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
- Conditions
- ProteinuriaChronic Kidney DiseaseChildren
- Interventions
- Registration Number
- NCT05457283
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
-
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Finerenone Open-Label safety Extension Finerenone (Kerendia, BAY94-8862) Participants will receive finerenone treatment.
- Primary Outcome Measures
Name Time Method Change in systolic blood pressure (SBP) from baseline to Day 540±7 Up to 547 days 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
- Secondary Outcome Measures
Name Time Method Change in estimated glomerular filtration rate (eGFR) from baseline to Day 540±7 Up to 547 days 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
Trial Locations
- Locations (140)
Cedars-Sinai Samuel Oschin Cancer Center
🇺🇸Los Angeles, California, United States
OHSU Doernbecher Children's Hospital - Neurology
🇺🇸Portland, Oregon, United States
Sitio Alfredo Chew Wong | Aguascalientes, Mexico
🇲🇽Aguascalientes, Agguascalientes, Mexico
Hospital Infantil de México "Dr. Federico Gómez"
🇲🇽México D.F., Distrito Federal, Mexico
Instituto Nacional de Pediatría
🇲🇽México, D.F., Distrito Federal, Mexico
Hospital Universitario "José Eleuterio González"
🇲🇽Monterrey, Nuevo Leon, Mexico
Instituto Veracruzano en Investigación Clinica SC
🇲🇽Veracruz, Mexico
Phoenix Children's Hospital | Main - Transplant Department
🇺🇸Phoenix, Arizona, United States
University of California San Diego (UCSD)
🇺🇸La Jolla, California, United States
Lucille Packard Children's Hospital Stanford - Pediatric Nephrology
🇺🇸Palo Alto, California, United States
Children's National Medical Center - Nephrology
🇺🇸Washington, District of Columbia, United States
South Broward Hosp. District dba Memorial Healthcare System
🇺🇸Hollywood, Florida, United States
Emory University Hospital/Children's Healthcare of Atlanta - Nephrology
🇺🇸Atlanta, Georgia, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
The Charlotte R. Bloomberg Children's Center Building - Nephrology
🇺🇸Baltimore, Maryland, United States
Boston Children's Hospital - Main Campus - Nephrology
🇺🇸Boston, Massachusetts, United States
Children's Mercy Hospital Kansas City - Nephrology
🇺🇸Kansas City, Missouri, United States
Cincinnati Children's Hospital Medical Center | Division of Nephrology and Hypertension
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic | Pediatric Nephrology
🇺🇸Cleveland, Ohio, United States
Children's Hospital of Philadelphia - Nephrology
🇺🇸Philadelphia, Pennsylvania, United States
Univ of Texas Health Science Center | Nephrology Res Dept
🇺🇸San Antonio, Texas, United States
Primary Children's Hospital
🇺🇸Salt Lake City, Utah, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Hospital de Niños Sor María Ludovica
🇦🇷La Plata, Buenos Aires, Argentina
Hospital General de Ninos Ricardo Gutierrez | Pediatric Nephrology Department
🇦🇷Ciudad Autónoma de Buenos Aire, Ciudad Auton. De Buenos Aires, Argentina
Centro de Rehabilitacion Cardiovascular | San Luis, Argentina
🇦🇷San Luis, Provincia De San Luis, Argentina
Clinica de Nefrologia, Urologia y Enfermedades Cardiovascualares | Santa Fe, Argentina
🇦🇷Santa Fe, Provincia De Santa Fe, Argentina
Hospital Italiano de Buenos Aires
🇦🇷Buenos Aires, Argentina
Hospital de Pediatría Juan P. Garrahan
🇦🇷Buenos Aires, Argentina
Hospital General de Ninos Pedro de Elizalde | Nephrology Department
🇦🇷Ciudad Autonoma de Buenos Aire, Argentina
Many Locations
🇬🇧Multiple Locations, United Kingdom
Queensland Children's Hospital
🇦🇺South Brisbane, Queensland, Australia
Monash Children's Hospital
🇦🇺Clayton, Victoria, Australia
Royal Children's Hospital Melbourne
