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
NCT ID: NCT05196035
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
219 participants
INTERVENTIONAL
2022-03-28
2027-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Finerenone (Kerendia, BAY94-8862)
Participants will receive finerenone treatment.
Finerenone (Kerendia, BAY94-8862)
Finerenone in different doses, treatment duration will be 180±7 days
Placebo
Participants will receive placebo to finerenone.
Placebo
Placebo to finerenone, treatment duration will be 180±7 days
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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:
* For participants with a creatinine of \> 0.8 mg/dL at screening: no increase or decrease in eGFR by ≥ 20% at D0
* For participants with a creatinine of ≤ 0.8 mg/dL at screening: no increase or decrease in creatinine ≥ 0.15 mg/dL at D0.
* 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
* 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
6 Months
17 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Phoenix Children's Hospital | Main - Transplant Department
Phoenix, Arizona, United States
Cedars-Sinai Medical Center - Nephrology
Los Angeles, California, United States
Lucille Packard Children's Hospital Stanford - Pediatric Nephrology
Palo Alto, California, United States
Rady Children's Hospital San Diego - Cardiology
San Diego, California, United States
Children's National Hospital - Nephrology
Washington D.C., District of Columbia, United States
Memorial Transplant Institute - Pediatric Nephrology
Hollywood, Florida, United States
Emory University Hospital/Children's Healthcare of Atlanta - Nephrology
Atlanta, Georgia, United States
University of Iowa Health Care Medical Center - Nephrology
Iowa City, Iowa, United States
The Charlotte R. Bloomberg Children's Center Building - Nephrology
Baltimore, Maryland, United States
Boston Children's Hospital - Main Campus - Nephrology
Boston, Massachusetts, United States
Children's Mercy Hospital Kansas City - Nephrology
Kansas City, Missouri, United States
Cincinnati Children's Hospital Medical Center | Division of Nephrology and Hypertension
Cincinnati, Ohio, United States
Cleveland Clinic | Pediatric Nephrology
Cleveland, Ohio, United States
Nationwide Children's Hospital - Nephrology
Columbus, Ohio, United States
OHSU Doernbecher Children's Hospital - Neurology
Portland, Oregon, United States
Children's Hospital of Philadelphia - Nephrology
Philadelphia, Pennsylvania, United States
Univ of Texas Health Science Center | Nephrology Res Dept
San Antonio, Texas, United States
Eccles Primary Children's Outpatient Services - Nephrology
Salt Lake City, Utah, United States
Seattle Children's Hospital - Nephrology
Seattle, Washington, United States
Instituto Universitario Hospital Italiano de Buenos Aires | Hospital Italiano de Buenos Aires - Neurology Department
Ciudad Autonoma de Buenos Aire, Ciudad Auton. de Buenos Aires, Argentina
Hospital General de Ninos Ricardo Gutierrez | Pediatric Nephrology Department
Ciudad Autonoma de Buenos Aire, Ciudad Auton. de Buenos Aires, Argentina
Centro de Rehabilitacion Cardiovascular | San Luis, Argentina
San Luis, San Luis Province, Argentina
Clinica de Nefrologia, Urologia y Enfermedades Cardiovascualares | Santa Fe, Argentina
Santa Fe, Santa Fe Province, Argentina
Hospital de Pediatría Juan P. Garrahan
Buenos Aires, , Argentina
Hospital General de Ninos Pedro de Elizalde | Nephrology Department
Buenos Aires, , Argentina
The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Queensland Children's Hospital
South Brisbane, Queensland, Australia
Monash Children's Hospital
Clayton, Victoria, Australia
Royal Children's Hospital Melbourne
Parkville, Victoria, Australia
Medizinische Univ Graz | Kinder & Jugendheilkunde
Graz, Styria, Austria
Kepler Universitätsklinikum Campus IV
Linz, Upper Austria, Austria
Uniklinikum Salzburg - Landeskrankenhaus
Salzburg, , Austria
AKH Wien | Kinder & Jugendheilkunde, Kindernephrologie
Vienna, , Austria
Huderf / Ukzkf
Bruxelles - Brussel, , Belgium
CU Saint-Luc/UZ St-Luc
Bruxelles - Brussel, , Belgium
UZ Gent
Ghent, , Belgium
UZ Gasthuisberg - Pediatric Nephrology
Leuven, , Belgium
CHC Montlégia - Pediatrics
Liège, , Belgium
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
Hospital Pequeno Principe
Curitiba, Paraná, Brazil
Hosp Clínicas Facult. Med. de Ribeirão Preto / USP
Ribeirão Preto/SP, São Paulo, Brazil
Hospital Infantil Sabará - Instituto PENSI - Pesquisa e Ensino em Saúde Infantil
São Paulo, São Paulo, Brazil
