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 (FIONA)

April 16, 2026 updated by: Bayer

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

219

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: For trial location information (Phone Menu Options '3' or '4')
Phone Number: (+)1-888-84 22937

Study Contact Backup

Name: Bayer Clinical Trials Contact
Phone Number: (+) 1-888-84 22937
Email: clinical-trials-contact@bayer.com

Study Locations

Argentina
- - Buenos Aires, Argentina, C1270
    - Recruiting
    - Hospital General de Ninos Pedro de Elizalde | Nephrology Department
  - Buenos Aires, Argentina, C1249ABN
    - Not yet recruiting
    - Hospital de Pediatría Juan P. Garrahan
- Ciudad Auton. de Buenos Aires
  - Ciudad Autonoma de Buenos Aire, Ciudad Auton. de Buenos Aires, Argentina, C1425EFD
    - Recruiting
    - Hospital General de Ninos Ricardo Gutierrez | Pediatric Nephrology Department
  - Ciudad Autonoma de Buenos Aire, Ciudad Auton. de Buenos Aires, Argentina, C1199ABB
    - Recruiting
    - Instituto Universitario Hospital Italiano de Buenos Aires | Hospital Italiano de Buenos Aires - Neurology Department
- San Luis Province
  - San Luis, San Luis Province, Argentina, D5700CGR
    - Recruiting
    - Centro de Rehabilitacion Cardiovascular | San Luis, Argentina
- Santa Fe Province
  - Santa Fe, Santa Fe Province, Argentina, S3000
    - Recruiting
    - Clinica de Nefrologia, Urologia y Enfermedades Cardiovascualares | Santa Fe, Argentina
Australia
- New South Wales
  - Westmead, New South Wales, Australia, 2145
    - Not yet recruiting
    - The Children's Hospital at Westmead
- Queensland
  - South Brisbane, Queensland, Australia, 4101
    - Recruiting
    - Queensland Children's Hospital
- Victoria
  - Clayton, Victoria, Australia, 3168
    - Completed
    - Monash Children's Hospital
  - Parkville, Victoria, Australia, 3052
    - Terminated
    - Royal Children's Hospital Melbourne
Austria
- State of Vienna
  - Vienna, State of Vienna, Austria, 1090
    - Recruiting
    - Uniklinikum Salzburg - Landeskrankenhaus
- Styria
  - Graz, Styria, Austria, 8036
    - Recruiting
    - Medizinische Univ Graz | Kinder & Jugendheilkunde
- Tyrol
  - Innsbruck, Tyrol, Austria, 6020
    - Recruiting
    - Kepler Universitätsklinikum Campus IV
- Vorarlberg
  - Vienna, Vorarlberg, Austria, 6800
    - Recruiting
    - AKH Wien | Kinder & Jugendheilkunde, Kindernephrologie
Belgium
- - Bruxelles - Brussel, Belgium, 1200
    - Recruiting
    - CU Saint-Luc/UZ St-Luc
  - Bruxelles - Brussel, Belgium, 1020
    - Recruiting
    - Huderf / Ukzkf
  - Ghent, Belgium, 9000
    - Recruiting
    - UZ Gent
  - Leuven, Belgium, 3000
    - Recruiting
    - UZ Gasthuisberg - Pediatric Nephrology
  - Liège, Belgium, 4000
    - Recruiting
    - CHC Montlégia - Pediatrics
Brazil
- Paraná
  - Curitiba, Paraná, Brazil, 80250-060
    - Recruiting
    - Hospital Pequeno Principe
- São Paulo
  - Ribeirão Preto, São Paulo, Brazil, 14051-140
    - Recruiting
    - Hosp Clínicas Facult. Med. de Ribeirão Preto / USP
  - São Paulo, São Paulo, Brazil, 01227-200
    - Not yet recruiting
    - Hospital Infantil Sabará - Instituto PENSI - Pesquisa e Ensino em Saúde Infantil
  - São Paulo, São Paulo, Brazil, 13034-685
    - Recruiting
    - Hospital PUC-Campinas | Centro de Pesquisa Clínica Sao Lucas
  - São Paulo, São Paulo, Brazil, 05403 000
    - Recruiting
    - Instituto da Crianca e do Adolescente
