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 (FIONA OLE)

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

Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine.

The kidneys filter waste and fluid from the blood to form urine. In children with CKD, the kidney´s filters do not work as well as they should. This can lead to accumulation of waste and fluid in the body and proteinuria. CKD can lead to other medical problems, such as high blood pressure, also known as hypertension. Vice versa, hypertension and proteinuria can also contribute to worsening of CKD. Therefore, the treatment of CKD aims to control blood pressure and proteinuria. There are treatments available for doctors to prescribe to children with CKD and hypertension and/or proteinuria. These include "angiotensin-converting enzyme inhibitors" (ACEI) and "angiotensin receptor blockers" (ARB). Both ACEI and ARB can help improve kidney function by reducing the activity of the renin-angiotensin-aldosterone system (RAAS). The RAAS is a system that works with the kidneys to control blood pressure and the balance of fluid and electrolytes in the blood. In people with CKD, the RAAS is often too active, which can impair the ability of the kidneys to work properly and cause hypertension and proteinuria. However, ACEI or ARB treatment alone does not work for all patients with CKD as they only target the angiotensin part of the renin-angiotensin-aldosterone system.

The study treatment, finerenone, is expected to help control RAAS overactivation together with an ACEI or ARB.

So, the researchers in this study want to learn more about whether finerenone given in addition to either an ACEI or ARB can help their kidney function.

The main purpose of this study is to learn how safe the treatment is when used of finerenone in addition to an ACEI or ARB in long-term.

To see how safe the treatment is, the study team will collect information on medical problems which are also known as "treatment emergent adverse events" (TEAEs). And they will also collect levels of an electrolyte called potassium in the blood by taking blood samples, and measure blood pressure during the study.

The secondary purpose of this study is to learn how well long-term use of finerenone can reduce the amount of protein in the participants' urine and benefit kidney function when taken with standard of care.

To see how the treatment works, the study team will collect participants' urine samples to assess urinary albumin-to-creatinine ratio (UACR) and urinary protein-to-creatinine ratio (UPCR), which are important assessments for calculating the level of protein in the urine. Researchers will also collect blood samples to analyze serum creatinine and calculate estimated glomerular filtration rate (eGFR). A significant decline in eGFR indicates worsening kidney function.

The study will include participants who had previously participated in FIONA study (NCT05196035). The participants will be aged from 1 year up to 18 years.

The participants will be in the study for approximately 19 months. They will take study treatment for up to 18 months and will be follow up for 1 month. During this period, at least 12 visits are planned for patients who newly start finerenone, and at least 8 visits for patients who already received finerenone.

In the visit, the study team will:

• have their blood pressure, heart rate, temperature, height and weight measured
• have blood and urine samples taken
• have physical examinations
• have their heart examined by an electrocardiogram and echocardiography (a sonogram of the heart)
• answer questions about their medication and whether they have any adverse events, or have their parents or guardian's answer
• answer questions about how they are feeling, or have their parents or guardian's answer
• answer question about how they like the study medication, or have their parents or guardian's answer The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

The doctors will check the participants' health about 30 days after the participants take their last treatment.

Study Overview

• Status: Recruiting
• Conditions: Proteinuria; Chronic Kidney Disease; Children
• Intervention / Treatment: Drug: Finerenone (Kerendia, BAY94-8862)