Hospital PUC-Campinas | Centro de Pesquisa Clínica Sao Lucas
São Paulo, São Paulo, Brazil
Instituto da Crianca e do Adolescente
São Paulo, , Brazil
UMHAT Sveti Georgi
Plovdiv, , Bulgaria
SHATPD "Prof. Ivan Mitev"
Sofia, , Bulgaria
MHAT prof. Stoyan Kirkovitch AD
Stara Zagora, , Bulgaria
Alberta Children's Hospital - Nephrology Clinic
Calgary, Alberta, Canada
McMaster Children's Hospital
Hamilton, Ontario, Canada
The Hospital for Sick Children (SickKids)
Toronto, Ontario, Canada
CHU Sainte-Justine
Montreal, Quebec, Canada
Všeobecná fakultní nemocnice v Praze
Prague, , Czechia
Fakultní nemocnice Motol a Homolka, Pracovište MOTOL
Prague, , Czechia
Aarhus Universitetshospital - Børn og Unge
Århus N, , Denmark
Rigshospitalet - Børn og Unge
Copenhagen, , Denmark
Odense Universitetshospital - HC Andersen Børne og Ungehospital
Odense C, , Denmark
HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Uusi lastensairaala, nefrologia
Helsinki, , Finland
Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS) - Lasten lääketutkimuskeskus PeeTU
Tampere, , Finland
Turun yliopistollinen keskussairaala
Turku, , Finland
CHU bordeaux - Hopital Pellegrin
Bordeaux, , France
CHU de Lyon - Hopital Femme Mère Enfant
Bron, , France
Hopital Arnaud de Villeneuve CHU Montpellier
Montpellier, , France
Hopital Robert Debre
Paris, , France
CHU Strasbourg - Hopital Hautepierre
Strasbourg, , France
Hôpital des Enfants
Toulouse, , France
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany
Medizinische Hochschule Hannover (MHH)
Hanover, Lower Saxony, Germany
Kindernierenzentrum Bonn
Bonn, North Rhine-Westphalia, Germany
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany
Charité / Pädiatrie
Berlin, , Germany
Universitätsklinikum Hamburg Eppendorf (UKE)
Hamburg, , Germany
Children's Hospital of Athens P&A Kyriakou - Pediatric Nephrology Department
Athens, , Greece
Children's Hospital of Athens Agia Sofia - Pediatric Nephrology Department
Athens, , Greece
University General Hospital of Heraklion - Department of Paediatrics
Heraklion, , Greece
University General Hospital Of Ioannina-Child Health Sector
Ioannina, , Greece
Ippokratio General Hospital Of Thessaloniki-Pediatric Nephrology Unit, 3rd Department of Paediatrics
Thessaloniki, , Greece
Semmelweis University
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, , Hungary
SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
Szeged, , Hungary
Institute of Kidney Diseases and Research Center Gujarat University of Transplantation Sciences
Ahmedabad, , India
Mavani Kidney Care
Ahmedabad, , India
St. John's National Academy of Health Sciences
Bangalore, , India
Post Graduate Institute of Medical Education and Research
Chandigarh, , India
All India Institute of Medical Sciences (AIIMS) - New Delhi
Delhi, , India
NRS Medical college
Kolkata, , India
Clalit Health | Soroka Medical Center - Internal Medicine Department
Beersheba, , Israel
Wilf Children's Hospital Shaare Zedek Medical Center
Jerusalem, , Israel
Health Corporation of Galilee Medical Center
Nahariya, , Israel
Clalit Health Services Schneider Children's Medical Center
Petah Tikva, , Israel
Dana-Dwek Children's Hospital
Tel Aviv, , Israel
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Pediatria
Bologna, Emilia-Romagna, Italy
Ospedale Pediatrico Bambino Gesù - Nefrologia
Rome, Lazio, Italy
IRCCS Istituto Giannina Gaslini - Nefrologia e Trapianto Rene
Genoa, Liguria, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Nefrologia e Dialisi Pediatrica, Trapianti di Rene
Milan, Lombardy, Italy
Azienda Ospedaliera Universitaria Meyer IRCCS - Nefrologia e Dialisi
Florence, , Italy
A.O.U. Città della Salute e della Scienza di Torino_Regina Margherita - Nefrologia Pediatrica
Torino, , Italy
Hospital of LT University of Health Sciences Kaunas Clinics
Kaunas, , Lithuania
Klaipeda Children's Hospital
Klaipėda, , Lithuania
Vilnius University Hospital Santaros Klinikos Children's Hospital Paediatrics Centre
Vilnius, , Lithuania
Hospital Tunku Azizah
Wilayah Persekutuan, Kuala Lumpur, Malaysia
Hospital Tuanku Ja'afar
Seremban, Negeri Sembilan, Malaysia
Hospital Selayang
Shah Alam, Selangor, Malaysia
Sunway Medical Centre
Subang Jaya, Selangor, Malaysia
Hospital Universiti Sains Malaysia
Kelantan, , Malaysia
Sitio Alfredo Chew Wong | Aguascalientes, Mexico
Aguascalientes, Agguascalientes, Mexico
Instituto Veracruzano en Investigación Clinica SC
Mexico City, Mexico City, Mexico
Hospital Infantil de México "Dr. Federico Gómez"
México D.F., Mexico City, Mexico
Instituto Nacional de Pediatría
México, D.F., Mexico City, Mexico