  - São Paulo, São Paulo, Brazil, 30150-221
    - Recruiting
    - Santa Casa de Misericordia de Belo Horizonte
Bulgaria
- Plovdiv Province
  - Plovdiv, Plovdiv Province, Bulgaria, 4002
    - Recruiting
    - UMHAT Sveti Georgi
- Sofia City Province
  - Sofia, Sofia City Province, Bulgaria, 1606
    - Not yet recruiting
    - SHATPD "Prof. Ivan Mitev"
- Stara Zagora Province
  - Stara Zagora, Stara Zagora Province, Bulgaria, 6003
    - Withdrawn
    - MHAT prof. Stoyan Kirkovitch AD
Canada
- Alberta
  - Calgary, Alberta, Canada, T3B 6A8
    - Recruiting
    - Alberta Children's Hospital | Nephrology Clinic
- Ontario
  - Hamilton, Ontario, Canada, L8N 3Z5
    - Not yet recruiting
    - McMaster University Medical Centre | McMaster Children's Hospital | Cardiology
  - Toronto, Ontario, Canada, M5G 1X8
    - Not yet recruiting
    - The Hospital for Sick Children (SickKids)
- Quebec
  - Montreal, Quebec, Canada, H3T 1C5
    - Recruiting
    - Centre hospitalier universitaire Sainte-Justine | Cardiology
Czechia
- - Prague, Czechia, 128 08
    - Recruiting
    - Všeobecná fakultní nemocnice v Praze
  - Prague, Czechia, 150 06
    - Recruiting
    - Fakultní nemocnice Motol a Homolka, Pracovište MOTOL
Denmark
- Capital Region
  - Copenhagen, Capital Region, Denmark, 2100
    - Recruiting
    - Rigshospitalet - Børn og Unge
- Central Jutland
  - Aarhus N, Central Jutland, Denmark, 8200
    - Recruiting
    - Aarhus Universitetshospital - Børn og Unge
- Region Syddanmark
  - Odense, Region Syddanmark, Denmark, 5000
    - Recruiting
    - Odense Universitetshospital - HC Andersen Børne og Ungehospital
Finland
- Pirkanmaa
  - Tampere, Pirkanmaa, Finland, 33521
    - Recruiting
    - Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS) - Lasten lääketutkimuskeskus PeeTU
- Southwest Finland
  - Turku, Southwest Finland, Finland, 20520
    - Active, not recruiting
    - Turun yliopistollinen keskussairaala
- Uusimaa
  - Helsinki, Uusimaa, Finland, 00290
    - Recruiting
    - HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Uusi lastensairaala, nefrologia
France
- Auvergne-Rhône-Alpes
  - Bron, Auvergne-Rhône-Alpes, France, 69677
    - Recruiting
    - CHU de Lyon - Hôpital Femme Mère Enfant
- Grand Est
  - Strasbourg, Grand Est, France, 67200
    - Recruiting
    - CHU Strasbourg - Hopital Hautepierre
- New Aquitaine
  - Bordeaux, New Aquitaine, France, 33076
    - Recruiting
    - CHU bordeaux - Hopital Pellegrin
- Occitanie
  - Montpellier, Occitanie, France, 34059
    - Recruiting
    - Hopital Arnaud de Villeneuve CHU Montpellier
  - Toulouse, Occitanie, France, 31059
    - Recruiting
    - Hôpital des Enfants
- Île-de-France Region
  - Paris, Île-de-France Region, France, 75019
    - Recruiting
    - Hôpital Robert Debré
Germany
- - Berlin, Germany, 13353
    - Recruiting
    - Charité / Pädiatrie
  - Hamburg, Germany, 20246
    - Recruiting
    - Universitätsklinikum Hamburg Eppendorf (UKE)
- Baden-Wurttemberg
  - Heidelberg, Baden-Wurttemberg, Germany, 69115
    - Completed
    - Universitätsklinikum Heidelberg
- Bavaria
  - Erlangen, Bavaria, Germany, 91054
    - Not yet recruiting
    - Universitatsklinikum Erlangen
- Lower Saxony
  - Hanover, Lower Saxony, Germany, 30625
    - Active, not recruiting
    - Medizinische Hochschule Hannover (MHH)
- North Rhine-Westphalia
  - Bonn, North Rhine-Westphalia, Germany, 53127
    - Recruiting
    - Kindernierenzentrum Bonn
