Clinical trial • Phase III • Nephrology
FINERENONE for Chronic kidney disease | Proteinuria
Phase III trial of FINERENONE for Chronic kidney disease | Proteinuria.
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
- 07-02-2024
- First CTIS Authorization Date
- 18-03-2024
Trial design
Randomised, placebo matching finerenone (placebo to finerenone 10 film-coated tablets; placebo to finerenone 20 film-coated tablets; placebo to bay 948862). no active comparator; placebo control. Phase III trial in Sweden, Spain, Denmark and others.
- Randomised
- Yes
- Comparator
- Placebo matching finerenone (Placebo to Finerenone 10 film-coated tablets; Placebo to Finerenone 20 film-coated tablets; Placebo to BAY 948862). No active comparator; placebo control.
- Target Sample Size
- 261
- Trial Duration For Participant
- 180
Eligibility
Recruits 261 paediatric patients.
- Vulnerable Population
- The study population is pediatric (children aged 6 months to <18 years) and is flagged as a vulnerable population. Informed consent must be obtained from parent(s)/legal guardian(s) and age-appropriate assent is obtained from children as applicable. Multiple age-specific information and consent/assent documents are provided (parental ICFs and assent forms for teens 15-17, children 12-14, small children/7-11, pre‑teens, toddlers/infants), and country/language-specific versions are available.
Inclusion criteria
- {"criterion_text":"- Participants must be 6 months to <18 years old at the time when the informed consent/assent is signed\n- Participants must have a clinical diagnosis of chronic kidney disease (CKD) at screening which is defined as a. CKD stages 1-3 (eGFR ≥30 mL/min/1.73m^2) for children ≥1 year to <18 years of age or b. a serum creatinine ≤ 0.40 mg/dL for infants 6 months to < 1 year of age and c. severely increased proteinuria as defined by i. Urinary protein-to-creatinine ratio (UPCR) of ≥ 0.50 g/g in participants ≥ 2 years with CKD stage 2 and 3 or ii. UPCR ≥ 1.0 g/g for patients < 2 years of age or ≥ 2 years of age and with CKD stage 1\n- Participants must have stable kidney function between screening and D0 defined as: a. For participants with a creatinine of > 0.8 mg/dL at screening: no increase or decrease in eGFR by ≥ 20% at D0 b. For participants with a creatinine of ≤ 0.8 mg/dL at screening: no increase or decrease in creatinine ≥ 0.15 mg/dL at D0.\n- 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\n- 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
- {"criterion_text":"- Planned urological surgery expected to influence renal function\n- 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)\n- Participants with immune-mediated CKD using rituximab, cyclophosphamide, abatacept, or high-dose glucocorticoids (e.g., prednisolone ≥0.5 mg/kg/d), within <6 months prior to screening (low-dose glucocorticoids or a short course of glucocorticoids for, e.g., treatment of an asthma exacerbation are allowed)\n- Children with hemolytic uremic syndrome (HUS) diagnosed ≤6 months prior to screening\n- Patients with nephrotic syndrome receiving albumin infusions within the last 6 months prior to screening\n- Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame\n- Renal allograft in place\n- Bilateral renal artery stenosis\n- Acute kidney injury requiring dialysis within 6 months prior to screening\n- Systemic hypertension stage 2 in children ≥1 year of age defined according to guidelines on blood pressure management at screening or randomization\n- Systolic blood pressure (SBP) above 110 mmHg in infants 6 months to <1 year of age at screening or randomization"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Mean reduction from baseline to Month 6 in Urinary Protein-toCreatinine Ratio (Percent change from baseline to day 180±7 in UPCR)","definition_or_measurement_approach":"Percent change in Urinary Protein-to-Creatinine Ratio (UPCR) from baseline to day 180 ± 7 days (Month 6)."}
Secondary endpoints
- {"endpoint_text":"- Number of participants with a. AEs b. Serious TEAEs c. TEAEs and serious TEAEs leading to discontinuation of treatment d. Study drug related TEAEs and serious TEAEs e. TEAEs categorized by severity f. TEAEs by maximum intensity g. No. of participants hospitalized with hyperkalemia h. No. of participants discontinuing due to hyperkalemia i. No. of participants hospitalization for worsening of renal function j. No. of participants discontinuing due to worsening of renal function","definition_or_measurement_approach":"Safety outcomes captured as counts of adverse events (AEs), treatment-emergent AEs (TEAEs), serious TEAEs, TEAEs leading to discontinuation, study-drug-related events, severity categorisation, and specific event counts for hyperkalemia and worsening renal function (hospitalizations and discontinuations)."}
- {"endpoint_text":"- Change in serum potassium levels, serum creatinine, eGFR and systolic blood pressure from baseline to day 180±7","definition_or_measurement_approach":"Change from baseline to day 180 ± 7 days in serum potassium, serum creatinine, estimated glomerular filtration rate (eGFR) and systolic blood pressure."}
- {"endpoint_text":"- Urinary Protein-to-Creatinine Ratio (UPCR) reduction of at least 30% from baseline to day 180±7 (Proportion of responders at the day 180±7 time point, where a responder is defined as a >=30% reduction in UPCR compared to baseline","definition_or_measurement_approach":"Responder proportion at day 180 ± 7 days defined as participants with ≥30% reduction in UPCR compared with baseline."}
- {"endpoint_text":"- Change in UACR from baseline to day 180±7","definition_or_measurement_approach":"Change from baseline to day 180 ± 7 days in urine albumin-to-creatinine ratio (UACR)."}
- {"endpoint_text":"- PK (finerenone Cmax,md, AUCτ,md) based on total concentrations in plasma","definition_or_measurement_approach":"Pharmacokinetic parameters (finerenone Cmax,md and AUCτ,md) calculated from total plasma concentrations."}
- {"endpoint_text":"- Taste and texture of the pediatric formulation","definition_or_measurement_approach":"Acceptability/palatability assessment of the pediatric formulation (taste and texture) using subject/parent-reported questionnaires."}
Recruitment
- Registry Or Advocacy Recruitment
- True, Conect4children Stichting
- Planned Sample Size
- 261
- Recruitment Window Months
- 65
- Consent Approach
- Informed consent is provided by parent(s)/legal guardian(s); assent is obtained from children where appropriate. Age-specific consent/assent documents are provided (parental ICFs and child assent forms for multiple age bands including 15-17 yrs, 12-14 yrs, 7-11 yrs, pre‑teens, and younger age groups). Documents and ICF/assent materials are available in multiple country/language versions corresponding to participating countries (examples include English, Spanish, French, German, Swedish, Dutch, Italian, Portuguese, Polish, Czech, Hungarian, Lithuanian, Greek, Bulgarian, Finnish, Danish).
Geography
- Total Number Of Sites
- 67
- Total Number Of Participants
- 245
Sweden
- Earliest CTIS Part Ii Submission Date
- 04-03-2024
- Latest Decision Or Authorization Date
- 25-03-2024
- Processing Time Days
- 21
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- 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
- 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
Spain
- Earliest CTIS Part Ii Submission Date
- 04-03-2024
- Latest Decision Or Authorization Date
- 19-03-2024
- Processing Time Days
- 15
- Number Of Sites
- 6
- Number Of Participants
- 22
Sites
- 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
- 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 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
- 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
- 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
- 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
Denmark
- Earliest CTIS Part Ii Submission Date
- 04-03-2024
- Latest Decision Or Authorization Date
- 19-03-2024
- Processing Time Days
- 15
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- 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
- 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
- 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
Belgium
- Earliest CTIS Part Ii Submission Date
- 04-03-2024
- Latest Decision Or Authorization Date
- 27-03-2024
- Processing Time Days
- 23
- Number Of Sites
- 5
- Number Of Participants
- 20
Sites
- 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
- 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
- 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
- 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
- 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
Czechia
- Earliest CTIS Part Ii Submission Date
- 04-03-2024
- Latest Decision Or Authorization Date
- 22-03-2024
- Processing Time Days
- 18
- Number Of Sites
- 2
- Number Of Participants
- 8
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
France
- Earliest CTIS Part Ii Submission Date
- 04-03-2024
- Latest Decision Or Authorization Date
- 21-03-2024
- Processing Time Days
- 17
- Number Of Sites
- 6
- Number Of Participants
- 25
Sites
- 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
- 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 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
- 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
- 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
Finland
- Earliest CTIS Part Ii Submission Date
- 04-03-2024
- Latest Decision Or Authorization Date
- 20-03-2024
- Processing Time Days
- 16
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- 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
- 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
Poland
- Earliest CTIS Part Ii Submission Date
- 04-03-2024
- Latest Decision Or Authorization Date
- 25-03-2024
- Processing Time Days
- 21
- Number Of Sites
- 4
- Number Of Participants
- 20
Sites
- Site Name
- Instytut Pomnik Centrum Zdrowia Dziecka
- Department Name
- Klinika Nefrologii, Transplantacji Nerek i Nadcisnienia Tetniczego
- Principal Investigator Name
- Mieczyslaw Litwin
- Principal Investigator Email
- oddzial.nefrologia@ipczd.pl
- Contact Person Name
- Mieczyslaw Litwin
- Contact Person Email
- oddzial.nefrologia@ipczd.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
- 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
- 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
Italy
- Earliest CTIS Part Ii Submission Date
- 04-03-2024
- Latest Decision Or Authorization Date
- 21-03-2024
- Processing Time Days
- 17
- Number Of Sites
- 6
- Number Of Participants
- 20
Sites
- 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 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
- Enrico Verrina
- Principal Investigator Email
- enricoverrina@gaslini.org
- Contact Person Name
- Enrico Verrina
- Contact Person Email
- enricoverrina@gaslini.org
- 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 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
Germany
- Earliest CTIS Part Ii Submission Date
- 04-03-2024
- Latest Decision Or Authorization Date
- 20-03-2024
- Processing Time Days
- 16
- Number Of Sites
- 7
- Number Of Participants
- 24
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
- Kindernierenzentrum Bonn
- Department Name
- Not Applicable
- 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
- 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
- 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
- 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
Austria
- Earliest CTIS Part Ii Submission Date
- 04-03-2024
- Latest Decision Or Authorization Date
- 16-04-2024
- Processing Time Days
- 43
- Number Of Sites
- 4
- Number Of Participants
- 10
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
- 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
- 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
- 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
Netherlands
- Earliest CTIS Part Ii Submission Date
- 04-03-2024
- Latest Decision Or Authorization Date
- 19-03-2024
- Processing Time Days
- 15
- Number Of Sites
- 2
- Number Of Participants
- 12
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
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 20-10-2025
- Latest Decision Or Authorization Date
- 24-11-2025
- Processing Time Days
- 35
- Number Of Sites
- 3
- Number Of Participants
- 14
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
Portugal
- Earliest CTIS Part Ii Submission Date
- 04-03-2024
- Latest Decision Or Authorization Date
- 18-03-2024
- Processing Time Days
- 14
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Centro Hospitalar Universitario De Santo Antonio E.P.E.
- Department Name
- Pediatrics
- 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
- 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
Lithuania
- Earliest CTIS Part Ii Submission Date
- 04-03-2024
- Latest Decision Or Authorization Date
- 28-03-2024
- Processing Time Days
- 24
- Number Of Sites
- 2
- Number Of Participants
- 15
Sites
- 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
- 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
Hungary
- Earliest CTIS Part Ii Submission Date
- 04-03-2024
- Latest Decision Or Authorization Date
- 20-03-2024
- Processing Time Days
- 16
- Number Of Sites
- 4
- Number Of Participants
- 13
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 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
- 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
Greece
- Earliest CTIS Part Ii Submission Date
- 04-03-2024
- Latest Decision Or Authorization Date
- 03-06-2024
- Processing Time Days
- 91
- Number Of Sites
- 5
- Number Of Participants
- 20
Sites
- 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
- 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
- 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
- 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 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
- PRA Hellas CRO A.E.
- Responsibilities
- Clinical Trial duties in Greece
- Name
- Icon Clinical Research Limited
- Responsibilities
- Clinical Trial duties in Greece
Third parties
- {"country":"Germany","full_name":"Universitaetsklinikum Heidelberg AöR","duties_or_roles":"Escape - Clinical Research Network","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"Clinical Trial duties in Greece","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Central Read (Cardiac Safety and Imaging)","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Clinical Trial duties in Greece","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Swiss BioQuant AG","duties_or_roles":"Analytical laboratory services (sponsor duties code 4)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Netherlands","full_name":"Conect4children Stichting","duties_or_roles":"Project Management","organisation_type":"Health care"}
- {"country":"Germany","full_name":"DATAN Analytics GmbH","duties_or_roles":"Data analytics (sponsor duties code 10)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"Clinical trial technology/vendor support","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central laboratory services (sponsor duties code 4)","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Competitive Drug Development International Limited","duties_or_roles":"Project Management","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Illingworth Research Group Limited","duties_or_roles":"Home Nursing","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Switzerland","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"Logistics/clinical supplies (sponsor duties code 14)","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- BAY 94-8862
- Active Substance
- FINERENONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Maximum Dose
- 20 mg (maxDailyDoseAmount 20)
- Investigational Product Name
- BAY 948862
- Active Substance
- FINERENONE
- Modality
- Small Molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Maximum Dose
- 20 mg (maxDailyDoseAmount 20)
- Investigational Product Name
- Finerenone
- Active Substance
- FINERENONE
- Modality
- Small Molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Maximum Dose
- 10 mg (maxDailyDoseAmount 10)
- Combination Treatment
- Yes
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