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Clinical Trial Details

Trial ID: L0438
Source ID: NCT05196035
Associated Drug: Finerenone (Kerendia, Bay94-8862)
Title: 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
Acronym: FIONA
Status: RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Disease|Proteinuria
Interventions: DRUG: Finerenone (Kerendia, BAY94-8862)|DRUG: Placebo
Outcome Measures: Primary: Urinary protein-to-creatinine ratio (UPCR) reduction of at least 30% from baseline to day 180±7, Proportion of participants at day 180±7 with a \>=30% reduction in UPCR compared to baseline., From baseline to day 180±7 | Secondary: Number participants with treatment emergent adverse events (TEAEs）, Below sub-categories will be considered: 1. Serious Treatment Emergent Adverse Events (TEAEs) 2. TEAEs and serious TEAEs leading to discontinuation of treatment 3. Study drug related TEAEs and serious TEAEs 4. TEAEs categorized by severity (mild, moderate, severe) 5. TEAEs by maximum intensity 6. Number of participants hospitalized with hyperkalemia, 7. Number of participants discontinuing due to hyperkalemia, 8. Number of participants with hospitalization for worsening of renal function 9. 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, From baseline to day 180±7|Change in serum creatinine from baseline to day 180±7, From baseline to day 180±7|Change in eGFR 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, From baseline to day 180±7|Mean reduction from baseline to day 180±7 in UPCR, Percent change from baseline to day 180±7 in UPCR will be calculated., From baseline to day 180±7|Change in UACR from baseline to day 180±7, Urinary albumin-to-creatinine ratio (UACR), From baseline to day 180±7|Pharmacokinetics (PK) finerenone Cmax, md, Maximum observed finerenone concentration in plasma after multiple doses., Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 180±7|Pharmacokinetics (PK) finerenone AUCτ,md, Area under the curve for finerenone concentration in plasma after multiple doses., Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 180±7|Taste and texture questionnaire of the pediatric formulation, On day 30±3 and day 180±7
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: CHILD
Phases: PHASE3
Enrollment: 219
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-03-28
Completion Date: 2027-08-31
Results First Posted:
Last Update Posted: 2025-04-13
Locations: Phoenix Children's Hospital | Main - Transplant Department, Phoenix, Arizona, 85016, United States|University of California San Diego (UCSD), La Jolla, California, 92093, United States|Lucille Packard Children's Hospital Stanford - Pediatric Nephrology, Palo Alto, California, 94304, United States|Children's National Medical Center - Nephrology, Washington, District of Columbia, 20010, United States|South Broward Hosp. District dba Memorial Healthcare System, Hollywood, Florida, 33021, United States|Emory University Hospital/Children's Healthcare of Atlanta - Nephrology, Atlanta, Georgia, 30322, United States|University of Iowa, Iowa City, Iowa, 52242, United States|The Charlotte R. Bloomberg Children's Center Building - Nephrology, Baltimore, Maryland, 21287, United States|Boston Children's Hospital - Main Campus - Nephrology, Boston, Massachusetts, 02115, United States|Children's Mercy Hospital Kansas City - Nephrology, Kansas City, Missouri, 64108, United States|Cincinnati Children's Hospital Medical Center | Division of Nephrology and Hypertension, Cincinnati, Ohio, 45229, United States|Cleveland Clinic | Pediatric Nephrology, Cleveland, Ohio, 14013, United States|Nationwide Children's Hospital - Nephrology, Columbus, Ohio, 43205, United States|Oregon