  - Essen, North Rhine-Westphalia, Germany, 45147
    - Recruiting
    - Universitätsklinikum Essen
  - Münster, North Rhine-Westphalia, Germany, 48149
    - Active, not recruiting
    - Universitätsklinikum Münster
Greece
- - Athens, Greece, 11527
    - Recruiting
    - Children's Hospital of Athens Agia Sofia - Pediatric Nephrology Department
  - Athens, Greece, 11526
    - Recruiting
    - Children's Hospital of Athens P&A Kyriakou - Pediatric Nephrology Department
  - Heraklion, Greece, 71110
    - Recruiting
    - University General Hospital of Heraklion
  - Ioannina, Greece, 45500
    - Recruiting
    - University General Hospital Of Ioannina-Child Health Sector
  - Thessaloniki, Greece, 54642
    - Recruiting
    - Ippokratio General Hospital Of Thessaloniki-Pediatric Nephrology Unit, 3rd Department of Paediatrics
Hungary
- - Budapest, Hungary, 1083
    - Recruiting
    - Semmelweis University
  - Debrecen, Hungary, 4032
    - Recruiting
    - Debreceni Egyetem Klinikai Kozpont
  - Pécs, Hungary, 7623
    - Recruiting
    - Pecsi Tudomanyegyetem Klinikai Kozpont
  - Szeged, Hungary, 6720
    - Recruiting
    - Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
India
- - Chandigarh, India, 160012
    - Withdrawn
    - Post Graduate Institute of Medical education and Research
- Gujarat
  - Ahmedabad, Gujarat, India, 380016
    - Withdrawn
    - Institute of Kidney Diseases and Research Center Gujarat University of Transplantation Sciences
  - Ahmedabad, Gujarat, India, 380052
    - Recruiting
    - Mavani Kidney Care
- Karnataka
  - Bengaluru, Karnataka, India, 560034
    - Recruiting
    - St. John's National Academy of Health Sciences
- National Capital Territory of Delhi
  - Delhi, National Capital Territory of Delhi, India, 110029
    - Recruiting
    - All India Institute of Medical Sciences (AIIMS) - New Delhi
- West Bengal
  - Kolkata, West Bengal, India, 700014
    - Recruiting
    - NRS Medical College
Israel
- - Beersheba, Israel, 8410101
    - Recruiting
    - Clalit Health | Soroka Medical Center - Internal Medicine Department
  - Jerusalem, Israel, 9103102
    - Recruiting
    - Wilf Children's Hospital Shaare Zedek Medical Center
  - Nahariya, Israel, 2210001
    - Recruiting
    - Health Corporation of Galilee Medical Center
  - Petah Tikva, Israel, 4920235
    - Recruiting
    - Clalit Health Services Schneider Children's Medical Center
  - Tel Aviv, Israel, 6423906
    - Recruiting
    - Dana-Dwek Children's Hospital
Italy
- - Florence, Italy, 50139
    - Recruiting
    - Azienda Ospedaliera Universitaria Meyer IRCCS - Nefrologia e Dialisi
  - Torino, Italy, 10126
    - Recruiting
    - A.O.U. Città della Salute e della Scienza di Torino_Regina Margherita - Nefrologia Pediatrica
- Emilia-Romagna
  - Bologna, Emilia-Romagna, Italy, 40138
    - Completed
    - Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Pediatria
- Lazio
  - Rome, Lazio, Italy, 00165
    - Completed
    - Ospedale Pediatrico Bambino Gesù - Nefrologia
- Liguria
  - Genoa, Liguria, Italy, 16147
    - Completed
    - IRCCS Istituto Giannina Gaslini - Nefrologia e Trapianto Rene
- Lombardy
  - Milan, Lombardy, Italy, 20122
    - Recruiting
    - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Nefrologia e Dialisi Pediatrica, Trapianti di Rene
Lithuania
- - Kaunas, Lithuania, LT-50161
    - Recruiting
    - Hospital of LT University of Health Sciences Kaunas Clinics