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 3

Contacts and Locations

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

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1199ABB
    • Recruiting
    • Hospital Italiano de Buenos Aires
  • Buenos Aires, Argentina, C1249ABN
    • Not yet recruiting
    • Hospital de Pediatría Juan P. Garrahan
  • Ciudad Autonoma de Buenos Aire, Argentina, C1270AAN
    • Recruiting
    • Hospital General de Ninos Pedro de Elizalde | Nephrology Department
  • Multiple Locations, Argentina
    • Not yet recruiting
    • Many Locations
  • Buenos Aires
    • La Plata, Buenos Aires, Argentina, 1900
      • Withdrawn
      • Hospital de Niños Sor María Ludovica
  • 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
  • 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
      • Not yet recruiting
      • Clinica de Nefrologia, Urologia y Enfermedades Cardiovascualares | Santa Fe, Argentina
• Australia
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Recruiting
      • Queensland Children's Hospital
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Withdrawn
      • Monash Children's Hospital
    • Parkville, Victoria, Australia, 3052
      • Recruiting
      • Royal Children's Hospital Melbourne
• Austria
  • Multiple Locations, Austria
    • Recruiting
    • Many Locations
  • State of Vienna
    • Vienna, State of Vienna, Austria, 1090
      • Not yet recruiting
      • Uniklinikum Salzburg - Landeskrankenhaus
    • Vienna, State of Vienna, Austria, 1090
      • Not yet recruiting
      • Universitätsklinikum AKH Wien
  • Styria
    • Graz, Styria, Austria, 8036
      • Not yet recruiting
      • Medizinische Universität Graz
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Recruiting
      • Kepler Universitätsklinikum Campus IV
• Belgium
  • Bruxelles - Brussel, Belgium, 1200
    • Not yet recruiting
    • CU Saint-Luc/UZ St-Luc
  • Bruxelles - Brussel, Belgium, 1020
    • Not yet recruiting
    • Huderf / Ukzkf
  • Ghent, Belgium, 9000
    • Recruiting
    • UZ Gent
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Gasthuisberg - Pediatric Nephrology
  • Liège, Belgium, 4000
    • Not yet recruiting
    • CHC Montlégia - Pediatrics
  • Multiple Locations, Belgium
    • Recruiting
    • Many Locations
• Brazil
  • Paraná
    • Curitiba, Paraná, Brazil, 80250-060
      • Not yet recruiting
      • Hospital Pequeno Príncipe
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14051-140
      • Not yet 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
      • Not yet recruiting
      • Instituto da Crianca e do Adolescente
    • São Paulo, São Paulo, Brazil, 30150-221
      • Not yet recruiting
      • Santa Casa de Misericórdia de Belo Horizonte
• Bulgaria
  • Plovdiv Province
    • Plovdiv, Plovdiv Province, Bulgaria, 4002
      • Not yet 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
      • Not yet recruiting
      • Alberta Children's Hospital | Nephrology Clinic
  • Ontario
    • 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
  • Multiple Locations, Czechia
    • Recruiting
    • Many Locations
  • Prague, Czechia, 128 08
    • Recruiting
    • Vseobecna Fakultni Nemocnice V Praze
  • Prague, Czechia, 150 06
    • Recruiting
    • Fakultní nemocnice Motol a Homolka, Pracovište MOTOL
• Denmark
  • Multiple Locations, Denmark
    • Recruiting
    • Many Locations
  • Capital Region
    • Copenhagen, Capital Region, Denmark, 2100
      • Not yet 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
  • Multiple Locations, Finland
    • Recruiting
    • Many Locations
  • Pirkanmaa
    • Tampere, Pirkanmaa, Finland, 33521
      • Recruiting
      • Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS) - Lasten lääketutkimuskeskus PeeTU
  • Southwest Finland
    • Turku, Southwest Finland, Finland, 20520
      • Withdrawn
      • Turun yliopistollinen keskussairaala
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00290
      • Recruiting
      • HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Uusi lastensairaala, nefrologia
• France
  • Multiple Locations, France
    • Recruiting
    • Many Locations
  • Auvergne-Rhône-Alpes
    • Bron, Auvergne-Rhône-Alpes, France, 69677
      • Recruiting
      • CHU de Lyon - Hôpital Femme Mère Enfant
  • Grand Est
    • Strasbourg, Grand Est, France, 67200
      • Not yet recruiting
      • CHU Strasbourg - Hopital Hautepierre
  • New Aquitaine
    • Bordeaux, New Aquitaine, France, 33076
      • Not yet 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
      • Hopital Robert Debre
• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Charité / Pädiatrie
  • Hamburg, Germany, 20246
    • Suspended
    • Universitätsklinikum Hamburg Eppendorf (UKE)
  • Multiple Locations, Germany
