Clinical trial • Phase III • Nephrology
FINERENONE for Chronic kidney disease | Proteinuria
Phase III trial of FINERENONE for Chronic kidney disease | Proteinuria. open-label, none/not specified-controlled. 40 participants.
Overview
- Trial Therapeutic Area
- Nephrology
- Trial Disease
- Chronic kidney disease | Proteinuria
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 21-02-2024
- First CTIS Authorization Date
- 27-03-2024
Trial design
open-label, none/not specified-controlled Phase III trial in Italy, Denmark, Austria and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 40
- Trial Duration For Participant
- 540
Eligibility
Recruits 40 paediatric patients.
- Pregnancy Exclusion
- Pregnant or breastfeeding or intention to become pregnant during the study
- Vulnerable Population
- Participants are children and young adults aged 1–18 years. Consent/assent handling requires informed consent from parent(s)/legal guardian and assent from children as appropriate. Age‑specific information sheets, consent and assent forms (Core, Pre-teen, Teen, Parents, Expecting Parents, Study Update versions) and country/language-specific documents are provided (multiple country ICFs and assent templates are listed in the application documents). Decentralised trial (DCT) consent versions are also available where applicable.
Inclusion criteria
- {"criterion_text":"- Participants must be ≥1 year to 18 years of age, at the time of signing the informed consent/assent."}
- {"criterion_text":"- 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."}
- {"criterion_text":"- 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"}
- {"criterion_text":"- 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 (or local label / guidelines as applicable), unchanged for at least 30 days prior to Visit 1."}
- {"criterion_text":"- 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"}
- {"criterion_text":"- 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
- {"criterion_text":"- Planned urological surgery expected to influence renal function"}
- {"criterion_text":"- Concomitant therapy with strong cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, moderate or strong CYP3A4 inducers"}
- {"criterion_text":"- Previous assignment to treatment during this study"}
- {"criterion_text":"- Simultaneous participation in another interventional clinical study (e.g., Phase 1 to 4 clinical studies)."}
- {"criterion_text":"- Any suspected (S)AE related to the study intervention which led to permanent discontinuation of study intervention during the FIONA study"}
- {"criterion_text":"- Pregnant or breastfeeding or intention to become pregnant during the study"}
- {"criterion_text":"- Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame"}
- {"criterion_text":"- Systemic hypertension Stage 2 defined according to institutional guidelines on BP management at Visit 1."}
- {"criterion_text":"- 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."}
- {"criterion_text":"- Known hypersensitivity to the study treatment (active substance or excipients)"}
- {"criterion_text":"- Severe hepatic insufficiency defined by e.g. Child-Pugh C or analogous scores."}
- {"criterion_text":"- Participants with immune-mediated CKD using rituximab, cyclophosphamide, abatacept, or prolonged high-dose glucocorticoids (defined as ≥ 0.5 mg/kg/day of prednisolone or equivalent) for more than 7 days"}
- {"criterion_text":"- 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)"}
- {"criterion_text":"- Concomitant therapy with both ACEI and ARBs together"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Number of participants with treatment emergent adverse events (TEAEs)","definition_or_measurement_approach":"Count of participants experiencing treatment-emergent adverse events (TEAEs) during the study."}
- {"endpoint_text":"- Change in serum potassium levels from baseline to Day 540±7","definition_or_measurement_approach":"Change in measured serum potassium from baseline to Day 540 ± 7 days."}
- {"endpoint_text":"- Change in systolic blood pressure (SBP) from baseline to Day 540±7","definition_or_measurement_approach":"Change in measured systolic blood pressure (SBP) from baseline to Day 540 ± 7 days."}
Secondary endpoints
- {"endpoint_text":"- Change in urinary protein-to-creatinine ratio (UPCR) and urinary albumin-to-creatinine ratio (UACR) from baseline to Day 540±7","definition_or_measurement_approach":"Change in UPCR and UACR measured from baseline to Day 540 ± 7 days."}
- {"endpoint_text":"- Change in estimated glomerular filtration rate (eGFR) from baseline to Day 540±7","definition_or_measurement_approach":"Change in estimated glomerular filtration rate (eGFR) from baseline to Day 540 ± 7 days."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 40
- Recruitment Window Months
- 75
- Consent Approach
- Informed consent is required from the parent(s)/legal guardian and assent from minors as appropriate; participants must sign the informed consent/assent. Age-specific information sheets and consent/assent forms are provided (Core, Pre-teen, Teen, Parents, Expecting Parents, Study Update versions) and country-specific language versions are available across participating Member States. Decentralised clinical trial (DCT) consent/materials are available for some countries (DCT-labelled ICFs present).
