A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria

Chronic Kidney Disease Clinical Trial

— FIONA  

Official title:

A 6-month Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and PK/PD of an age-and Body Weight-adjusted Oral Finerenone Regimen, in Addition to an ACEI or ARB, for the Treatment of Children, 6 Months to <18 Years of Age, With Chronic Kidney Disease and Proteinuria

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05196035
• Other study ID #: 19920
• Secondary ID: 2023-504884-17-0
• Status: Recruiting
• Phase: Phase 3
• Start date: March 28, 2022
• Est. completion date: March 11, 2027

Study information

• Verified date: March 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 improve kidney function by helping the renin-angiotensin-aldosterone system (RAAS) to work normally. 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 stop the kidneys from working 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 more about whether finerenone added to either ACEI or ARB can help reduce the amount of protein in the participants' urine more than a placebo. A placebo looks like a treatment but does not have any medicine in it. Participants will also continue to receive their other medications. To see how the treatment work, the doctors will take samples of the participants' urine to measure their protein levels before and during taking treatment and after their last treatment. In addition, blood samples will be taken to monitor kidney function, electrolytes and the amount of finerenone in the blood as well as for other tests. This study will include children with CKD and proteinuria aged from 6 months up to less than 18 years. The participants will take: - either finerenone or the placebo, in addition to - either ACEI or ARB, whichever they take as part of their normal treatment Two visits are required up to 104 days, to check whether a child can take part in the treatment phase of the study. If participants qualify for the treatment phase, they will then undergo treatment for about 180 days. During this time, they will visit the study site at least 7 times. During these visits, the participants 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 guardians answer - answer questions about how they are feeling, or have their parents or guardians answer - answer question about how they like the study medication, or have their parents or guardians 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: 219
• Est. completion date: March 11, 2027
• Est. primary completion date: February 11, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 17 Years

Eligibility

Inclusion Criteria:

• Participants must be 6 months to <18 years old at the time when the informed consent/assent is signed
• Participants must have a clinical diagnosis of chronic kidney disease (CKD) at screening which is defined as
• CKD stages 1-3 (eGFR =30 mL/min/1.73m^2) for children =1 year to <18 years of age or
• a serum creatinine = 0.40 mg/dL for infants 6 months to < 1 year of age and
• severely increased proteinuria as defined by
• Urinary protein-to-creatinine ratio (UPCR) of = 0.50 g/g in participants = 2 years with CKD stage 2 and 3 or
• UPCR = 1.0 g/g for patients < 2 years of age or = 2 years of age and with CKD stage 1
• Participants must have stable kidney function between screening and D0 defined as:
• no increase or decrease in eGFR = 15% for children =1 year or
• no increase or decrease in creatinine = 0.10 mg/dL for children <1 year
• 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 management, unchanged for at least 30 days prior to screening
• K+ =5.0 mmol/L for children =2 years of age at both screening and D0, and =5.3 mmol/L for children <2 years of age at both screening and D0

Exclusion Criteria:

• Planned urological surgery expected to influence renal function
• Children with hemolytic uremic syndrome (HUS) diagnosed =6 months prior to screening
• Patients with nephrotic syndrome receiving albumin infusions within the last 6 months prior to screening
• Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame
• Renal allograft in place
• Bilateral renal artery stenosis
• Acute kidney injury requiring dialysis within 6 months prior to screening
• Systemic hypertension stage 2 in children =1 year of age defined according to guidelines on blood pressure management at screening or randomization
• Systolic blood pressure (SBP) above 110 mmHg in infants 6 months to <1 year of age at screening or randomization
• Systemic hypotension defined as a systolic blood pressure below the 5th percentile for age, sex and height at either screening or randomization but no lower than 80 mmHg (although for some participants the 5th percentile of SBP is < 80 mmHg they must be excluded if their SBP is <80 mmHg)
• Participants with immune-mediated CKD using rituximab, cyclophosphamide, abatacept, or high-dose glucocorticoids, within <6 months prior to screening

