A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria
FIONA
A 6-month Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and PK/PD of an age-and Body Weight-adjusted Oral Finerenone Regimen, in Addition to an ACEI or ARB, for the Treatment of Children, 6 Months to <18 Years of Age, With Chronic Kidney Disease and Proteinuria
3 other identifiers
interventional
219
31 countries
160
Brief Summary
Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine. The kidneys filter waste and fluid from the blood to form urine. In children with CKD, the kidney´s filters do not work as well as they should. This can lead to accumulation of waste and fluid in the body and proteinuria. CKD can lead to other medical problems, such as high blood pressure, also known as hypertension. Vice versa, hypertension and proteinuria can also contribute to worsening of CKD. Therefore, the treatment of CKD aims to control blood pressure and proteinuria. There are treatments available for doctors to prescribe to children with CKD and hypertension and/or proteinuria. These include "angiotensin-converting enzyme inhibitors" (ACEI) and "angiotensin receptor blockers" (ARB). Both ACEI and ARB can improve kidney function by helping the renin-angiotensin-aldosterone system (RAAS) to work normally. The RAAS is a system that works with the kidneys to control blood pressure and the balance of fluid and electrolytes in the blood. In people with CKD, the RAAS is often too active, which can stop the kidneys from working properly and cause hypertension and proteinuria. However, ACEI or ARB treatment alone does not work for all patients with CKD as they only target the angiotensin part of the renin-angiotensin-aldosterone system. The study treatment, finerenone, is expected to help control RAAS overactivation together with an ACEI or ARB. So, the researchers in this study want to learn more about whether finerenone given in addition to either an ACEI or ARB can help their kidney function. The main purpose of this study is to learn more about whether finerenone added to either ACEI or ARB can help reduce the amount of protein in the participants' urine more than a placebo. A placebo looks like a treatment but does not have any medicine in it. Participants will also continue to receive their other medications. To see how the treatment work, the doctors will take samples of the participants' urine to measure their protein levels before and during taking treatment and after their last treatment. In addition, blood samples will be taken to monitor kidney function, electrolytes and the amount of finerenone in the blood as well as for other tests. This study will include children with CKD and proteinuria aged from 6 months up to less than 18 years. The participants will take:
- either finerenone or the placebo, in addition to
- either ACEI or ARB, whichever they take as part of their normal treatment Two visits are required up to 104 days, to check whether a child can take part in the treatment phase of the study. If participants qualify for the treatment phase, they will then undergo treatment for about 180 days. During this time, they will visit the study site at least 7 times. During these visits, the participants will:
- have their blood pressure, heart rate, temperature, height and weight measured
- have blood and urine samples taken
- have physical examinations
- have their heart examined by an electrocardiogram and echocardiography (a sonogram of the heart)
- answer questions about their medication and whether they have any adverse events , or have their parents or guardians answer
- answer questions about how they are feeling, or have their parents or guardians answer
- answer question about how they like the study medication, or have their parents or guardians answer The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The doctors will check the participants' health about 30 days after the participants take their last treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2022
Longer than P75 for phase_3
160 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2022
CompletedFirst Posted
Study publicly available on registry
January 19, 2022
CompletedStudy Start
First participant enrolled
March 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
April 17, 2026
April 1, 2026
5.3 years
January 7, 2022
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percent change in Urinary protein-to-creatinine ratio (UPCR) reduction from baseline to day 180+/-7
Percent change from baseline to day 180±7 in UPCR will be calculated.
From baseline to day 180+/-7
Secondary Outcomes (10)
Number participants with treatment emergent adverse events (TEAEs）
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
From baseline to day 180±7
Change in systolic blood pressure from baseline to day 180±7
From baseline to day 180±7
- +5 more secondary outcomes
Study Arms (2)
Finerenone (Kerendia, BAY94-8862)
EXPERIMENTALParticipants will receive finerenone treatment.
Placebo
PLACEBO COMPARATORParticipants will receive placebo to finerenone.
Interventions
Finerenone in different doses, treatment duration will be 180±7 days
Eligibility Criteria
You may qualify if:
- Participants must be 6 months to \<18 years old at the time when the informed consent/assent is signed
- Participants must have a clinical diagnosis of chronic kidney disease (CKD) at screening which is defined as
- CKD stages 1-3 (eGFR ≥30 mL/min/1.73m\^2) for children ≥1 year to \<18 years of age or
- a serum creatinine ≤ 0.40 mg/dL for infants 6 months to \< 1 year of age and
- severely increased proteinuria as defined by
- Urinary protein-to-creatinine ratio (UPCR) of ≥ 0.50 g/g in participants ≥ 2 years with CKD stage 2 and 3 or
- UPCR ≥ 1.0 g/g for patients \< 2 years of age or ≥ 2 years of age and with CKD stage 1
- Participants must have stable kidney function between screening and D0 defined as:
- For participants with a creatinine of \> 0.8 mg/dL at screening: no increase or decrease in eGFR by ≥ 20% at D0
- For participants with a creatinine of ≤ 0.8 mg/dL at screening: no increase or decrease in creatinine ≥ 0.15 mg/dL at D0.
- Treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at optimized doses defined as maximally tolerable doses within the recommended dose range according to guidelines on blood pressure management, unchanged for at least 30 days prior to screening
- K+ ≤5.0 mmol/L for children ≥2 years of age at both screening and D0, and ≤5.3 mmol/L for children \<2 years of age at both screening and D0
You may not qualify if:
- Planned urological surgery expected to influence renal function
- Children with hemolytic uremic syndrome (HUS) diagnosed ≤6 months prior to screening
- Patients with nephrotic syndrome receiving albumin infusions within the last 6 months prior to screening
- Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame
- Renal allograft in place
- Bilateral renal artery stenosis
- Acute kidney injury requiring dialysis within 6 months prior to screening
- Systemic hypertension stage 2 in children ≥1 year of age defined according to guidelines on blood pressure management at screening or randomization
- Systolic blood pressure (SBP) above 110 mmHg in infants 6 months to \<1 year of age at screening or randomization
- Systemic hypotension defined as a systolic blood pressure below the 5th percentile for age, sex and height at either screening or randomization but no lower than 80 mmHg (although for some participants the 5th percentile of SBP is \< 80 mmHg they must be excluded if their SBP is \<80 mmHg)
- Participants with immune-mediated CKD using rituximab, cyclophosphamide, abatacept, or high-dose glucocorticoids, within \<6 months prior to screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (164)
Phoenix Children's Hospital | Main - Transplant Department
Phoenix, Arizona, 85016, United States
Cedars-Sinai Medical Center - Nephrology
Los Angeles, California, 90048, United States
Lucille Packard Children's Hospital Stanford - Pediatric Nephrology
Palo Alto, California, 94304, United States
UC San Diego - Altman Clinical and Translational Research Institute (ACTRI) - Linda Vista Clinic
San Diego, California, 92023, United States
Children's National Hospital - Nephrology
Washington D.C., District of Columbia, 20010, United States
Memorial Transplant Institute - Pediatric Nephrology
Hollywood, Florida, 33021, United States
Emory University Hospital/Children's Healthcare of Atlanta - Nephrology
Atlanta, Georgia, 30322, United States
University of Iowa Health Care Medical Center - Nephrology
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
OHSU Doernbecher Children's Hospital - Neurology
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
Eccles Primary Children's Outpatient Services - Nephrology
Salt Lake City, Utah, 84113, United States
Seattle Children's Hospital - Nephrology
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, San Luis Province, D5700CGR, Argentina
Clinica de Nefrologia, Urologia y Enfermedades Cardiovascualares | Santa Fe, Argentina
Santa Fe, Santa Fe Province, 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
Uniklinikum Salzburg - Landeskrankenhaus
Vienna, State of Vienna, 1090, Austria
Medizinische Univ Graz | Kinder & Jugendheilkunde
Graz, Styria, 8036, Austria
Kepler Universitätsklinikum Campus IV
Innsbruck, Tyrol, 6020, Austria
AKH Wien | Kinder & Jugendheilkunde, Kindernephrologie
Vienna, Vorarlberg, 6800, Austria
Huderf / Ukzkf
Bruxelles - Brussel, 1020, Belgium
CU Saint-Luc/UZ St-Luc
Bruxelles - Brussel, 1200, Belgium
UZ Gent
Ghent, 9000, Belgium
UZ Gasthuisberg - Pediatric Nephrology
Leuven, 3000, Belgium
CHC Montlégia - Pediatrics
Liège, 4000, Belgium
Hospital Pequeno Principe
Curitiba, Paraná, 80250-060, Brazil
Hosp Clínicas Facult. Med. de Ribeirão Preto / USP
Ribeirão Preto, São Paulo, 14051-140, Brazil
Hospital Infantil Sabará - Instituto PENSI - Pesquisa e Ensino em Saúde Infantil
São Paulo, São Paulo, 01227-200, Brazil
Instituto da Crianca e do Adolescente
São Paulo, São Paulo, 05403 000, Brazil
Hospital PUC-Campinas | Centro de Pesquisa Clínica Sao Lucas
São Paulo, São Paulo, 13034-685, Brazil
Santa Casa de Misericórdia de Belo Horizonte
São Paulo, São Paulo, 30150-221, Brazil
UMHAT Sveti Georgi
Plovdiv, Plovdiv Province, 4002, Bulgaria
SHATPD "Prof. Ivan Mitev"
Sofia, Sofia City Province, 1606, Bulgaria
MHAT prof. Stoyan Kirkovitch AD
Stara Zagora, Stara Zagora Province, 6003, Bulgaria
Alberta Children's Hospital | Nephrology Clinic
Calgary, Alberta, T3B 6A8, Canada
McMaster University Medical Centre | McMaster Children's Hospital | Cardiology
Hamilton, Ontario, L8N 3Z5, Canada
The Hospital for Sick Children (SickKids)
Toronto, Ontario, M5G 1X8, Canada
Centre hospitalier universitaire Sainte-Justine | Cardiology
Montreal, Quebec, H3T 1C5, Canada
Všeobecná fakultní nemocnice v Praze
Prague, 128 08, Czechia
Fakultní nemocnice Motol a Homolka, Pracovište MOTOL
Prague, 150 06, Czechia
Rigshospitalet - Børn og Unge
Copenhagen, Capital Region, 2100, Denmark
Aarhus Universitetshospital - Børn og Unge
Aarhus N, Central Jutland, 8200, Denmark
Odense Universitetshospital - HC Andersen Børne og Ungehospital
Odense, Region Syddanmark, 5000, Denmark
Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS) - Lasten lääketutkimuskeskus PeeTU
Tampere, Pirkanmaa, 33521, Finland
Turun yliopistollinen keskussairaala
Turku, Southwest Finland, 20520, Finland
HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Uusi lastensairaala, nefrologia
Helsinki, Uusimaa, 00290, Finland
CHU de Lyon - Hopital Femme Mère Enfant
Bron, Auvergne-Rhône-Alpes, 69677, France
CHU Strasbourg - Hopital Hautepierre
Strasbourg, Grand Est, 67200, France
CHU bordeaux - Hopital Pellegrin
Bordeaux, New Aquitaine, 33076, France
Hopital Arnaud de Villeneuve CHU Montpellier
Montpellier, Occitanie, 34059, France
Hôpital des Enfants
Toulouse, Occitanie, 31059, France
Hopital Robert Debre
Paris, Île-de-France Region, 75019, France
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69115, Germany
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054, Germany
Medizinische Hochschule Hannover (MHH)
Hanover, Lower Saxony, 30625, Germany
Kindernierenzentrum Bonn
Bonn, North Rhine-Westphalia, 53127, Germany
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, 45147, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149, Germany
Charité / Pädiatrie
Berlin, 13353, Germany
Universitätsklinikum Hamburg Eppendorf (UKE)
Hamburg, 20246, Germany
Children's Hospital of Athens P&A Kyriakou - Pediatric Nephrology Department
Athens, 11526, Greece
Children's Hospital of Athens Agia Sofia - Pediatric Nephrology Department
Athens, 11527, Greece
University General Hospital of Heraklion
Heraklion, 71110, Greece
University General Hospital Of Ioannina-Child Health Sector
Ioannina, 45500, Greece
Ippokratio General Hospital Of Thessaloniki-Pediatric Nephrology Unit, 3rd Department of Paediatrics
Thessaloniki, 54642, Greece
Semmelweis University
Budapest, 1083, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, 7623, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, 6720, Hungary
Institute of Kidney Diseases and Research Center Gujarat University of Transplantation Sciences
Ahmedabad, Gujarat, 380016, India
Mavani Kidney Care
Ahmedabad, Gujarat, 380052, India
St. John's National Academy of Health Sciences
Bengaluru, Karnataka, 560034, India
All India Institute of Medical Sciences (AIIMS) - New Delhi
Delhi, National Capital Territory of Delhi, 110029, India
NRS Medical college
Kolkata, West Bengal, 700014, India
Post Graduate Institute of Medical Education and Research
Chandigarh, 160012, India
Clalit Health | Soroka Medical Center - Internal Medicine Department
Beersheba, 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
Petah 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
Rome, Lazio, 00165, Italy
IRCCS Istituto Giannina Gaslini - Nefrologia e Trapianto Rene
Genoa, Liguria, 16147, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Nefrologia e Dialisi Pediatrica, Trapianti di Rene
Milan, Lombardy, 20122, Italy
Azienda Ospedaliera Universitaria Meyer IRCCS - Nefrologia e Dialisi
Florence, 50139, Italy
A.O.U. Città della Salute e della Scienza di Torino_Regina Margherita - Nefrologia Pediatrica
Torino, 10126, Italy
Hospital of LT University of Health Sciences Kaunas Clinics
Kaunas, LT-50161, Lithuania
Klaipeda Children's Hospital
Klaipėda, LT-92140, Lithuania
Vilnius University Hospital Santaros Klinikos Children's Hospital Paediatrics Centre
Vilnius, LT-08406, Lithuania
Hospital Universiti Sains Malaysia
Kelantan, Kelantan, 16150, Malaysia
Hospital Tunku Azizah
Wilayah Persekutuan Putrajaya, 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
Sitio Alfredo Chew Wong | Aguascalientes, Mexico
Aguascalientes, Agguascalientes, 20124, Mexico
Instituto Veracruzano en Investigación Clinica SC
Mexico City, Mexico City, 11850, Mexico
Hospital Infantil de México "Dr. Federico Gómez"
México D.F., Mexico City, 6720, Mexico
Instituto Nacional de Pediatría
México, D.F., Mexico City, 4530, Mexico
Hospital Universitrio Dr. José Eleuterio González. Servicio de Oncologia
Nuevo León, Monterrey, 64460, Mexico
Hospital Regional de Alta Especialidad Ixtapaluca
Ixtapaluca, State of Mexico, 56530., Mexico
Universitair Medisch Centrum St. Radboud
Nijmegen, Gelderland, 6525 GA, Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ, 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
Warsaw, 02-091, Poland
Instytut "Pomnik - Centrum Zdrowia Dziecka"
Warsaw, 04-730, Poland
Uniwersytecki Szpital Kliniczny UM we Wroclawiu
Wroclaw, 50-556, Poland
Centro Clinico Academico Braga | Braga, Portugal
Braga, 4710-243, Portugal
Hospital Pediátrico de Coimbra I ULS Coimbra
Coimbra, 3000, Portugal
Hospital Santa Maria | Centro de Investigacao Clinica
Lisbon, 1649-035, Portugal
Unidade Local de Saúde de Santo António, E.P.E
Porto, 4050-651, Portugal
Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit
Soweto, Gauteng, 1862, South Africa
Kyungpook National University Hospital
Daegu, Daegu Gwang''yeogsi, 41944, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, 13620, South Korea
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612, South Korea
Korea University Guro Hospital
Seoul, Seoul Teugbyeolsi, 152-703, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 3080, South Korea
Hospital Universitari Vall D Hebron | Nefrologia pediatrica
Barcelona, 08035, Spain
Hospital Sant Joan De Deu Barcelona | Nefrologia pediatrica
Barcelona, 08950, Spain
Hospital Universitario 12 De Octubre | Nefrologia pediatrica
Madrid, 28041, Spain
Hospital Universitario La Paz | Nefrologia pediatrica
Madrid, 28046, Spain
Hospital Universitario Regional De Malaga | Nefrologia pediatrica
Málaga, 29010, Spain
Hospital Universitario Virgen Del Rocio S.L. | Nefrologia pediatrica
Seville, 41013, Spain
Skånes Universitetssjukhus Lund - Barnnefroenheten
Lund, Skåne County, 221 85, Sweden
Karolinska University Hospital
Stockholm, Stockholm County, 141 86, Sweden
OBSOLETE_Uppsala University Hospital
Uppsala, Uppsala County, 751 85, Sweden
Universitäts-Kinderspital UKBB
Basel, Canton of Basel-City, 4031, Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1012, Switzerland
Hopital des Enfants HUG
Geneva, 1211, Switzerland
Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch
Guishan, Taoyuan, 83301, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, 813414, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 100229, Taiwan
Chang Gung Memorial Hospital at Linkou
Taipei, 10507, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Cukurova Univ. Tip. Fak. Balcali Hastanesi
Adana, 01790, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi
Ankara, 06230, Turkey (Türkiye)
Baskent Universitesi Tip Fakultesi Hastanesi
Ankara, 6490, Turkey (Türkiye)
Gazi Universitesi Tip Fakultesi
Ankara, 6560, Turkey (Türkiye)
T.C. Saglik Bakanligi Ankara Bilkent Sehir Hastanesi Noroloji ve Ortopedi Hastanesi Noroloji Bolumu
Ankara, 6800, Turkey (Türkiye)
Istanbul Faculty of Medicine, Department of Internal Medicine, Department of Pediatrics
Istanbul, 34093, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa - Cocuk Nefrolojisi
Istanbul, 34098, Turkey (Türkiye)
Marmara University Medical Faculty | Pediatric Nephrology
Istanbul, 34899, Turkey (Türkiye)
Great Ormond Street Hospital for Children NHS Foundation Trust | Great Ormond Street Hospital - Clinical Research Facility
London, Greater London, WC1N 3JH, United Kingdom
Manchester University NHS Foundation Trust | Royal Manchester Children's Hospital - Clinical Research Facility
Manchester, Greater Manchester, M13 9WL, United Kingdom
Nottingham University Hospitals NHS Trust | Queens Medical Centre - Childrens Clinical Research Facility
Nottingham, Nottinghamshire, NG7 2UH, United Kingdom
NHS Greater Glasgow and Clyde | Royal Hospital for Children - Glasgow Clinical Research Facility
Glasgow, Scotland, G51 4TF, United Kingdom
Birmingham Children's Hospital
Birmingham, West Midlands, B4 6NH, United Kingdom
Related Publications (1)
Schaefer F, Montini G, Kang HG, Walle JV, Zaritsky J, Schreuder MF, Litwin M, Scalise A, Scott H, Potts J, Iveli P, Breitenstein S, Warady BA. Investigating the use of finerenone in children with chronic kidney disease and proteinuria: design of the FIONA and open-label extension studies. Trials. 2024 Mar 21;25(1):203. doi: 10.1186/s13063-024-08021-z.
PMID: 38509517DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2022
First Posted
January 19, 2022
Study Start
March 28, 2022
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
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.