Geography
- Total Number Of Sites
- 67
- Total Number Of Participants
- 69
Italy
- Earliest CTIS Part Ii Submission Date
- 04-03-2024
- Latest Decision Or Authorization Date
- 28-04-2026
- Processing Time Days
- 785
- Number Of Sites
- 6
- Number Of Participants
- 5
Sites
- Site Name
- Ospedale Pediatrico Bambino Gesu'
- Department Name
- Division of Nephrology and Dialysis, Department of Pediatric Subspecialties
- Principal Investigator Name
- Marina Vivarelli
- Principal Investigator Email
- marina.vivarelli@opbg.net
- Contact Person Name
- Marina Vivarelli
- Contact Person Email
- marina.vivarelli@opbg.net
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- U.O. Pediatria, Programma di Nefrologia Pediatrica – Pad. 13
- Principal Investigator Name
- Andrea Pasini
- Principal Investigator Email
- andrea.pasini@aosp.bo.it
- Contact Person Name
- Andrea Pasini
- Contact Person Email
- andrea.pasini@aosp.bo.it
- Site Name
- Giannina Gaslini Institute For Scientific Hospitalization And Care
- Department Name
- Department of Nephrology, dialysis and transplantation
- Principal Investigator Name
- Eugenio Verrina
- Principal Investigator Email
- enricoverrina@gaslini.org
- Contact Person Name
- Eugenio Verrina
- Contact Person Email
- enricoverrina@gaslini.org
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Pediatric Nephrology, Dialysis and Transplant Unit
- Principal Investigator Name
- William Morello
- Principal Investigator Email
- william.morello@policlinico.mi.it
- Contact Person Name
- William Morello
- Contact Person Email
- william.morello@policlinico.mi.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- Nephrology, Dialysis and TransplantaƟon Unit
- Principal Investigator Name
- Licia Peruzzi
- Principal Investigator Email
- lperuzzi@cittadellasalute.to.it
- Contact Person Name
- Licia Peruzzi
- Contact Person Email
- lperuzzi@cittadellasalute.to.it
- Site Name
- Azienda Ospedaliera Universitaria Meyer IRCCS
- Department Name
- Pediatric Nephrology and Dialysis Unit
- Principal Investigator Name
- Francesca Becherucci
- Principal Investigator Email
- francesca.becherucci@meyer.it
- Contact Person Name
- Francesca Becherucci
- Contact Person Email
- francesca.becherucci@meyer.it
Denmark
- Earliest CTIS Part Ii Submission Date
- 04-03-2024
- Latest Decision Or Authorization Date
- 26-04-2026
- Processing Time Days
- 783
- Number Of Sites
- 3
- Number Of Participants
- 2
Sites
- Site Name
- Rigshospitalet
- Department Name
- BørneUngeAfdelingen Afsnit 4072 (opgang 4, 7. sal)
- Principal Investigator Name
- Ida Maria Schmidt
- Principal Investigator Email
- ida.maria.schmidt@regionh.dk
- Contact Person Name
- Ida Maria Schmidt
- Contact Person Email
- ida.maria.schmidt@regionh.dk
- Site Name
- Aarhus Universitetshospital
- Department Name
- Børn og Unge, Krydspunkt H301, Plan 3
- Principal Investigator Name
- Konstantinos Kamperis
- Principal Investigator Email
- konskamp@rm.dk
- Contact Person Name
- Konstantinos Kamperis
- Contact Person Email
- konskamp@rm.dk
- Site Name
- Odense University Hospital
- Department Name
- H.C. Andersen Børnehospital
- Principal Investigator Name
- Per Wittenhagen
- Principal Investigator Email
- per.wittenhagen@rsyd.dk
- Contact Person Name
- Per Wittenhagen
- Contact Person Email
- per.wittenhagen@rsyd.dk
Austria
- Earliest CTIS Part Ii Submission Date
- 04-03-2024
- Latest Decision Or Authorization Date
- 28-04-2026
- Processing Time Days
- 785
- Number Of Sites
- 4
- Number Of Participants
- 2
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Pediatrics and Adolescent Medicine
- Principal Investigator Name
- Krisztina Heindl-Rusai
- Principal Investigator Email
- krisztina.rusai@meduniwien.ac.at
- Contact Person Name
- Krisztina Heindl-Rusai
- Contact Person Email