  - Klaipėda, Lithuania, LT-92140
    - Not yet recruiting
    - Klaipeda Children's Hospital
  - Vilnius, Lithuania, LT-08406
    - Recruiting
    - Vilnius University Hospital Santaros Klinikos Children's Hospital Paediatrics Centre
Malaysia
- Kelantan
  - Kelantan, Kelantan, Malaysia, 16150
    - Recruiting
    - Hospital Universiti Sains Malaysia
- Kuala Lumpur
  - Wilayah Persekutuan Putrajaya, Kuala Lumpur, Malaysia, 50300
    - Recruiting
    - Hospital Tunku Azizah
- Negeri Sembilan
  - Seremban, Negeri Sembilan, Malaysia, 70300
    - Recruiting
    - Hospital Tuanku Ja'afar
- Selangor
  - Shah Alam, Selangor, Malaysia, 68100
    - Recruiting
    - Hospital Selayang
  - Subang Jaya, Selangor, Malaysia, 47500
    - Recruiting
    - Sunway Medical Centre
Mexico
- Agguascalientes
  - Aguascalientes, Agguascalientes, Mexico, 20124
    - Recruiting
    - Sitio Alfredo Chew Wong | Aguascalientes, Mexico
- Mexico City
  - Mexico City, Mexico City, Mexico, 11850
    - Recruiting
    - Instituto Veracruzano en Investigación Clinica SC
  - México D.F., Mexico City, Mexico, 6720
    - Not yet recruiting
    - Hospital Infantil de México "Dr. Federico Gómez"
  - México, D.F., Mexico City, Mexico, 4530
    - Recruiting
    - Instituto Nacional de Pediatría
- Monterrey
  - Nuevo León, Monterrey, Mexico, 64460
    - Not yet recruiting
    - Hospital Universitrio Dr. José Eleuterio González. Servicio de Oncologia
- State of Mexico
  - Ixtapaluca, State of Mexico, Mexico, 56530.
    - Withdrawn
    - Hospital Regional de Alta Especialidad Ixtapaluca
Netherlands
- - Groningen, Netherlands, 9713 GZ
    - Recruiting
    - Universitair Medisch Centrum Groningen
  - Utrecht, Netherlands, 3584 CX
    - Recruiting
    - University Medical Center Utrecht
- Gelderland
  - Nijmegen, Gelderland, Netherlands, 6525 GA
    - Not yet recruiting
    - Universitair Medisch Centrum St. Radboud
Poland
- - Bialystok, Poland, 15-274
    - Recruiting
    - Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa
  - Gdansk, Poland, 80-952
    - Recruiting
    - Uniwersyteckie Centrum Kliniczne
  - Krakow, Poland, 30-663
    - Withdrawn
    - Uniwersytecki Szpital Dzieciecy w Krakowie
  - Lodz, Poland, 93-338
    - Recruiting
    - Instytut Centrum Zdrowia Matki Polki
  - Warsaw, Poland, 04-730
    - Recruiting
    - Instytut "Pomnik - Centrum Zdrowia Dziecka"
  - Warsaw, Poland, 02-091
    - Not yet recruiting
    - Dzieciecy Szpital Kliniczny im. Jozefa Brudzinskiego
  - Wroclaw, Poland, 50-556
    - Withdrawn
    - Uniwersytecki Szpital Kliniczny UM we Wroclawiu
Portugal
- - Braga, Portugal, 4710-243
    - Not yet recruiting
    - Centro Clinico Academico Braga | Braga, Portugal
  - Coimbra, Portugal, 3000
    - Recruiting
    - Hospital Pediátrico de Coimbra I ULS Coimbra
  - Lisbon, Portugal, 1649-035
    - Not yet recruiting
    - Hospital Santa Maria | Centro de Investigacao Clinica
  - Porto, Portugal, 4050-651
    - Recruiting
    - Unidade Local de Saúde de Santo António, E.P.E
South Africa
- Gauteng
  - Soweto, Gauteng, South Africa, 1862
    - Recruiting
    - Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit
South Korea
- Daegu Gwang''yeogsi
  - Daegu, Daegu Gwang''yeogsi, South Korea, 41944
    - Completed
    - Kyungpook National University Hospital
- Gyeonggido
  - Seongnam-si, Gyeonggido, South Korea, 13620
    - Recruiting
    - Seoul National University Bundang Hospital
- Gyeongsangnam-do