Health and Science Univ | Doernbecher Childrens Hosp, Portland, Oregon, 97239, United States|Children's Hospital of Philadelphia - Nephrology, Philadelphia, Pennsylvania, 19104, United States|Univ of Texas Health Science Center | Nephrology Res Dept, San Antonio, Texas, 78207, United States|Primary Children's Hospital, Salt Lake City, Utah, 84113, United States|Seattle Children's Hospital, Seattle, Washington, 98105, 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, C1199ABB, Argentina|Hospital General de Ninos Ricardo Gutierrez | Pediatric Nephrology Department, Ciudad Autonoma de Buenos Aire, Ciudad Auton. De Buenos Aires, C1425EFD, Argentina|Centro de Rehabilitacion Cardiovascular | San Luis, Argentina, San Luis, Provincia De San Luis, D5700CGR, Argentina|Clinica de Nefrologia, Urologia y Enfermedades Cardiovascualares | Santa Fe, Argentina, Santa Fe, Provincia De Santa Fe, S3000, Argentina|Hospital de Pediatría Juan P. Garrahan, Buenos Aires, C1249ABN, Argentina|Hospital General de Ninos Pedro de Elizalde | Nephrology Department, Buenos Aires, C1270, Argentina|The Children's Hospital at Westmead, Westmead, New South Wales, 2145, Australia|Queensland Children's Hospital, South Brisbane, Queensland, 4101, Australia|Monash Children's Hospital, Clayton, Victoria, 3168, Australia|Royal Children's Hospital Melbourne, Parkville, Victoria, 3052, Australia|Kepler Universitätsklinikum Campus IV, Linz, Oberösterreich, 4020, Austria|Medizinische Univ Graz | Kinder & Jugendheilkunde, Graz, Steiermark, 8036, Austria|Uniklinikum Salzburg - Landeskrankenhaus, Salzburg, 5020, Austria|AKH Wien | Kinder & Jugendheilkunde, Kindernephrologie, Wien, 1090, Austria|Huderf / Ukzkf, Bruxelles - Brussel, 1020, Belgium|CU Saint-Luc/UZ St-Luc, Bruxelles - Brussel, 1200, Belgium|UZ Gent, Gent, 9000, Belgium|UZ Gasthuisberg - Pediatric Nephrology, Leuven, 3000, Belgium|CHC Montlégia - Pediatrics, Liège, 4000, Belgium|Santa Casa de Misericórdia de Belo Horizonte, Belo Horizonte, Minas Gerais, 30150-221, Brazil|Hospital Pequeno Principe, Curitiba, Parana, 80250-060, Brazil|Hosp Clínicas Facult. Med. de Ribeirão Preto / USP, Ribeirão Preto/SP, Sao Paulo, 14051-140, Brazil|Hospital PUC-Campinas | Centro de Pesquisa Clínica Sao Lucas, São Paulo, Sao Paulo, 13034-685, Brazil|Hospital Infantil Sabará - Instituto PENSI - Pesquisa e Ensino em Saúde Infantil, Sao Paulo, SP, 01227-200, Brazil|Instituto da Crianca e do Adolescente, Sao Paulo, 05403 000, Brazil|UMHAT Sveti Georgi, Plovdiv, 4002, Bulgaria|SHATPD "Prof. Ivan Mitev", Sofia, 1606, Bulgaria|MHAT prof. Stoyan Kirkovitch AD, Stara Zagora, 6003, Bulgaria|Alberta Children's Hospital - Nephrology Clinic, Calgary, Alberta, T3B 6A8, Canada|McMaster Children's Hospital, Hamilton, Ontario, L8N 3Z5, Canada|The Hospital for Sick Children (SickKids), Toronto, Ontario, M5G 1X8, Canada|CHU Sainte-Justine, Montreal, Quebec, H3T 1C5, Canada|Všeobecná fakultní nemocnice v Praze, Praha 2, 128 08, Czechia|Fakultni nemocnice v Motole, Praha 5, 150 06, Czechia|Rigshospitalet - Børn og Unge, Copenhagen, 2100, Denmark|Odense Universitetshospital - HC Andersen Børne og Ungehospital, Odense C, 5000, Denmark|Aarhus Universitetshospital - Børn og Unge, Århus N, 8200, Denmark|Helsinki University Hospital | Children's Hospital - Clinical Trial Unit, Nephrology Department, Helsinki, 290, Finland|Tays Service Centre | Tampere University Hospital - Pediatric Early Phase Clinical Trials Unit, Tampere, 33521, Finland|Turun yliopistollinen keskussairaala, Turku, 20520, Finland|Hôpital Pellegrin - Bordeaux, BORDEAUX cedex, 33076, France|CHU de Lyon - Hopital Femme Mère Enfant, Bron, 69677, France|Hopital Arnaud de Villeneuve CHU Montpellier, Montpellier, 