Hospital Universitrio Dr. José Eleuterio González. Servicio de Oncologia
Nuevo León, Monterrey, Mexico
Hospital Regional de Alta Especialidad Ixtapaluca
Ixtapaluca, State of Mexico, Mexico
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Universitair Medisch Centrum St. Radboud
Nijmegen, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
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
Dzieciecy Szpital Kliniczny im. Jozefa Brudzinskiego
Warsaw, , Poland
Instytut "Pomnik - Centrum Zdrowia Dziecka"
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny UM we Wroclawiu
Wroclaw, , Poland
Hospital Santa Maria | Centro de Investigacao Clinica
Missing, Lisbon District, Portugal
Centro Clinico Academico Braga | Braga, Portugal
Braga, , Portugal
Hospital Pediátrico de Coimbra I ULS Coimbra
Coimbra, , Portugal
Unidade Local de Saúde de Santo António, E.P.E
Porto, , Portugal
Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit
Soweto, Gauteng, South Africa
Kyungpook National University Hospital
Daegu, Daegu Gwang''yeogsi, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, South Korea
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea
Korea University Guro Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Hospital Universitari Vall D Hebron | Nefrologia pediatrica
Barcelona, , Spain
Hospital Sant Joan De Deu Barcelona | Nefrologia pediatrica
Barcelona, , Spain
Hospital Universitario 12 De Octubre | Nefrologia pediatrica
Madrid, , Spain
Hospital Universitario La Paz | Nefrologia pediatrica
Madrid, , Spain
Hospital Universitario Regional De Malaga | Nefrologia pediatrica
Málaga, , Spain
Hospital Universitario Virgen Del Rocio S.L. | Nefrologia pediatrica
Seville, , Spain
Skånes Universitetssjukhus Lund - Barnnefroenheten
Lund, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Universitäts-Kinderspital UKBB
Basel, Canton of Basel-City, Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland
Hopital des Enfants HUG
Geneva, , Switzerland
National Cheng Kung University Hospital
Tainan, TNN, Taiwan
Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch
Guishan, , Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital at Linkou
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Cukurova Univ. Tip. Fak. Balcali Hastanesi
Adana, , Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi
Ankara, , Turkey (Türkiye)
Baskent Universitesi Tip Fakultesi Hastanesi
Ankara, , Turkey (Türkiye)
Gazi Universitesi Tip Fakultesi
Ankara, , Turkey (Türkiye)
T.C. Saglik Bakanligi Ankara Bilkent Sehir Hastanesi Noroloji ve Ortopedi Hastanesi Noroloji Bolumu
Ankara, , Turkey (Türkiye)
Istanbul Faculty of Medicine, Department of Internal Medicine, Department of Pediatrics
Istanbul, , Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa - Cocuk Nefrolojisi
Istanbul, , Turkey (Türkiye)
Marmara University Medical Faculty | Pediatric Nephrology
Istanbul, , Turkey (Türkiye)
Manchester University NHS Foundation Trust | Royal Manchester Children's Hospital - Clinical Research Facility
Manchester, Greater Manchester, United Kingdom
Nottingham University Hospitals NHS Trust | Queens Medical Centre - Childrens Clinical Research Facility
Nottingham, Nottinghamshire, United Kingdom
NHS Greater Glasgow and Clyde | Royal Hospital for Children - Glasgow Clinical Research Facility
Glasgow, Scotland, United Kingdom
Birmingham Children's Hospital
Birmingham, West Midlands, United Kingdom
Great Ormond Street Hospital for Children NHS Foundation Trust | Great Ormond Street Hospital - Clinical Research Facility
London, , United Kingdom
Countries
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Central Contacts
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For trial location information (Phone Menu Options '3' or '4')
Role: CONTACT
References
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Schaefer F, Montini G, Kang HG, Walle JV, Zaritsky J, Schreuder MF, Litwin M, Scalise A, Scott H, Potts J, Iveli P, Breitenstein S, Warady BA. Investigating the use of finerenone in children with chronic kidney disease and proteinuria: design of the FIONA and open-label extension studies. Trials. 2024 Mar 21;25(1):203. doi: 10.1186/s13063-024-08021-z.
Related Links
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Other Identifiers
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2023-504884-17-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-002071-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
19920
Identifier Type: -
Identifier Source: org_study_id
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