  - Yangsan, Gyeongsangnam-do, South Korea, 50612
    - Recruiting
    - Pusan National University Yangsan Hospital
- Seoul Teugbyeolsi
  - Seoul, Seoul Teugbyeolsi, South Korea, 3080
    - Recruiting
    - Seoul National University Hospital
  - Seoul, Seoul Teugbyeolsi, South Korea, 152-703
    - Completed
    - Korea University Guro Hospital
Spain
- - Barcelona, Spain, 08035
    - Recruiting
    - Hospital Universitari Vall D Hebron | Nefrologia pediatrica
  - Barcelona, Spain, 08950
    - Recruiting
    - Hospital Sant Joan De Deu Barcelona | Nefrologia pediatrica
  - Madrid, Spain, 28041
    - Recruiting
    - Hospital Universitario 12 De Octubre | Nefrologia pediatrica
  - Madrid, Spain, 28046
    - Recruiting
    - Hospital Universitario La Paz | Nefrologia pediatrica
  - Málaga, Spain, 29010
    - Recruiting
    - Hospital Universitario Regional De Malaga | Nefrologia pediatrica
  - Seville, Spain, 41013
    - Recruiting
    - Hospital Universitario Virgen Del Rocio S.L. | Nefrologia pediatrica
Sweden
- Skåne County
  - Lund, Skåne County, Sweden, 221 85
    - Recruiting
    - Skånes Universitetssjukhus Lund - Barnnefroenheten
- Stockholm County
  - Stockholm, Stockholm County, Sweden, 141 86
    - Recruiting
    - Karolinska University Hospital
- Uppsala County
  - Uppsala, Uppsala County, Sweden, 751 85
    - Terminated
    - OBSOLETE_Uppsala University Hospital
Switzerland
- - Geneva, Switzerland, 1211
    - Recruiting
    - Hopital des Enfants HUG
- Canton of Basel-City
  - Basel, Canton of Basel-City, Switzerland, 4031
    - Recruiting
    - Universitäts-Kinderspital UKBB
- Canton of Vaud
  - Lausanne, Canton of Vaud, Switzerland, 1012
    - Recruiting
    - Centre Hospitalier Universitaire Vaudois (CHUV)
Taiwan
- - Kaohsiung City, Taiwan, 813414
    - Not yet recruiting
    - Kaohsiung Veterans General Hospital
  - Tainan, Taiwan, 704
    - Recruiting
    - National Cheng Kung University Hospital
  - Taipei, Taiwan, 11217
    - Recruiting
    - Taipei Veterans General Hospital
  - Taipei, Taiwan, 100229
    - Recruiting
    - National Taiwan University Hospital
  - Taipei, Taiwan, 10507
    - Recruiting
    - Chang Gung Memorial Hospital at Linkou
- Taoyuan
  - Guishan, Taoyuan, Taiwan, 83301
    - Recruiting
    - Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch
Turkey (Türkiye)
- - Adana, Turkey (Türkiye), 01790
    - Recruiting
    - Cukurova Univ. Tip. Fak. Balcali Hastanesi
  - Ankara, Turkey (Türkiye), 6490
    - Recruiting
    - Baskent Universitesi Tip Fakultesi Hastanesi
  - Ankara, Turkey (Türkiye), 06230
    - Recruiting
    - Hacettepe Üniversitesi Tip Fakültesi
  - Ankara, Turkey (Türkiye), 6560
    - Recruiting
    - Gazi Universitesi Tip Fakultesi
  - Ankara, Turkey (Türkiye), 6800
    - Recruiting
    - T.C. Saglik Bakanligi Ankara Bilkent Sehir Hastanesi Noroloji ve Ortopedi Hastanesi Noroloji Bolumu
  - Istanbul, Turkey (Türkiye), 34098
    - Recruiting
    - Istanbul Universitesi Cerrahpasa - Cocuk Nefrolojisi
  - Istanbul, Turkey (Türkiye), 34899
    - Recruiting
    - Marmara University Medical Faculty | Pediatric Nephrology
  - Istanbul, Turkey (Türkiye), 34093
    - Recruiting
    - Istanbul Faculty of Medicine, Department of Internal Medicine, Department of Pediatrics
United Kingdom
- Greater London
  - London, Greater London, United Kingdom, WC1N 3JH
    - Recruiting
    - Great Ormond Street Hospital for Children NHS Foundation Trust | Great Ormond Street Hospital - Clinical Research Facility
- Greater Manchester
  - Manchester, Greater Manchester, United Kingdom, M13 9WL
    - Recruiting
    - Manchester University NHS Foundation Trust | Royal Manchester Children's Hospital - Clinical Research Facility
- Nottinghamshire
  - Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
    - Active, not recruiting
    - Nottingham University Hospitals NHS Trust | Queens Medical Centre - Childrens Clinical Research Facility
- Scotland
  - Glasgow, Scotland, United Kingdom, G51 4TF
    - Recruiting
    - NHS Greater Glasgow and Clyde | Royal Hospital for Children - Glasgow Clinical Research Facility
- West Midlands
  - Birmingham, West Midlands, United Kingdom, B4 6NH
    - Not yet recruiting
    - Birmingham Children's Hospital
United States
- Arizona
  - Phoenix, Arizona, United States, 85016
    - Terminated
    - Phoenix Children's Hospital | Main - Transplant Department
- California
  - Los Angeles, California, United States, 90048
    - Withdrawn
    - Cedars-Sinai Medical Center - Nephrology
  - Palo Alto, California, United States, 94304
    - Recruiting
    - Lucille Packard Children's Hospital Stanford - Pediatric Nephrology
  - San Diego, California, United States, 92023
    - Recruiting
    - UC San Diego - Altman Clinical and Translational Research Institute (ACTRI) - Linda Vista Clinic
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20010
    - Not yet recruiting
    - Children's National Hospital - Nephrology
- Florida
  - Hollywood, Florida, United States, 33021
    - Recruiting
    - Memorial Transplant Institute - Pediatric Nephrology
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Withdrawn
    - Emory University Hospital/Children's Healthcare of Atlanta - Nephrology
- Iowa
  - Iowa City, Iowa, United States, 52242
    - Not yet recruiting
    - University of Iowa Health Care Medical Center - Nephrology
- Maryland
  - Baltimore, Maryland, United States, 21287
    - Recruiting
    - The Charlotte R. Bloomberg Children's Center Building - Nephrology
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Withdrawn
    - Boston Children's Hospital - Main Campus - Nephrology
- Missouri
  - Kansas City, Missouri, United States, 64108
    - Recruiting
    - Children's Mercy Hospital Kansas City - Nephrology
- Ohio
  - Cincinnati, Ohio, United States, 45229
    - Recruiting
    - Cincinnati Children's Hospital Medical Center | Division of Nephrology and Hypertension
  - Cleveland, Ohio, United States, 14013
    - Recruiting
    - Cleveland Clinic | Pediatric Nephrology
  - Columbus, Ohio, United States, 43205
    - Not yet recruiting
    - Nationwide Children's Hospital - Nephrology
- Oregon
  - Portland, Oregon, United States, 97239
    - Recruiting
    - OHSU Doernbecher Children's Hospital - Neurology
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104
    - Not yet recruiting
    - Children's Hospital of Philadelphia - Nephrology
- Texas
  - San Antonio, Texas, United States, 78207
    - Withdrawn
    - Univ of Texas Health Science Center | Nephrology Res Dept
- Utah
  - Salt Lake City, Utah, United States, 84113
    - Recruiting
    - Eccles Primary Children's Outpatient Services - Nephrology
- Washington
  - Seattle, Washington, United States, 98105
    - Recruiting
    - Seattle Children's Hospital - Nephrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 17 years (Child)

Accepts Healthy Volunteers

Description

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:
- 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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Finerenone (Kerendia, BAY94-8862) Participants will receive finerenone treatment.	Drug: Finerenone (Kerendia, BAY94-8862) Finerenone in different doses, treatment duration will be 180±7 days
Placebo Comparator: Placebo Participants will receive placebo to finerenone.	Drug: Placebo Placebo to finerenone, treatment duration will be 180±7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in Urinary protein-to-creatinine ratio (UPCR) reduction from baseline to day 180+/-7 Time Frame: From baseline to day 180+/-7	Percent change from baseline to day 180±7 in UPCR will be calculated.	From baseline to day 180+/-7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number participants with treatment emergent adverse events (TEAEs） Time Frame: From the start of study intervention to last study intervention + 3 days (up to 190 days)	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)
Change in serum potassium levels from baseline to day 180±7 Time Frame: From baseline to day 180±7		From baseline to day 180±7
Change in serum creatinine from baseline to day 180±7 Time Frame: From baseline to day 180±7		From baseline to day 180±7
Change in eGFR from baseline to day 180±7 Time Frame: From baseline to day 180±7	Estimated glomerular filtration rate (eGFR)	From baseline to day 180±7
Change in systolic blood pressure from baseline to day 180±7 Time Frame: From baseline to day 180±7		From baseline to day 180±7
Change in UACR from baseline to day 180±7 Time Frame: From baseline to day 180±7	Urinary albumin-to-creatinine ratio (UACR)	From baseline to day 180±7
Pharmacokinetics (PK) finerenone Cmax, md Time Frame: Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 180±7	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
Pharmacokinetics (PK) finerenone AUCτ,md Time Frame: Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 180±7	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
Taste and texture questionnaire of the pediatric formulation Time Frame: On day 30±3 and day 180±7		On day 30±3 and day 180±7
UPCR reduction of at least 30% from baseline to day 180+/-7 Time Frame: From baseline to day 180±7	Proportion of participants at day 180+/-7 with a >=30% reduction in PUCR compared to baseline	From baseline to day 180±7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Helpful Links

Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2022

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

January 7, 2022

First Submitted That Met QC Criteria

January 7, 2022

First Posted (Actual)

January 19, 2022

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

19920
2021-002071-19 (EudraCT Number)
2023-504884-17-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Proteinuria

Clinical Trials on Finerenone (Kerendia, BAY94-8862)

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