34059, France|Hopital Robert Debre, Paris, 75019, France|CHU Strasbourg - Hopital Hautepierre, Strasbourg, 67200, France|Hôpital des Enfants, TOULOUSE Cedex 9, 31059, France|Universitätsklinikum Heidelberg, Heidelberg, Baden-Württemberg, 69115, Germany|Universitätsklinikum Erlangen, Erlangen, Bayern, 91054, Germany|Medizinische Hochschule Hannover (MHH), Hannover, Niedersachsen, 30625, Germany|Kindernierenzentrum Bonn, Bonn, Nordrhein-Westfalen, 53127, Germany|Universitätsklinikum Essen, Essen, Nordrhein-Westfalen, 45147, Germany|Universitaetsklinikum Muenster, Münster, Nordrhein-Westfalen, 48149, Germany|Charité / Pädiatrie, Berlin, 13353, Germany|Universitätsklinikum Hamburg Eppendorf (UKE), Hamburg, 20246, Germany|Children's Hospital of Athens Agia Sofia - Pediatric Nephrology Department, Athens, 11527, Greece|Children's Hospital of Athens P&A Kyriakou - Pediatric Nephrology Department, Athens, TBC, Greece|University General Hospital of Heraklion - Department of Paediatrics, Heraklion, 711 10, Greece|Univ. General Hospital of Ioannina - Department of Paediatrics, Nephrology Unit, Ioannina, 45500, Greece|Hippokration General Hospital of Thessaloniki - 3rd Department of Paediatrics, Nephrology Unit', Thessaloniki, 54642, Greece|Semmelweis University, Budapest, 1083, Hungary|Debreceni Egyetem Klinikai Kozpont, Debrecen, 4032, Hungary|Pecsi Tudomanyegyetem Klinikai Kozpont, Pecs, 7623, Hungary|SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont, Szeged, 6720, Hungary|St. John's National Academy of Health Sciences, Bangalore, 560034, India|All India Institute of Medical Sciences (AIIMS) - New Delhi, Delhi, 110029, India|NRS Medical college, Kolkata, 700014, India|Clalit Health | Soroka Medical Center - Internal Medicine Department, Beer Sheva, 8410101, Israel|Wilf Children's Hospital Shaare Zedek Medical Center, Jerusalem, 9103102, Israel|Health Corporation of Galilee Medical Center, Nahariya, 2210001, Israel|Clalit Health Services Schneider Children's Medical Center, Petach Tikva, 4920235, Israel|Dana-Dwek Children's Hospital, Tel Aviv, 6423906, Israel|Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Pediatria, Bologna, Emilia-Romagna, 40138, Italy|Ospedale Pediatrico Bambino Gesù - Nefrologia, Roma, Lazio, 00165, Italy|IRCCS Istituto Giannina Gaslini - Nefrologia e Trapianto Rene, Genova, Liguria, 16147, Italy|Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Nefrologia e Dialisi Pediatrica, Trapianti di Rene, Milano, Lombardia, 20122, Italy|Azienda Ospedaliera Universitaria Meyer IRCCS - Nefrologia e Dialisi, Firenze, 50139, Italy|A.O.U. Città della Salute e della Scienza di Torino_Regina Margherita - Nefrologia Pediatrica, Torino, 10126, Italy|Kyungpook National University Hospital, Daegu, Daegu Gwang''yeogsi, 41944, Korea, Republic of|Seoul National University Bundang Hospital, Seongnam-si, Gyeonggido, 13620, Korea, Republic of|Pusan National University Yangsan Hospital, Yangsan-si, Gyeongsangnamdo, 50612, Korea, Republic of|Korea University Guro Hospital, Seoul, Seoul Teugbyeolsi, 152-703, Korea, Republic of|Seoul National University Hospital, Seoul, Seoul Teugbyeolsi, 3080, Korea, Republic of|Hospital of LT University of Health Sciences Kaunas Clinics, Kaunas, LT-50161, Lithuania|Klaipeda Children's Hospital, Klaipeda, LT-92140, Lithuania|Vilnius University Hospital Santaros Klinikos Children's Hospital Paediatrics Centre, Vilnius, LT-08406, Lithuania|Hospital Tunku Azizah, Wilayah Persekutuan, Kuala Lumpur, 50300, Malaysia|Hospital Tuanku Ja'afar, Seremban, Negeri Sembilan, 70300, Malaysia|Hospital Selayang, Shah Alam, Selangor, 68100, Malaysia|Sunway Medical Centre, Subang Jaya, Selangor, 47500, Malaysia|Hospital Universiti