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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
Sponsor: Bayer
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.
Official title: 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
Key Details
Gender
All
Age Range
6 Months - 17 Years
Study Type
INTERVENTIONAL
Enrollment
219
Start Date
2022-03-28
Completion Date
2027-05-10
Last Updated
2026-08-28
Healthy Volunteers
No
Conditions
Interventions
Finerenone (Kerendia, BAY94-8862)
Finerenone in different doses, treatment duration will be 180±7 days
Placebo
Placebo to finerenone, treatment duration will be 180±7 days
Locations (132)
Lucille Packard Children's Hospital Stanford - Pediatric Nephrology
Palo Alto, California, United States
UC San Diego - Altman Clinical and Translational Research Institute (ACTRI) - Linda Vista Clinic
San Diego, California, United States
Memorial Transplant Institute - Pediatric Nephrology
Hollywood, Florida, United States
The Charlotte R. Bloomberg Children's Center Building - Nephrology
Baltimore, Maryland, 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
OHSU Doernbecher Children's Hospital - Neurology
Portland, Oregon, United States
Eccles Primary Children's Outpatient Services - Nephrology
Salt Lake City, Utah, United States
Seattle Children's Hospital - Nephrology
Seattle, Washington, United States
Clinica de Nefrologia, Urologia y Enfermedades Cardiovascualares | Santa Fe, Argentina
Santa Fe, Santa Fe Province, Argentina
Instituto Universitario Hospital Italiano de Buenos Aires | Hospital Italiano de Buenos Aires - Neurology Department
Buenos Aires, Argentina
Hospital General de Ninos Pedro de Elizalde | Nephrology Department
Buenos Aires, Argentina
Hospital General de Ninos Ricardo Gutierrez | Pediatric Nephrology Department
Buenos Aires, Argentina
Centro de Rehabilitacion Cardiovascular | San Luis, Argentina
San Luis, Argentina
Queensland Children's Hospital
South Brisbane, Queensland, Australia
Monash Children's Hospital
Clayton, Victoria, Australia
Royal Children's Hospital Melbourne
Parkville, Victoria, Australia
Uniklinikum Salzburg - Landeskrankenhaus
Vienna, State of Vienna, Austria
Medizinische Univ Graz | Kinder & Jugendheilkunde
Graz, Styria, Austria
Kepler Universitätsklinikum Campus IV
Innsbruck, Tyrol, Austria
AKH Wien | Kinder & Jugendheilkunde, Kindernephrologie
Vienna, Vorarlberg, Austria
Huderf / Ukzkf
Brussels, Brussels Capital, Belgium
CU Saint-Luc/UZ St-Luc
Brussels, Brussels Capital, Belgium
UZ Gent
Ghent, East Flanders, Belgium
UZ Gasthuisberg - Pediatric Nephrology
Leuven, Flemish Brabant, Belgium
CHC Montlégia - Pediatrics
Liège, Belgium
Hospital Pequeno Principe
Curitiba, Paraná, Brazil
Hosp Clínicas Facult. Med. de Ribeirão Preto / USP
Ribeirão Preto, São Paulo, Brazil
Instituto da Crianca e do Adolescente
São Paulo, Brazil
Hospital PUC-Campinas | Centro de Pesquisa Clínica Sao Lucas
São Paulo, Brazil
Santa Casa de Misericórdia de Belo Horizonte
São Paulo, Brazil
UMHAT Sveti Georgi
Plovdiv, Plovdiv Province, Bulgaria
Alberta Children's Hospital | Nephrology Clinic
Calgary, Alberta, Canada
Centre hospitalier universitaire Sainte-Justine | Cardiology
Montreal, Quebec, Canada
Všeobecná fakultní nemocnice v Praze
Prague, Prague, Czechia
Fakultní nemocnice Motol a Homolka, Pracoviště MOTOL
Prague, Prague, Czechia
Rigshospitalet - Børn og Unge
Copenhagen, Capital Region / Region Hovedstaden, Denmark
Aarhus Universitetshospital - Børn og Unge
Aarhus N, Central Denmark Region / Region Midtjylland, Denmark
Odense Universitetshospital - HC Andersen Børne og Ungehospital
Odense, Region of Southern Denmark / Region Syddanmark, Denmark
Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS) - Lasten lääketutkimuskeskus PeeTU
Tampere, Pirkanmaa, Finland
Turun yliopistollinen keskussairaala
Turku, Southwest Finland, Finland
HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Uusi lastensairaala, nefrologia
Helsinki, Uusimaa, Finland
CHU bordeaux - Hopital Pellegrin
Bordeaux, New Aquitaine, France
CHU Toulouse - Hopital des enfants
Toulouse, Occitanie, France
CHU Lyon - Hopital Femme Mere Enfant - Service de nephrologie-rhumatologie-dermatologie pediatriques
Bron, France
CHU Montpellier - Hopital Arnaud de Villeneuve - Service nephrologie pediatrique
Montpellier, France
CHU Strasbourg - Hopital Hautepierre - Service nephrologie pediatrique
Strasbourg, France
APHP - Hopital Robert Debre
Paris, Île-de-France Region, France
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Medizinische Hochschule Hannover (MHH)
Hanover, Lower Saxony, Germany
Kindernierenzentrum Bonn
Bonn, North Rhine-Westphalia, Germany
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 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
Heraklion, Greece
University General Hospital Of Ioannina-Child Health Sector
Ioannina, Greece
Ippokratio General Hospital Of Thessaloniki-Pediatric Nephrology Unit, 3rd Department of Paediatrics
Thessaloniki, Greece
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, Baranya, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Csongrád-Csanád, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hajdú-Bihar, Hungary
Semmelweis University
Budapest, Hungary
Mavani Kidney Care
Ahmedabad, Gujarat, India
St. John's National Academy of Health Sciences
Bengaluru, Karnataka, India
All India Institute of Medical Sciences (AIIMS) - New Delhi
Delhi, National Capital Territory of Delhi, India
NRS Medical college
Kolkata, West Bengal, India
Clalit Health | Soroka Medical Center
Beersheba, 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
Petah Tikva, Israel
Dana-Dwek Children's Hospital
Tel Aviv, Israel
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Pediatria
Bologna, Italy
Azienda Ospedaliera Universitaria Meyer IRCCS - Nefrologia e Dialisi
Florence, Italy
IRCCS Istituto Giannina Gaslini - Nefrologia e Trapianto Rene
Genova, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Nefrologia e Dialisi Pediatrica, Trapianti di Rene
Milan, Italy
Ospedale Pediatrico Bambino Gesù - Nefrologia
Roma, Italy
A.O.U. Città della Salute e della Scienza di Torino_Regina Margherita - Nefrologia Pediatrica
Torino, Italy
Hospital of LT University of Health Sciences Kaunas Clinics
Kaunas, Kaunas County, Lithuania
Vilnius University Hospital Santaros Klinikos Children's Hospital Paediatrics Centre
Vilnius, Vilnius County, Lithuania
Hospital Universiti Sains Malaysia
Kelantan, Kelantan, Malaysia
Hospital Tunku Azizah
Wilayah Persekutuan Putrajaya, Kuala Lumpur, Malaysia
Hospital Tuanku Ja'afar
Seremban, Negeri Sembilan, Malaysia
Hospital Selayang
Shah Alam, Selangor, Malaysia
Sunway Medical Centre
Subang Jaya, Selangor, Malaysia
Sitio Alfredo Chew Wong | Aguascalientes, Mexico
Aguascalientes, Agguascalientes, Mexico
Instituto Nacional de Pediatría
México, D.F., Mexico City, Mexico
Instituto Veracruzano en Investigación Clinica SC
Veracruz, Mexico
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
Instytut Centrum Zdrowia Matki Polki
Lodz, Poland
Instytut "Pomnik - Centrum Zdrowia Dziecka"
Warsaw, Poland
Unidade Local de Saúde de Coimbra, E.P.E. - Hospital Pediátrico - Serviço de Pediatria Ambulatória - Nefrologia
Coimbra, Portugal
Unidade Local de Saúde de Santo António, E.P.E
Porto, Portugal
Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit
Soweto, Gauteng, South Africa
Seoul National University Bundang Hospital | Pediatric Nephrology
Seongnam-si, Gyeonggi-do, South Korea
Pusan National University Children's Hospital | Pediatric Nephrology
Yangsan, Gyeongsangnam-do, South Korea
Kyungpook National University Hospital | Pediatric Nephrology
Daegu, South Korea
Seoul National University Hospital | Pediatric Nephrology
Seoul, South Korea
Korea University Guro Hospital | Pediatric Nephrology
Seoul, South Korea
Hospital Sant Joan De Deu Barcelona | Nefrologia pediatrica
Esplugues de Llobregat, Barcelona, Spain
Hospital Universitari Vall D Hebron | Nefrologia pediatrica
Barcelona, Spain
Hospital Universitario 12 De Octubre | Nefrologia pediatrica
Madrid, Spain
Hospital Universitario La Paz | Nefrologia pediatrica
Madrid, Spain
Hospital Universitario Regional De Malaga | Nefrologia pediatrica
Málaga, Spain
Hospital Universitario Virgen Del Rocio S.L. | Nefrologia pediatrica
Seville, Spain
Skånes Universitetssjukhus - Lund - Barnnefroenheten
Lund, Skåne County, Sweden
Karolinska Universitetssjukhuset - Huddinge - Barnnjurmedicin
Stockholm - Huddinge, Sweden
Universitäts-Kinderspital UKBB
Basel, Canton of Basel-City, Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne University Hospital
Lausanne, Canton of Vaud, Switzerland
Hopital des Enfants HUG
Geneva, Switzerland
Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch
Guishan, Taoyuan, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital at Linkou
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Cukurova Univ. Tip. Fak. Balcali Hastanesi
Adana, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi
Ankara, Turkey (Türkiye)
Baskent Universitesi Tip Fakultesi Hastanesi
Ankara, Turkey (Türkiye)
Gazi Universitesi Tip Fakultesi
Ankara, Turkey (Türkiye)
T.C. Saglik Bakanligi Ankara Bilkent Sehir Hastanesi Noroloji ve Ortopedi Hastanesi Noroloji Bolumu
Ankara, Turkey (Türkiye)
Istanbul Faculty of Medicine, Department of Internal Medicine, Department of Pediatrics
Istanbul, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa - Cocuk Nefrolojisi
Istanbul, Turkey (Türkiye)
Marmara University Medical Faculty | Pediatric Nephrology
Istanbul, Turkey (Türkiye)
Great Ormond Street Hospital for Children | Clinical Research Facility
London, Greater London, United Kingdom
Royal Manchester Children's Hospital | Clinical Research Facility
Manchester, Greater Manchester, United Kingdom
Nottingham Children's Hospital | Renal and Urology Unit
Nottingham, Nottinghamshire, United Kingdom
Royal Hospital for Children | Glasgow Clinical Research Facility
Glasgow, Scotland, United Kingdom