- krisztina.rusai@meduniwien.ac.at
- Site Name
- Kepler Universitaetsklinikum GmbH
- Department Name
- Pediatrics and Adolescent Medicine
- Principal Investigator Name
- Roland Lanzersdorfer
- Principal Investigator Email
- roland.lanzersdorfer@kepleruniklinikum.at
- Contact Person Name
- Roland Lanzersdorfer
- Contact Person Email
- roland.lanzersdorfer@kepleruniklinikum.at
- Site Name
- Medical University Of Graz
- Department Name
- Pediatrics and Adolescent Medicine
- Principal Investigator Name
- Christoph Mache
- Principal Investigator Email
- christoph.mache@medunigraz.at
- Contact Person Name
- Christoph Mache
- Contact Person Email
- christoph.mache@medunigraz.at
- Site Name
- Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
- Department Name
- Pediatrics and Adolescent Medicine
- Principal Investigator Name
- Monika Edelbauer-Wechselberger
- Principal Investigator Email
- m.edelbauer-wechselberger@salk.at
- Contact Person Name
- Monika Edelbauer-Wechselberger
- Contact Person Email
- m.edelbauer-wechselberger@salk.at
Poland
- Earliest CTIS Part Ii Submission Date
- 28-03-2024
- Latest Decision Or Authorization Date
- 27-04-2026
- Processing Time Days
- 784
- Number Of Sites
- 4
- Number Of Participants
- 8
Sites
- Site Name
- Instytut Centrum Zdrowia Matki Polki
- Department Name
- Klinika Pediatrii, Immunologii i Nefrologii
- Principal Investigator Name
- Marcin Tkaczyk
- Principal Investigator Email
- sek31@iczmp.edu.pl
- Contact Person Name
- Marcin Tkaczyk
- Contact Person Email
- sek31@iczmp.edu.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Chorob Nerek i Nadcisnienia Dzieci i Młodziezy
- Principal Investigator Name
- Aleksandra Zurowska
- Principal Investigator Email
- nefrologiadziecieca@uck.gda.pl
- Contact Person Name
- Aleksandra Zurowska
- Contact Person Email
- nefrologiadziecieca@uck.gda.pl
- Site Name
- Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku samodzielny publiczny zakład opieki zdrowotnej
- Department Name
- Klinika Pediatrii i Nefrologii
- Principal Investigator Name
- Anna Wasilewska
- Principal Investigator Email
- nefrologia@udsk.pl
- Contact Person Name
- Anna Wasilewska
- Contact Person Email
- nefrologia@udsk.pl
- Site Name
- Instytut Pomnik Centrum Zdrowia Dziecka
- Department Name
- Klinika Nefrologii, Transplantacji Nerek i Nadcisnienia Tetniczego
- Principal Investigator Name
- Malgorzata Podymniak-Grzeszykowska
- Principal Investigator Email
- oddzial.nefrologia@ipczd.pl
- Contact Person Name
- Malgorzata Podymniak-Grzeszykowska
- Contact Person Email
- oddzial.nefrologia@ipczd.pl
France
- Earliest CTIS Part Ii Submission Date
- 04-03-2024
- Latest Decision Or Authorization Date
- 28-04-2026
- Processing Time Days
- 785
- Number Of Sites
- 6
- Number Of Participants
- 8
Sites
- Site Name
- Hospices Civils De Lyon
- Department Name
- Service de néphrologie - rhumatologie - dermatologie pédiatrique
- Principal Investigator Name
- Justine Bacchetta
- Principal Investigator Email
- ghe.ciclyon@chu-lyon.fr
- Contact Person Name
- Justine Bacchetta
- Contact Person Email
- ghe.ciclyon@chu-lyon.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service de Néphrologie - Transplantation - Hémodialyse pédiatrique
- Principal Investigator Name
- Julien Hogan
- Principal Investigator Email
- sabrina.ouamdi@aphp.fr
- Contact Person Name
- Julien Hogan
- Contact Person Email
- sabrina.ouamdi@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Service de Néphrologie pédiatrique
- Principal Investigator Name
- Marc Fila
- Principal Investigator Email
- cic@chu-montpellier.fr
- Contact Person Name
- Marc Fila
- Contact Person Email
- cic@chu-montpellier.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Unité de Néphrologie Service de Pédiatrie
- Principal Investigator Name
- Jérôme Harambat