Sains Malaysia, Kelantan, 16150, Malaysia|Sitio Alfredo Chew Wong | Aguascalientes, Mexico, Aguascalientes, Agguascalientes, 20124, Mexico|Instituto Veracruzano en Investigación Clinica SC, Ciudad de Mexico, Distrito Federal, 11850, Mexico|Hospital Infantil de México "Dr. Federico Gómez", México D.F., Distrito Federal, 6720, Mexico|Instituto Nacional de Pediatría, México, D.F., Distrito Federal, 4530, Mexico|Hospital Regional de Alta Especialidad Ixtapaluca, Ixtapaluca, Estado De Mexico, 56530., Mexico|Universitair Medisch Centrum Groningen, Groningen, 9713 GZ, Netherlands|Universitair Medisch Centrum St. Radboud, Nijmegen, 6525 GA, Netherlands|University Medical Center Utrecht, Utrecht, 3584 CX, Netherlands|Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa, Bialystok, 15-274, Poland|Uniwersyteckie Centrum Kliniczne, Gdansk, 80-952, Poland|Uniwersytecki Szpital Dzieciecy w Krakowie, Krakow, 30-663, Poland|Instytut Centrum Zdrowia Matki Polki, Lodz, 93-338, Poland|Dzieciecy Szpital Kliniczny im. Jozefa Brudzinskiego, Warszawa, 02-091, Poland|Instytut "Pomnik - Centrum Zdrowia Dziecka", Warszawa, 04-730, Poland|Uniwersytecki Szpital Kliniczny UM we Wroclawiu, Wroclaw, 50-556, Poland|Hospital Santa Maria | Centro de Investigacao Clinica, Missing, Lisboa, 1649-035, Portugal|Centro Clinico Academico Braga | Braga, Portugal, Braga, 4710-243, Portugal|Hospital Pediátrico de Coimbra I ULS Coimbra, Coimbra, 3000, Portugal|Centro Hospitalar Universitario do Porto | Servico de Investigacao Clinica, Porto, 4050-651, Portugal|Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit, Soweto, Gauteng, 1862, South Africa|Ciutat Sanitaria i Universitaria de la Vall d'Hebron, Barcelona, 08035, Spain|Hospital de Sant Joan de Déu, Barcelona, 08950, Spain|H Univ. 12 de Octubre | Unidad Pediátrica Inv y EECC (UPIC), Madrid, 28041, Spain|Hospital la Paz, Madrid, 28046, Spain|University Hospital of Malaga | Unidad de Gestion Clinica de Pediatria, Málaga, 29010, Spain|Virgen del Rocio University Hospital | Pediatric Nephrology Unit, Sevilla, 41013, Spain|Skånes Universitetssjukhus Lund - Barnnefroenheten, Lund, 22185, Sweden|Karolinska University Hospital, Stockholm, 141 86, Sweden|Uppsala University Hospital, Uppsala, 751 85, Sweden|Universitäts-Kinderspital UKBB, Basel, Basel-Stadt, 4056, Switzerland|Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Vaud, 1011, Switzerland|Hopital des Enfants HUG, Geneva, 1211, Switzerland|Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch, Guishan, 83301, Taiwan|National Taiwan University Hospital, Taipei, 100229, Taiwan|Taipei Veterans General Hospital, Taipei, 11217, Taiwan|Cukurova Univ. Tip. Fak. Balcali Hastanesi, Adana, 01790, Turkey|Hacettepe Universitesi Tip Fakultesi, Ankara, 6100, Turkey|Baskent Universitesi Tip Fakultesi Hastanesi, Ankara, 6490, Turkey|Gazi Universitesi Tip Fakultesi, Ankara, 6560, Turkey|Health Ministry Of Türkiye Republic Ankara Bilkent City Hospital, Ankara, 6800, Turkey|Istanbul Faculty of Medicine, Department of Internal Medicine, Department of Pediatrics, Istanbul, 34093, Turkey|Istanbul Universitesi Cerrahpasa - Cocuk Nefrolojisi, Istanbul, 34098, Turkey|Marmara University Medical Faculty | Pediatric Nephrology, Istanbul, 34899, Turkey|Birmingham Children's Hospital, Birmingham, West Midlands, B4 6NH, United Kingdom|Royal Hospital for Children, Glasgow, G51 4TF, United Kingdom|Great Ormond Street Hospital for Children, London, WC1N 3JH, United Kingdom|Royal Manchester Children's Hospital, Manchester, M13 9WL, United Kingdom|Queens Medical Centre, Nottingham, NG7 2UH, United Kingdom
URL: https://clinicaltrials.gov/show/NCT05196035

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress