	Portland	Oregon
United States	Primary Children's Hospital	Salt Lake City	Utah
United States	Univ of Texas Health Science Center | Nephrology Res Dept	San Antonio	Texas
United States	Seattle Children's Hospital	Seattle	Washington
United States	Children's Research Institute	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Canada,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Korea, Republic of,  Lithuania,  Netherlands,  Poland,  Portugal,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment emergent adverse event (TEAEs)		Up to 550 days
Primary	Change in serum potassium levels from baseline to Day 540±7		Up to 547 days
Primary	Change in systolic blood pressure (SBP) from baseline to Day 540±7		Up to 547 days
Secondary	Change in urinary protein-to-creatinine ratio (UPCR) from baseline to Day 540±7		Up to 547 days
Secondary	Change in urinary albumin-to-creatinine ratio (UACR) from baseline to Day 540±7		Up to 547 days
Secondary	Change in estimated glomerular filtration rate (eGFR) from baseline to Day 540±7		Up to 547 days

External Links

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