- Principal Investigator Email
- cic-p.coordination@chu-bordeaux.fr
- Contact Person Name
- Jérôme Harambat
- Contact Person Email
- cic-p.coordination@chu-bordeaux.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Service de Néphrologie pédiatrique
- Principal Investigator Name
- Ariane Zaloszyc
- Principal Investigator Email
- cic@chru-strasbourg.fr
- Contact Person Name
- Ariane Zaloszyc
- Contact Person Email
- cic@chru-strasbourg.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Pédiatrie - Néphrologie, médecine interne et hypertension
- Principal Investigator Name
- Stéphane Decramer
- Principal Investigator Email
- Drci.toulouse@chu-toulouse.fr
- Contact Person Name
- Stéphane Decramer
- Contact Person Email
- Drci.toulouse@chu-toulouse.fr
Finland
- Earliest CTIS Part Ii Submission Date
- 04-03-2024
- Latest Decision Or Authorization Date
- 23-04-2026
- Processing Time Days
- 780
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- Site Name
- Tampere University Hospital
- Department Name
- Lasten Lääketutkimuskeskus PeeTU
- Principal Investigator Name
- Sauli Palmu
- Principal Investigator Email
- sauli.palmu@pirha.fi
- Contact Person Name
- Sauli Palmu
- Contact Person Email
- sauli.palmu@pirha.fi
- Site Name
- HUS-Yhtymae
- Department Name
- Lasten Uusi Sairaala
- Principal Investigator Name
- Tuula Hölttä
- Principal Investigator Email
- tuula.holtta@hus.fi
- Contact Person Name
- Tuula Hölttä
- Contact Person Email
- tuula.holtta@hus.fi
- Site Name
- Turku University Hospital
- Department Name
- Majakkasairaala, Lasten ja Nuorten klinikka
- Principal Investigator Name
- Janne Kataja
- Principal Investigator Email
- janne.kataja@varha.fi
- Contact Person Name
- Janne Kataja
- Contact Person Email
- janne.kataja@varha.fi
Spain
- Earliest CTIS Part Ii Submission Date
- 04-03-2024
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 781
- Number Of Sites
- 6
- Number Of Participants
- 5
Sites
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Pediatric Nephrology
- Principal Investigator Name
- Verónica Martínez Rivera
- Principal Investigator Email
- veronicad.martinez.sspa@juntadeandalucia.es
- Contact Person Name
- Verónica Martínez Rivera
- Contact Person Email
- veronicad.martinez.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario La Paz
- Department Name
- Pediatric Nephrology
- Principal Investigator Name
- Marta Melgosa Hijosa
- Principal Investigator Email
- marta.melgosa@salud.madrid.org
- Contact Person Name
- Marta Melgosa Hijosa
- Contact Person Email
- marta.melgosa@salud.madrid.org
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Pediatric Nephrology
- Principal Investigator Name
- Francisco de la Cerda Ojeda
- Principal Investigator Email
- Francisco.cerda.sspa@juntadeandalucia.es
- Contact Person Name
- Francisco de la Cerda Ojeda
- Contact Person Email
- Francisco.cerda.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Pediatric Nephrology
- Principal Investigator Name
- Gema Ariceta Iraola
- Principal Investigator Email
- gema.ariceta@vallhebron.cat
- Contact Person Name
- Gema Ariceta Iraola
- Contact Person Email
- gema.ariceta@vallhebron.cat
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Pediatric Nephrology
- Principal Investigator Name
- Maria del Mar Espino Hernández
- Principal Investigator Email
- mar.espino@salud.madrid.org
- Contact Person Name
- Maria del Mar Espino Hernández
- Contact Person Email
- mar.espino@salud.madrid.org
- Site Name
- Sant Joan De Deu Barcelona Hospital
- Department Name
- Pediatric Nephrology
- Principal Investigator Name
- Álvaro Domingo Madrid Aris
- Principal Investigator Email
- alvaro.madrid@sjd.es
- Contact Person Name
- Álvaro Domingo Madrid Aris
- Contact Person Email
- alvaro.madrid@sjd.es
Czechia
- Earliest CTIS Part Ii Submission Date
