A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria
FIONA OLE
An 18-month, Open-label, Single-arm Safety Extension Study of an age-and Bodyweight-adjusted Oral Finerenone Regimen, in Addition to an ACEI or ARB, for the Treatment of Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria
3 other identifiers
interventional
100
30 countries
175
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 help improve kidney function by reducing the activity of the renin-angiotensin-aldosterone system (RAAS). The RAAS is a system that works with the kidneys to control blood pressure and the balance of fluid and electrolytes in the blood. In people with CKD, the RAAS is often too active, which can impair the ability of the kidneys to work properly and cause hypertension and proteinuria. However, ACEI or ARB treatment alone does not work for all patients with CKD as they only target the angiotensin part of the renin-angiotensin-aldosterone system. The study treatment, finerenone, is expected to help control RAAS overactivation together with an ACEI or ARB. So, the researchers in this study want to learn more about whether finerenone given in addition to either an ACEI or ARB can help their kidney function. The main purpose of this study is to learn how safe the treatment is when used of finerenone in addition to an ACEI or ARB in long-term. To see how safe the treatment is, the study team will collect information on medical problems which are also known as "treatment emergent adverse events" (TEAEs). And they will also collect levels of an electrolyte called potassium in the blood by taking blood samples, and measure blood pressure during the study. The secondary purpose of this study is to learn how well long-term use of finerenone can reduce the amount of protein in the participants' urine and benefit kidney function when taken with standard of care. To see how the treatment works, the study team will collect participants' urine samples to assess urinary albumin-to-creatinine ratio (UACR) and urinary protein-to-creatinine ratio (UPCR), which are important assessments for calculating the level of protein in the urine. Researchers will also collect blood samples to analyze serum creatinine and calculate estimated glomerular filtration rate (eGFR). A significant decline in eGFR indicates worsening kidney function. The study will include participants who had previously participated in FIONA study (NCT05196035). The participants will be aged from 1 year up to 18 years. The participants will be in the study for approximately 19 months. They will take study treatment for up to 18 months and will be follow up for 1 month. During this period, at least 12 visits are planned for patients who newly start finerenone, and at least 8 visits for patients who already received finerenone. In the visit, the study team will:
- have their blood pressure, heart rate, temperature, height and weight measured
- have blood and urine samples taken
- have physical examinations
- have their heart examined by an electrocardiogram and echocardiography (a sonogram of the heart)
- answer questions about their medication and whether they have any adverse events, or have their parents or guardian's answer
- answer questions about how they are feeling, or have their parents or guardian's answer
- answer question about how they like the study medication, or have their parents or guardian's answer The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The doctors will check the participants' health about 30 days after the participants take their last treatment.
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 Nov 2022
Longer than P75 for phase_3
175 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
July 11, 2022
CompletedFirst Posted
Study publicly available on registry
July 13, 2022
CompletedStudy Start
First participant enrolled
November 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 27, 2029
April 14, 2026
April 1, 2026
6.2 years
July 11, 2022
April 13, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Number of participants with treatment emergent adverse event (TEAEs)
Up to 550 days
Change in serum potassium levels from baseline to Day 540±7
Up to 547 days
Change in systolic blood pressure (SBP) from baseline to Day 540±7
Up to 547 days
Secondary Outcomes (3)
Change in urinary protein-to-creatinine ratio (UPCR) from baseline to Day 540±7
Up to 547 days
Change in urinary albumin-to-creatinine ratio (UACR) from baseline to Day 540±7
Up to 547 days
Change in estimated glomerular filtration rate (eGFR) from baseline to Day 540±7
Up to 547 days
Study Arms (1)
Finerenone Open-Label safety Extension
EXPERIMENTALParticipants will receive finerenone treatment.
Interventions
Finerenone in different doses, treatment duration will be 540 ±7 days.
Eligibility Criteria
You may qualify if:
- Participants must be ≥1 year to 18 years of age, at the time of signing the informed consent/assent.
- Prior participation in the finerenone Phase 3 study FIONA (19920) and not permanently discontinued from treatment by the end of treatment (EoT) visit in FIONA.
- Participants must have a clinical diagnosis of chronic kidney disease (CKD) at Visit 1 which is defined as
- CKD stages 1-3 (estimated glomerular filtration rate \[eGFR\] ≥30 mL/min/1.73m\^2) for children ≥1 year to \<19 years of age at FIONA EoT and at Visit 1
- Treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at optimized doses defined as maximally tolerable doses within the recommended dose range according to guidelines on blood pressure (BP) management, unchanged for at least 30 days prior to Visit 1.
- K+ ≤5.0 mmol/L for children ≥2 years of age at both FIONA EoT and Visit 1, and ≤5.3 mmol/L for children \<2 years of age at both FIONA EoT and Visit 1
- Participants who have reached legal age of consent: Capable of giving signed informed consent.
- Participant is able to receive enteral feeding (solid food, bottle or cup fed, feeding through nasogastric or gastric feeding tubes) with or without breastfeeding.
You may not qualify if:
- Planned urological surgery expected to influence renal function
- Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame
- Systemic hypertension Stage 2 defined according to institutional guidelines on BP management at Visit 1.
- Systemic hypotension defined as symptomatic hypotension or a mean systolic BP below the 5th percentile for age, sex and height but no lower than 80 mmHg for participants \<18 years and symptomatic hypotension or a mean systolic blood pressure (SBP) \<90 mmHg in participants ≥18 years at Visit 1.
- Known hypersensitivity to the study treatment (active substance or excipients)
- Severe hepatic insufficiency defined by e.g. Child-Pugh C or analogous scores.
- Participants using rituximab, cyclophosphamide, abatacept, or intravenous glucocorticoids
- Concomitant therapy with a mineralocorticoid receptor antagonist (MRA)(eplerenone, spironolactone, esaxerenone, canrenone), any renin inhibitor (aliskiren, enalkiren, remikiren), any sodium-glucose co-transporter-2 (SGLT2) inhibitor (SGLT2i), sacubitril/valsartan combination (ARNI), or potassium-sparing diuretic (amiloride, triamterene)
- Concomitant therapy with both ACEI and ARBs together
- Concomitant therapy with strong cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, moderate or strong CYP3A4 inducers
- Previous assignment to treatment during this study
- Simultaneous participation in another interventional clinical study (e.g., Phase 1 to 4 clinical studies).
- Any suspected (serious) adverse event related to study intervention which led to permanent discontinuation during the FIONA study.
- Pregnant or breastfeeding or intention to become pregnant during the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (178)
Phoenix Children's Hospital | Main - Transplant Department
Phoenix, Arizona, 85016, United States
Cedars-Sinai Samuel Oschin Cancer Center
Los Angeles, California, 90048, United States
Lucille Packard Children's Hospital Stanford - Pediatric Nephrology
Palo Alto, California, 94304, United States
Rady Children's Hospital San Diego - Cardiology
San Diego, California, 92123, 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
OHSU Doernbecher Children's Hospital - Neurology
Portland, Oregon, 97239, United States
Children's Hospital of Philadelphia - Nephrology
Philadelphia, Pennsylvania, 19104, United States
University Hospital - San Antonio - Pediatric Nephrology
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
Hospital de Niños Sor María Ludovica
La Plata, Buenos Aires, 1900, 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 Italiano de Buenos Aires
Buenos Aires, C1199ABB, Argentina
Hospital de Pediatría Juan P. Garrahan
Buenos Aires, C1249ABN, Argentina
Hospital General de Ninos Pedro de Elizalde | Nephrology Department
Ciudad Autonoma de Buenos Aire, C1270AAN, Argentina
Many Locations
Multiple Locations, Argentina
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
Universitätsklinikum AKH Wien
Vienna, State of Vienna, 1090, Austria
Medizinische Universität Graz
Graz, Styria, 8036, Austria
Kepler Universitätsklinikum Campus IV
Innsbruck, Tyrol, 6020, Austria
Many Locations
Multiple Locations, 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
Many Locations
Multiple Locations, 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
The Hospital for Sick Children (SickKids)
Toronto, Ontario, M5G 1X8, Canada
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
Many Locations
Multiple Locations, Czechia
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
Many Locations
Multiple Locations, 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
Many Locations
Multiple Locations, 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, Nouvelle-Aquitaine, 33076, France
Hopital Arnaud de Villeneuve CHU Montpellier
Montpellier, Occitanie, 34059, France
Hôpital des Enfants
Toulouse, Occitanie, 31059, France
Many Locations
Multiple Locations, 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) | Zentrum Innere Medizin | Klinik fuer Kardiologie und Angiologie
Hanover, Lower Saxony, 30625, Germany
Kindernierenzentrum Bonn
Bonn, North Rhine-Westphalia, 53127, 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
Many Locations
Multiple Locations, 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
Many Locations
Multiple Locations, 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
Many Locations
Multiple Locations, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, 7623, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, 6720, Hungary
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
Clalit Health | Soroka Medical Center - Internal Medicine Department
Beersheba, 8410101, Israel
Wilf Children's Hospital Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Many Locations
Multiple Locations, 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
Many Locations
Multiple Locations, 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
Many Locations
Multiple Locations, 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
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 Universitario "José Eleuterio González"
Monterrey, Nuevo León, 64460, Mexico
Instituto Veracruzano en Investigación Clinica SC
Veracruz, 91900, Mexico
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ, Netherlands
Many Locations
Multiple Locations, 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
Many Locations
Multiple Locations, Poland
Instytut "Pomnik - Centrum Zdrowia Dziecka"
Warsaw, 04-730, Poland
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego 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
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
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 3080, South Korea
Many Locations
Multiple Locations, South Korea
Korea University Guro Hospital
Seoul, 152-703, 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
Many Locations
Multiple Locations, Spain
Hospital Universitario Virgen Del Rocio S.L. | Nefrologia pediatrica
Seville, 41013, Spain
Skåne University Hospital
Lund, Skåne County, 22242, Sweden
Karolinska University Hospital
Stockholm, Stockholm County, 141 86, Sweden
Uppsala University Hospital
Uppsala, Uppsala County, 751 85, Sweden
Many Locations
Multiple Locations, 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
Many Locations
Multiple Locations, 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)
Many Locations
Multiple Locations, 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
Many Locations
Multiple Locations, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2022
First Posted
July 13, 2022
Study Start
November 8, 2022
Primary Completion (Estimated)
January 28, 2029
Study Completion (Estimated)
February 27, 2029
Last Updated
April 14, 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.