🇦🇺Parkville, Victoria, Australia
Kepler Universitätsklinikum Campus IV
🇦🇹Linz, Oberösterreich, Austria
Medizinische Universität Graz
🇦🇹Graz, Steiermark, Austria
Uniklinikum Salzburg - Landeskrankenhaus
🇦🇹Salzburg, Austria
Universitätsklinikum AKH Wien
🇦🇹Wien, Austria
Huderf / Ukzkf
🇧🇪Bruxelles - Brussel, Belgium
CU Saint-Luc/UZ St-Luc
🇧🇪Bruxelles - Brussel, Belgium
UZ Gent
🇧🇪Gent, Belgium
UZ Gasthuisberg - Pediatric Nephrology
🇧🇪Leuven, Belgium
CHC Montlégia - Pediatrics
🇧🇪Liège, Belgium
Santa Casa de Misericórdia de Belo Horizonte
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Hospital Pequeno Principe
🇧🇷Curitiba, Parana, Brazil
Hosp Clínicas Facult. Med. de Ribeirão Preto / USP
🇧🇷Ribeirão Preto/SP, Sao Paulo, Brazil
Hospital PUC-Campinas | Centro de Pesquisa Clínica Sao Lucas
🇧🇷São Paulo, Sao Paulo, Brazil
Hospital Infantil Sabará - Instituto PENSI - Pesquisa e Ensino em Saúde Infantil
🇧🇷Sao Paulo, SP, Brazil
Instituto da Crianca e do Adolescente
🇧🇷Sao Paulo, Brazil
Alberta Children's Hospital - Nephrology Clinic
🇨🇦Calgary, Alberta, Canada
The Hospital for Sick Children (SickKids)
🇨🇦Toronto, Ontario, Canada
CHU Sainte-Justine
🇨🇦Montreal, Quebec, Canada
Všeobecná fakultní nemocnice v Praze
🇨🇿Praha 2, Czechia
Fakultni nemocnice v Motole
🇨🇿Praha 5, Czechia
Rigshospitalet - Børn og Unge
🇩🇰Copenhagen, Denmark
Aarhus Universitetshospital - Børn og Unge
🇩🇰Århus N, Denmark
Odense Universitetshospital - HC Andersen Børne og Ungehospital
🇩🇰Odense C, Denmark
Helsinki University Hospital | Children's Hospital - Clinical Trial Unit, Nephrology Department
🇫🇮Helsinki, Finland
Tays Service Centre | Tampere University Hospital - Pediatric Early Phase Clinical Trials Unit
🇫🇮Tampere, Finland
Turun yliopistollinen keskussairaala
🇫🇮Turku, Finland
Hôpital des Enfants
🇫🇷TOULOUSE Cedex 9, France
CHU bordeaux - Hopital Pellegrin
🇫🇷BORDEAUX cedex, France
CHU de Lyon - Hopital Femme Mère Enfant
🇫🇷Bron, France
Hopital Arnaud de Villeneuve CHU Montpellier
🇫🇷Montpellier, France
CHU Strasbourg - Hopital Hautepierre
🇫🇷Strasbourg, France
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Baden-Württemberg, Germany
Medizinische Hochschule Hannover (MHH) | Zentrum Innere Medizin | Klinik fuer Kardiologie und Angiologie
🇩🇪Hannover, Niedersachsen, Germany
Kindernierenzentrum Bonn
🇩🇪Bonn, Nordrhein-Westfalen, Germany
Hopital Robert Debre
🇫🇷Paris, France
Universitätsklinikum Erlangen
🇩🇪Erlangen, Bayern, Germany
Universitätsklinikum Essen
🇩🇪Essen, Nordrhein-Westfalen, Germany
Universitaetsklinikum Muenster
🇩🇪Münster, Nordrhein-Westfalen, Germany
Charité / Pädiatrie
🇩🇪Berlin, Germany
Universitätsklinikum Hamburg Eppendorf (UKE)
🇩🇪Hamburg, Germany
Children's Hospital of Athens P&A Kyriakou - Pediatric Nephrology Department
🇬🇷Athens, Greece
Children's Hospital of Athens Agia Sofia - Pediatric Nephrology Department
🇬🇷Athens, Greece
University General Hospital of Heraklion - Department of Paediatrics
🇬🇷Heraklion, Greece
Univ. General Hospital of Ioannina - Department of Paediatrics, Nephrology Unit
🇬🇷Ioannina, Greece
Hippokration General Hospital of Thessaloniki - 3rd Department of Paediatrics, Nephrology Unit'
🇬🇷Thessaloniki, Greece
Semmelweis University
🇭🇺Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont
🇭🇺Debrecen, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
🇭🇺Pecs, Hungary
SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
🇭🇺Szeged, Hungary
All India Institute of Medical Sciences (AIIMS) - New Delhi
🇮🇳Delhi, India
NRS Medical college
🇮🇳Kolkata, India
Clalit Health | Soroka Medical Center - Internal Medicine Department
🇮🇱Beer Sheva, Israel
Wilf Children's Hospital Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Health Corporation of Galilee Medical Center
🇮🇱Nahariya, Israel
Clalit Health Services Schneider Children's Medical Center
🇮🇱Petach Tikva, Israel
Dana-Dwek Children's Hospital
🇮🇱Tel Aviv, Israel
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Pediatria
🇮🇹Bologna, Emilia-Romagna, Italy
Ospedale Pediatrico Bambino Gesù - Nefrologia
🇮🇹Roma, Lazio, Italy
IRCCS Istituto Giannina Gaslini - Nefrologia e Trapianto Rene
🇮🇹Genova, Liguria, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Nefrologia e Dialisi Pediatrica, Trapianti di Rene
🇮🇹Milano, Lombardia, Italy
Azienda Ospedaliera Universitaria Meyer IRCCS - Nefrologia e Dialisi
🇮🇹Firenze, Italy
Seoul National University Hospital
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Hospital of LT University of Health Sciences Kaunas Clinics
🇱🇹Kaunas, Lithuania
A.O.U. Città della Salute e della Scienza di Torino_Regina Margherita - Nefrologia Pediatrica
🇮🇹Torino, Italy
Kyungpook National University Hospital
🇰🇷Daegu, Daegu Gwang''yeogsi, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggido, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan-si, Gyeongsangnamdo, Korea, Republic of
Klaipeda Children's Hospital
🇱🇹Klaipeda, Lithuania
Vilnius University Hospital Santaros Klinikos Children's Hospital Paediatrics Centre
🇱🇹Vilnius, Lithuania
Universitair Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands
Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa
🇵🇱Bialystok, Poland
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
Uniwersytecki Szpital Dzieciecy w Krakowie
🇵🇱Krakow, Poland
Instytut Centrum Zdrowia Matki Polki
🇵🇱Lodz, Poland
Instytut "Pomnik - Centrum Zdrowia Dziecka"
🇵🇱Warszawa, Poland
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
🇵🇱Wroclaw, Poland
Hospital Santa Maria | Centro de Investigacao Clinica
🇵🇹Missing, Lisboa, Portugal
Centro Clinico Academico Braga | Braga, Portugal
🇵🇹Braga, Portugal
Hospital Pediátrico de Coimbra I ULS Coimbra
🇵🇹Coimbra, Portugal
Centro Hospitalar Universitario do Porto | Servico de Investigacao Clinica
🇵🇹Porto, Portugal
Ciutat Sanitaria i Universitaria de la Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital de Sant Joan de Déu
🇪🇸Barcelona, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital la Paz
🇪🇸Madrid, Spain
University Hospital of Malaga | Unidad de Gestion Clinica de Pediatria
🇪🇸Málaga, Spain
Virgen del Rocio University Hospital | Pediatric Nephrology Unit
🇪🇸Sevilla, Spain
Skåne University Hospital
🇸🇪Lund, Sweden
Karolinska University Hospital
🇸🇪Stockholm, Sweden
Uppsala University Hospital
🇸🇪Uppsala, Sweden
Universitäts-Kinderspital UKBB
🇨🇭Basel, Basel-Stadt, Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
🇨🇭Lausanne, Vaud, Switzerland
Hopital des Enfants HUG
🇨🇭Geneva, Switzerland
Hacettepe Universitesi Tip Fakultesi
🇹🇷Ankara, Turkey
Baskent Universitesi Tip Fakultesi Hastanesi
🇹🇷Ankara, Turkey
Gazi Universitesi Tip Fakultesi
🇹🇷Ankara, Turkey
Health Ministry Of Türkiye Republic Ankara Bilkent City Hospital
🇹🇷Ankara, Turkey
Istanbul Faculty of Medicine, Department of Internal Medicine, Department of Pediatrics
🇹🇷Istanbul, Turkey
Istanbul Universitesi Cerrahpasa - Cocuk Nefrolojisi
🇹🇷Istanbul, Turkey
Marmara University Medical Faculty | Pediatric Nephrology
🇹🇷Istanbul, Turkey
NHS Greater Glasgow and Clyde | Royal Hospital for Children - Glasgow Clinical Research Facility
🇬🇧Glasgow, Stratchclyde, United Kingdom
Birmingham Children's Hospital
🇬🇧Birmingham, West Midlands, United Kingdom
Queens Medical Centre
🇬🇧Nottingham, United Kingdom
Great Ormond Street Hospital for Children
🇬🇧London, United Kingdom
Royal Manchester Children's Hospital
🇬🇧Manchester, United Kingdom