- 04-03-2024
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 781
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Fakultni Nemocnice V Motole
- Department Name
- Pediatrická klinika
- Principal Investigator Name
- Jakub Zieg
- Principal Investigator Email
- Jakub.Zieg@fnmotol.cz
- Contact Person Name
- Jakub Zieg
- Contact Person Email
- Jakub.Zieg@fnmotol.cz
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- Klinika pediatrie a dědičných poruch metabolismu
- Principal Investigator Name
- Šárka Doležalová
- Principal Investigator Email
- Sarka.Dolezalova@vfn.cz
- Contact Person Name
- Šárka Doležalová
- Contact Person Email
- Sarka.Dolezalova@vfn.cz
Portugal
- Earliest CTIS Part Ii Submission Date
- 11-04-2024
- Latest Decision Or Authorization Date
- 23-04-2026
- Processing Time Days
- 780
- Number Of Sites
- 2
- Number Of Participants
- 1
Sites
- Site Name
- Unidade Local De Saude De Coimbra E.P.E.
- Department Name
- Pediatrics
- Principal Investigator Name
- Marta Machado
- Principal Investigator Email
- martamachado@ulscoimbra.min-saude.pt
- Contact Person Name
- Marta Machado
- Contact Person Email
- martamachado@ulscoimbra.min-saude.pt
- Site Name
- Centro Hospitalar Universitario De Santo Antonio E.P.E.
- Department Name
- Unidade de Pediatria
- Principal Investigator Name
- Alberto Caldas Afonso
- Principal Investigator Email
- caldasafonso.cmin@chporto.min-saude.pt
- Contact Person Name
- Alberto Caldas Afonso
- Contact Person Email
- caldasafonso.cmin@chporto.min-saude.pt
Sweden
- Earliest CTIS Part Ii Submission Date
- 27-03-2024
- Latest Decision Or Authorization Date
- 23-04-2026
- Processing Time Days
- 780
- Number Of Sites
- 3
- Number Of Participants
- 2
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- K88 Dagvård, Barnnefrologi, Karolinska universitetssjukhuset Huddinge
- Principal Investigator Name
- Peter Bárány
- Principal Investigator Email
- forumstockholmgotland.karolinska@regionstockholm.se
- Contact Person Name
- Peter Bárány
- Contact Person Email
- forumstockholmgotland.karolinska@regionstockholm.se
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Barnnefroenheten, Barnkliniken, Lasarettsgatan 48
- Principal Investigator Name
- Lisa Sartz
- Principal Investigator Email
- forumsoder@skane.se
- Contact Person Name
- Lisa Sartz
- Contact Person Email
- forumsoder@skane.se
- Site Name
- Uppsala University Hospital
- Department Name
- Njur- & urinvägsmottagningen för barn & ungdom, Akademiska barnsjukhuset, Ingång 95/96, NBV
- Principal Investigator Name
- Site Closed
- Principal Investigator Email
- site_closed@site-closed.se
- Contact Person Name
- Site Closed
- Contact Person Email
- site_closed@site-closed.se
Netherlands
- Earliest CTIS Part Ii Submission Date
- 28-03-2024
- Latest Decision Or Authorization Date
- 23-04-2026
- Processing Time Days
- 780
- Number Of Sites
- 2
- Number Of Participants
- 1
Sites
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Pediatric Nephrology
- Principal Investigator Name
- Martine T. P. Besouw
- Principal Investigator Email
- m.t.p.besouw@umcg.nl
- Contact Person Name
- Martine T. P. Besouw
- Contact Person Email
- m.t.p.besouw@umcg.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Pediatric Nephrology
- Principal Investigator Name
- Mandy Gabriëlle Keijzer-Veen
- Principal Investigator Email
- m.g.veen-14@umcutrecht.nl
- Contact Person Name
- Mandy Gabriëlle Keijzer-Veen
- Contact Person Email
- m.g.veen-14@umcutrecht.nl
Germany
- Earliest CTIS Part Ii Submission Date
- 27-03-2024
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 781
- Number Of Sites
- 7
- Number Of Participants
- 7
Sites
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Klinik für Kinder- und Jugendmedizin
- Principal Investigator Name
- Jun Oh