    • Recruiting
    • Many Locations
  • Baden-Wurttemberg
    • Heidelberg, Baden-Wurttemberg, Germany, 69115
      • Withdrawn
      • Universitätsklinikum Heidelberg
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Withdrawn
      • Universitätsklinikum Erlangen
  • Lower Saxony
    • Hanover, Lower Saxony, Germany, 30625
      • Withdrawn
      • Medizinische Hochschule Hannover (MHH) | Zentrum Innere Medizin | Klinik fuer Kardiologie und Angiologie
  • North Rhine-Westphalia
    • Bonn, North Rhine-Westphalia, Germany, 53127
      • Withdrawn
      • Kindernierenzentrum Bonn
    • Bonn, North Rhine-Westphalia, Germany, 53127
      • Recruiting
      • Kindernierenzentrum Bonn
    • Essen, North Rhine-Westphalia, Germany, 45147
      • Recruiting
      • Universitätsklinikum Essen
    • Münster, North Rhine-Westphalia, Germany, 48149
      • Withdrawn
      • Universitatsklinikum Munster
• 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
  • Multiple Locations, Greece
    • Recruiting
    • Many Locations
  • Thessaloniki, Greece, 54642
    • Not yet 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
  • Multiple Locations, Hungary
    • Recruiting
    • Many Locations
  • Pécs, Hungary, 7623
    • Recruiting
    • Pecsi Tudomanyegyetem Klinikai Kozpont
  • Szeged, Hungary, 6720
    • Not yet recruiting
    • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 380052
      • Not yet 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- Nephrology Department
  • Jerusalem, Israel, 9103102
    • Not yet recruiting
    • Wilf Children's Hospital Shaare Zedek Medical Center
  • Multiple Locations, Israel
    • Recruiting
    • Many Locations
  • 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
  • Multiple Locations, Italy
    • Recruiting
    • Many Locations
  • 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
      • Recruiting
      • Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Pediatria
  • Lazio
    • Rome, Lazio, Italy, 00165
      • Recruiting
      • Ospedale Pediatrico Bambino Gesù - Nefrologia
  • Liguria
    • Genoa, Liguria, Italy, 16147
      • Recruiting
      • 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
  • Multiple Locations, Lithuania
    • Recruiting
    • Many Locations
  • 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
      • Not yet recruiting
      • Hospital Selayang
    • Subang Jaya, Selangor, Malaysia, 47500
      • Not yet recruiting
      • Sunway Medical Centre
• Mexico
  • Veracruz, Mexico, 91900
    • Not yet recruiting
    • Instituto Veracruzano en Investigación Clinica SC
  • Agguascalientes
    • Aguascalientes, Agguascalientes, Mexico, 20124
      • Not yet recruiting
      • Sitio Alfredo Chew Wong | Aguascalientes, Mexico
  • Mexico City
    • México D.F., Mexico City, Mexico, 6720
      • Not yet recruiting
      • Hospital Infantil de México "Dr. Federico Gómez"
    • México, D.F., Mexico City, Mexico, 4530
      • Not yet recruiting
      • Instituto Nacional de Pediatría
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Not yet recruiting
      • Hospital Universitario "José Eleuterio González"
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • Recruiting
    • Universitair Medisch Centrum Groningen
  • Multiple Locations, Netherlands
    • Not yet recruiting
    • Many Locations
  • Utrecht, Netherlands, 3584 CX
    • Recruiting
    • University Medical Center Utrecht
• 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
  • Multiple Locations, Poland
    • Recruiting
    • Many Locations
  • Warsaw, Poland, 04-730
    • Recruiting
    • Instytut "Pomnik - Centrum Zdrowia Dziecka"
  • Wroclaw, Poland, 50-556
    • Withdrawn
    • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
• Portugal
  • Braga, Portugal, 4710-243
    • Withdrawn
    • Unidade Local de Saúde de Braga E.P.E. - Centro Clínico Académico de Braga - Serviço de Medicina Interna
  • 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
      • Not yet recruiting
      • Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit
• South Korea
  • Multiple Locations, South Korea
    • Recruiting
    • Many Locations
  • Seoul, South Korea, 152-703
    • Not yet recruiting
    • Korea University Guro Hospital
  • 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
• 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
  • Multiple Locations, Spain
    • Recruiting
    • Many Locations
  • Málaga, Spain, 29010
    • Recruiting
    • Hospital Universitario Regional De Malaga | Nefrologia pediatrica
  • Seville, Spain, 41013
    • Completed
    • Hospital Universitario Virgen Del Rocio S.L. | Nefrologia pediatrica
• Sweden
  • Multiple Locations, Sweden
    • Not yet recruiting
    • Many Locations
  • Skåne County
    • Lund, Skåne County, Sweden, 221 85
      • Recruiting
      • Skånes Universitetssjukhus - Lund - Barnnefroenheten
  • Stockholm County
    • Stockholm, Stockholm County, Sweden, 141 86
      • Not yet recruiting
      • Karolinska University Hospital
  • Uppsala County
    • Uppsala, Uppsala County, Sweden, 751 85
      • Withdrawn
      • OBSOLETE_Uppsala University Hospital
• Switzerland
  • Geneva, Switzerland, 1211
    • Recruiting
    • Hopital des Enfants HUG
  • Multiple Locations, Switzerland
    • Recruiting
    • Many Locations
  • 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
    • Not yet recruiting
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 11217
    • Not yet recruiting
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 100229
    • Not yet recruiting
    • National Taiwan University Hospital
  • Taipei, Taiwan, 10507
    • Recruiting
    • Chang Gung Memorial Hospital at Linkou
  • Taoyuan
    • Guishan, Taoyuan, Taiwan, 83301
      • Not yet recruiting
      • Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01790
    • Not yet recruiting
    • Cukurova Univ. Tip. Fak. Balcali Hastanesi
  • Ankara, Turkey (Türkiye), 6490
    • Recruiting
    • Baskent Universitesi Tip Fakultesi Hastanesi
  • Ankara, Turkey (Türkiye), 6560
    • Not yet recruiting
    • Gazi Universitesi Tip Fakultesi
  • Ankara, Turkey (Türkiye), 06230
    • Not yet recruiting
    • Hacettepe 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
  • Multiple Locations, Turkey (Türkiye)
    • Recruiting
    • Many Locations
• United Kingdom
  • Multiple Locations, United Kingdom
    • Recruiting
    • Many Locations
  • 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
      • Withdrawn
      • 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
      • Withdrawn
      • Phoenix Children's Hospital | Main - Transplant Department
  • California
    • Los Angeles, California, United States, 90048
      • Withdrawn
      • Cedars-Sinai Samuel Oschin Cancer Center
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Lucille Packard Children's Hospital Stanford - Pediatric Nephrology
    • San Diego, California, United States, 92123
      • Not yet recruiting
      • Rady Children's Hospital San Diego - Cardiology
  • 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
      • Not yet 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
      • Withdrawn
      • 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
      • Not yet recruiting
      • Children's Mercy Hospital Kansas City - Nephrology
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Not yet recruiting
      • Cincinnati Children's Hospital Medical Center | Division of Nephrology and Hypertension
    • Cleveland, Ohio, United States, 14013
      • Recruiting
      • Cleveland Clinic | Pediatric Nephrology
  • Oregon
    • Portland, Oregon, United States, 97239
      • Not yet 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
      • University Hospital - San Antonio - Pediatric Nephrology
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • Recruiting
      • Eccles Primary Children's Outpatient Services - Nephrology
  • Washington
    • Seattle, Washington, United States, 98105
      • Not yet recruiting
      • Seattle Children's Hospital - Nephrology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Finerenone Open-Label safety Extension; Participants will receive finerenone treatment.	Drug: Finerenone (Kerendia, BAY94-8862); Finerenone in different doses, treatment duration will be 540 ±7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment emergent adverse event (TEAEs)	Up to 550 days
Change in serum potassium levels from baseline to Day 540±7	Up to 547 days
Change in systolic blood pressure (SBP) from baseline to Day 540±7	Up to 547 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in urinary protein-to-creatinine ratio (UPCR) from baseline to Day 540±7	Up to 547 days
Change in urinary albumin-to-creatinine ratio (UACR) from baseline to Day 540±7	Up to 547 days
Change in estimated glomerular filtration rate (eGFR) from baseline to Day 540±7	Up to 547 days

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

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

Study Major Dates

• Study Start (Actual): November 8, 2022
• Primary Completion (Estimated): January 28, 2029
• Study Completion (Estimated): February 27, 2029

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Urination Disorders; Urological Manifestations; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Renal Insufficiency, Chronic; Proteinuria; finerenone
• Other Study ID Numbers: 20186; 2021-002905-89 (EudraCT Number); 2023-504885-50-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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: No