Related Conditions & MeSH terms

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

Intervention

Drug:
• Finerenone (Kerendia, BAY94-8862)
Finerenone in different doses, treatment duration will be 180±7 days
• Placebo
Placebo to finerenone, treatment duration will be 180±7 days

Locations

Country	Name	City	State
Argentina	Hospital de Niños "Ricardo Gutiérrez"	Buenos Aires	Ciudad Auton. De Buenos Aires
Argentina	Hospital Italiano Buenos Aires	Buenos Aires	Ciudad Auton. De Buenos Aires
Argentina	Hospital General de Niños Pedro de Elizalde	Ciudad de Buenos Aires
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
Australia	The Children's Hospital at Westmead	Westmead	New South Wales
Austria	Medizinische Univ Graz | Kinder & Jugendheilkunde	Graz	Steiermark
Austria	Kepler Universitätsklinikum Campus IV	Linz	Oberösterreich
Austria	Many Locations	Multiple Locations
Austria	Uniklinikum Salzburg - Landeskrankenhaus	Salzburg
Austria	AKH Wien | Kinder & Jugendheilkunde, Kindernephrologie	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
China	Many Locations	Multiple Locations
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 cedex
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	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	Korea University Guro Hospital	Seoul	Seoul Teugbyeolsi
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	Universitair Medisch Centrum St. Radboud	Nijmegen
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	Dzieciecy Szpital Kliniczny im. Jozefa Brudzinskiego	Warszawa
Poland	Instytut "Pomnik - Centrum Zdrowia Dziecka"	Warszawa
Poland	Uniwersytecki Szpital Kliniczny UM 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	H Univ. 12 de Octubre | Unidad Pediátrica Inv y EECC (UPIC)	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	Hopital des Enfants HUG	Geneva
Switzerland	Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne	Vaud
Switzerland	Many Locations	Multiple Locations
Turkey	Cukurova Univ. Tip. Fak. Balcali Hastanesi	Adana
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
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	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	Nationwide Children's Hospital	Columbus	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	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

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Canada,  China,  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	Urinary protein-to-creatinine ratio (UPCR) reduction of at least 30% from baseline to day 180±7	Proportion of participants at day 180±7 with a >=30% reduction in UPCR compared to baseline.	From baseline to day 180±7
Secondary	Number participants with treatment emergent adverse events (TEAEs)	Below sub-categories will be considered: Serious Treatment Emergent Adverse Events (TEAEs); TEAEs and serious TEAEs leading to discontinuation of treatment; Study drug related TEAEs and serious TEAEs; TEAEs categorized by severity (mild, moderate, severe); TEAEs by maximum intensity; Number of participants hospitalized with hyperkalemia,; Number of participants discontinuing due to hyperkalemia,; Number of participants with hospitalization for worsening of renal function; Number of participants discontinuing due to worsening of renal function	From the start of study intervention to last study intervention + 3 days (up to 190 days)
Secondary	Change in serum potassium levels from baseline to day 180±7		From baseline to day 180±7
Secondary	Change in serum creatinine from baseline to day 180±7		From baseline to day 180±7
Secondary	Change in eGFR from baseline to day 180±7	Estimated glomerular filtration rate (eGFR)	From baseline to day 180±7
Secondary	Change in systolic blood pressure from baseline to day 180±7		From baseline to day 180±7
Secondary	Mean reduction from baseline to day 180±7 in UPCR	Percent change from baseline to day 180±7 in UPCR will be calculated.	From baseline to day 180±7
Secondary	Change in UACR from baseline to day 180±7	Urinary albumin-to-creatinine ratio (UACR)	From baseline to day 180±7
Secondary	Pharmacokinetics (PK) finerenone Cmax, md	Maximum observed finerenone concentration in plasma after multiple doses.	Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 180±7
Secondary	Pharmacokinetics (PK) finerenone AUCt,md	Area under the curve for finerenone concentration in plasma after multiple doses.	Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 180±7
Secondary	Taste and texture questionnaire of the pediatric formulation		On day 30±3 and day 180±7

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