- Principal Investigator Email
- j.oh@uke.de
- Contact Person Name
- Jun Oh
- Contact Person Email
- j.oh@uke.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Paediatrisches Klinisch-Pharmakologisches Studienzentrum (paedKliPS)
- Principal Investigator Name
- Elke Wuehl
- Principal Investigator Email
- Elke.Wuehl@med.uni-heidelberg.de
- Contact Person Name
- Elke Wuehl
- Contact Person Email
- Elke.Wuehl@med.uni-heidelberg.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Klinik für Pädiatrie mit Schwerpunkt Gastroenterologie, Nephrologie und Stoffwechselmedizin
- Principal Investigator Name
- Julia Thumfart
- Principal Investigator Email
- julia.thumfart@charite.de
- Contact Person Name
- Julia Thumfart
- Contact Person Email
- julia.thumfart@charite.de
- Site Name
- Kindernierenzentrum Bonn
- Principal Investigator Name
- Gesa Schalk
- Principal Investigator Email
- gesa.schalk@knz-bonn.de
- Contact Person Name
- Gesa Schalk
- Contact Person Email
- gesa.schalk@knz-bonn.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik für Paediatrische Nieren-, Leber- und Stoffwechselerkrankungen
- Principal Investigator Name
- Nele Kanzelmeyer
- Principal Investigator Email
- Kanzelmeyer.Nele@mh-hannover.de
- Contact Person Name
- Nele Kanzelmeyer
- Contact Person Email
- Kanzelmeyer.Nele@mh-hannover.de
- Site Name
- Universitaetsklinikum Muenster AöR
- Department Name
- Klinik fuer Kinder- und Jugendmedizin - Allgemeine Paediatrie
- Principal Investigator Name
- Martin Konrad
- Principal Investigator Email
- Martin.Konrad@ukmuenster.de
- Contact Person Name
- Martin Konrad
- Contact Person Email
- Martin.Konrad@ukmuenster.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Klinik für Kinderheilkunde II
- Principal Investigator Name
- Lars Pape
- Principal Investigator Email
- Lars.Pape@uk-essen.de
- Contact Person Name
- Lars Pape
- Contact Person Email
- Lars.Pape@uk-essen.de
Belgium
- Earliest CTIS Part Ii Submission Date
- 04-03-2024
- Latest Decision Or Authorization Date
- 27-04-2026
- Processing Time Days
- 785
- Number Of Sites
- 5
- Number Of Participants
- 5
Sites
- Site Name
- Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
- Department Name
- Néphrologie - Dialyse
- Principal Investigator Name
- Elise Hennaut
- Principal Investigator Email
- elise.hennaut@hubruxelles.be
- Contact Person Name
- Elise Hennaut
- Contact Person Email
- elise.hennaut@hubruxelles.be
- Site Name
- UZ Leuven
- Department Name
- Kindernefrologie en orgaantransplantatie
- Principal Investigator Name
- Detlef Böckenhauer
- Principal Investigator Email
- detlef.bockenhauer@uzleuven.be
- Contact Person Name
- Detlef Böckenhauer
- Contact Person Email
- detlef.bockenhauer@uzleuven.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Néphrologie Pédiatrique
- Principal Investigator Name
- Nathalie Godefroid
- Principal Investigator Email
- nathalie.godefroid@saintluc.uclouvain.be
- Contact Person Name
- Nathalie Godefroid
- Contact Person Email
- nathalie.godefroid@saintluc.uclouvain.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Kindernefrologie
- Principal Investigator Name
- Evelien Snauwaert
- Principal Investigator Email
- secretariaat.kindernefrologie@uzgent.be
- Contact Person Name
- Evelien Snauwaert
- Contact Person Email
- secretariaat.kindernefrologie@uzgent.be
- Site Name
- CHC MontLegia
- Department Name
- Néphrologie pédiatrique
- Principal Investigator Name
- Laure Collard
- Principal Investigator Email
- LAURE.COLLARD@chc.be
- Contact Person Name
- Laure Collard
- Contact Person Email
- LAURE.COLLARD@chc.be
Lithuania
- Earliest CTIS Part Ii Submission Date
- 08-05-2024
- Latest Decision Or Authorization Date
- 23-04-2026
- Processing Time Days
- 780
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
- Department Name
- Pediatrijos centras
- Principal Investigator Name
- Augustina Jankauskienė
- Principal Investigator Email
- augustina.jankauskiene@santa.lt
- Contact Person Name
- Augustina Jankauskienė
- Contact Person Email
- augustina.jankauskiene@santa.lt
- Site Name
- Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
- Department Name
- I vaikų ligų skyrius
- Principal Investigator Name
- Jūratė Masalskienė
- Principal Investigator Email
- jurate.masalskiene@kaunoklinikos.lt
- Contact Person Name
- Jūratė Masalskienė
- Contact Person Email
- jurate.masalskiene@kaunoklinikos.lt
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 07-11-2025
- Latest Decision Or Authorization Date
- 28-04-2026
- Processing Time Days
- 172
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- Specialized Hospital For Active Treatment Of Childrens Diseases Professor Ivan Mitev
- Department Name
- Clinic of Pediatric Nephrology and Dialysis – dialysis treatment
- Principal Investigator Name
- Galya Zlatanova
- Principal Investigator Email
- zlatanova_g@pediatrichospital.bg
- Contact Person Name
- Galya Zlatanova
- Contact Person Email
- zlatanova_g@pediatrichospital.bg
- Site Name
- Umbal - Prof. D-R Stoyan Kirkovich AD
- Department Name
- Clinic of Pediatrics
- Principal Investigator Name
- Emiliya Kostadinova
- Principal Investigator Email
- kostadinovaemilia@abv.bg
- Contact Person Name
- Emiliya Kostadinova
- Contact Person Email
- kostadinovaemilia@abv.bg
- Site Name
- University Multiprofile Hospital For Active Treatment Saint Georgi EAD
- Department Name
- Clinic of Pediatrics
- Principal Investigator Name
- Petya Markova
- Principal Investigator Email
- klinikadetska@gmail.com
- Contact Person Name
- Petya Markova
- Contact Person Email
- klinikadetska@gmail.com
Hungary
- Earliest CTIS Part Ii Submission Date
- 04-03-2024
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 781
- Number Of Sites
- 4
- Number Of Participants
- 2
Sites
- Site Name
- Semmelweis University
- Department Name
- I. Sz. Gyermekgyogyaszati Klinika
- Principal Investigator Name
- Balint Mikes
- Principal Investigator Email
- mikesbalint@gmail.com
- Contact Person Name
- Balint Mikes
- Contact Person Email
- mikesbalint@gmail.com
- Site Name
- University Of Debrecen
- Department Name
- Gyermekgyogyaszati Klinika
- Principal Investigator Name
- Tamas Szabo
- Principal Investigator Email
- gyermeknephrologia@gmail.com
- Contact Person Name
- Tamas Szabo
- Contact Person Email
- gyermeknephrologia@gmail.com
- Site Name
- University Of Szeged
- Department Name
- Gyermekgyogyaszati Klinika es Gyermekegeszsegugyi Kozpont
- Principal Investigator Name
- Csaba Bereczki
- Principal Investigator Email
- study.pedia@med.u-szeged.hu
- Contact Person Name
- Csaba Bereczki
- Contact Person Email
- study.pedia@med.u-szeged.hu
- Site Name
- University Of Pecs
- Department Name
- Gyermekgyogyaszati Klinika
- Principal Investigator Name
- Tamas Decsi
- Principal Investigator Email
- gyereknefrologia.pecs@pte.hu
- Contact Person Name
- Tamas Decsi
- Contact Person Email
- gyereknefrologia.pecs@pte.hu
Greece
- Earliest CTIS Part Ii Submission Date
- 13-05-2024
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 781
- Number Of Sites
- 5
- Number Of Participants
- 5
Sites
- Site Name
- Nosokomeio Paidon I Agia Sofia
- Department Name
- 1st Clinic of Pediatrics, Nephrology Department
- Principal Investigator Name
- Nikolaos Stergiou
- Principal Investigator Email
- pednephr@paidon-agiasofia.gr
- Contact Person Name
- Nikolaos Stergiou
- Contact Person Email
- pednephr@paidon-agiasofia.gr
- Site Name
- Ippokratio General Hospital Of Thessaloniki
- Department Name
- Pediatric Nephrology Unit, 3rd Department of Paediatrics
- Principal Investigator Name
- Ioannis Ntotis
- Principal Investigator Email
- doctors-gpaid@ippokratio.gr
- Contact Person Name
- Ioannis Ntotis
- Contact Person Email
- doctors-gpaid@ippokratio.gr
- Site Name
- Athens General Children's Hospital Panagioti And Aglaia Kyriakou
- Department Name
- Pediatric Nephrology Department
- Principal Investigator Name
- Varvara Askiti
- Principal Investigator Email
- mtnagkyriakou@gmail.com
- Contact Person Name
- Varvara Askiti
- Contact Person Email
- mtnagkyriakou@gmail.com
- Site Name
- University General Hospital Of Heraklion
- Department Name
- Department of Pediatrics
- Principal Investigator Name
- Maria Bitsori
- Principal Investigator Email
- paed@pagni.gr
- Contact Person Name
- Maria Bitsori
- Contact Person Email
- paed@pagni.gr
- Site Name
- University General Hospital Of Ioannina
- Department Name
- Child Health Sector
- Principal Investigator Name
- Aikaterini Siomou
- Principal Investigator Email
- ped.pgni@gmail.com
- Contact Person Name
- Aikaterini Siomou
- Contact Person Email
- ped.pgni@gmail.com
Sponsor
Primary sponsor
- Full Name
- Bayer AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- Eresearchtechnology Inc.
- Responsibilities
- ECG analysis/review, Echocardiography image analysis/review
- Name
- Labcorp Central Laboratory Services LP
- Responsibilities
- Central laboratory services
- Name
- Swiss BioQuant AG
- Responsibilities
- Pharmacokinetics analysis
- Name
- Fisher Clinical Services GmbH
- Name
- Suvoda LLC
- Name
- Illingworth Research Group Limited
- Responsibilities
- Decentralized Clinical Trial: Home Nursing
- Name
- DATAN Analytics GmbH
Third parties
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG analysis/review, Echocardiography image analysis/review","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Swiss BioQuant AG","duties_or_roles":"Pharmacokinetics analysis","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Switzerland","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Illingworth Research Group Limited","duties_or_roles":"Decentralized Clinical Trial: Home Nursing","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"Universitaetsklinikum Heidelberg AöR","duties_or_roles":"Expert consultation. ESCAPE sites will participate in the study","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Italy","full_name":"Fondazione Penta ETS","duties_or_roles":"Expert consultation: Fondazione Penta Onlus - conect4children (c4c) expert have participated in expert panel discussion","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Germany","full_name":"DATAN Analytics GmbH","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Finerenone
- Active Substance
- FINERENONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- Authorised
- Dose Levels
- max daily dose 10 mg (product record: maxDailyDoseAmount: 10 mg)
- Maximum Dose
- 10 mg
- Investigational Product Name
- BAY 94-8862
- Active Substance
- FINERENONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- Authorised
- Dose Levels
- max daily dose 20 mg (product record: maxDailyDoseAmount: 20 mg)
- Maximum Dose
- 20 mg
- Investigational Product Name
- BAY 948862 (granules for oral suspension)
- Active Substance
- FINERENONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral (granules for oral suspension)
- Authorisation Status
- Authorised
- Dose Levels
- max daily dose 20 mg (product record: maxDailyDoseAmount: 20 mg)
- Maximum Dose
- 20 mg
- Investigational Product Name
- Finerenone Bayer (paediatric granules for oral suspension)
- Active Substance
- FINERENONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral (granules)
- Authorisation Status
- Authorised
- Dose Levels
- max daily dose 20 mg (paediatric formulation record: maxDailyDoseAmount: 20 mg)
- Maximum Dose
- 20 mg
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.