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

Status: Recruiting
Location: See all (167) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arizona
Phoenix Children's Hospital | Main - Transplant Department
WITHDRAWN
Phoenix
California
Cedars-Sinai Samuel Oschin Cancer Center
WITHDRAWN
Los Angeles
Lucille Packard Children's Hospital Stanford - Pediatric Nephrology
NOT_YET_RECRUITING
Palo Alto
Rady Children's Hospital San Diego - Cardiology
NOT_YET_RECRUITING
San Diego
Washington, D.c.
Children's National Medical Center - Nephrology
NOT_YET_RECRUITING
Washington D.c.
Florida
Memorial Transplant Institute - Pediatric Nephrology
NOT_YET_RECRUITING
Hollywood
Georgia
Emory University Hospital/Children's Healthcare of Atlanta - Nephrology
WITHDRAWN
Atlanta
Iowa
University of Iowa Health Care Medical Center - Nephrology
NOT_YET_RECRUITING
Iowa City
Massachusetts
Boston Children's Hospital - Main Campus - Nephrology
WITHDRAWN
Boston
Maryland
The Charlotte R. Bloomberg Children's Center Building - Nephrology
NOT_YET_RECRUITING
Baltimore
Missouri
Children's Mercy Hospital Kansas City - Nephrology
NOT_YET_RECRUITING
Kansas City
Ohio
Cincinnati Children's Hospital Medical Center | Division of Nephrology and Hypertension
NOT_YET_RECRUITING
Cincinnati
Cleveland Clinic | Pediatric Nephrology
RECRUITING
Cleveland
Oregon
OHSU Doernbecher Children's Hospital - Neurology
NOT_YET_RECRUITING
Portland
Pennsylvania
Children's Hospital of Philadelphia - Nephrology
NOT_YET_RECRUITING
Philadelphia
Texas
University Hospital - San Antonio - Pediatric Nephrology
WITHDRAWN
San Antonio
Utah
Primary Children's Hospital
NOT_YET_RECRUITING
Salt Lake City
Washington
Seattle Children's Hospital - Nephrology
NOT_YET_RECRUITING
Seattle
Other Locations
Argentina
Hospital de Pediatría Juan P. Garrahan
NOT_YET_RECRUITING
Buenos Aires
Hospital Italiano de Buenos Aires
RECRUITING
Buenos Aires
Hospital General de Ninos Pedro de Elizalde | Nephrology Department
NOT_YET_RECRUITING
Ciudad Autonoma De Buenos Aire
Hospital General de Ninos Ricardo Gutierrez | Pediatric Nephrology Department
RECRUITING
Ciudad Autonoma De Buenos Aire
Hospital de Niños Sor María Ludovica
WITHDRAWN
La Plata
Many Locations
NOT_YET_RECRUITING
Multiple Locations
Centro de Rehabilitacion Cardiovascular | San Luis, Argentina
RECRUITING
San Luis
Clinica de Nefrologia, Urologia y Enfermedades Cardiovascualares | Santa Fe, Argentina
NOT_YET_RECRUITING
Santa Fe
Australia
Monash Children's Hospital
WITHDRAWN
Clayton
Royal Children's Hospital Melbourne
RECRUITING
Parkville
Queensland Children's Hospital
RECRUITING
South Brisbane
Austria
Medizinische Universität Graz
NOT_YET_RECRUITING
Graz
Kepler Universitätsklinikum Campus IV
RECRUITING
Linz
Many Locations
RECRUITING
Multiple Locations
Uniklinikum Salzburg - Landeskrankenhaus
NOT_YET_RECRUITING
Salzburg
Universitätsklinikum AKH Wien
NOT_YET_RECRUITING
Vienna
Belgium
CU Saint-Luc/UZ St-Luc
NOT_YET_RECRUITING
Bruxelles - Brussel
Huderf / Ukzkf
NOT_YET_RECRUITING
Bruxelles - Brussel
UZ Gent
RECRUITING
Ghent
UZ Gasthuisberg - Pediatric Nephrology
RECRUITING
Leuven
CHC Montlégia - Pediatrics
NOT_YET_RECRUITING
Liège
Many Locations
RECRUITING
Multiple Locations
Brazil
Santa Casa de Misericórdia de Belo Horizonte
NOT_YET_RECRUITING
Belo Horizonte
Hospital Pequeno Principe
NOT_YET_RECRUITING
Curitiba
Hosp Clínicas Facult. Med. de Ribeirão Preto / USP
NOT_YET_RECRUITING
Ribeirão Preto/sp
Hospital Infantil Sabará - Instituto PENSI - Pesquisa e Ensino em Saúde Infantil
NOT_YET_RECRUITING
São Paulo
Hospital PUC-Campinas | Centro de Pesquisa Clínica Sao Lucas
NOT_YET_RECRUITING
São Paulo
Instituto da Crianca e do Adolescente
NOT_YET_RECRUITING
São Paulo
Bulgaria
UMHAT Sveti Georgi
NOT_YET_RECRUITING
Plovdiv
SHATPD Prof. Ivan Mitev
NOT_YET_RECRUITING
Sofia
MHAT prof. Stoyan Kirkovitch AD
NOT_YET_RECRUITING
Stara Zagora
Canada
Alberta Children's Hospital - Nephrology Clinic
NOT_YET_RECRUITING
Calgary
CHU Sainte-Justine
RECRUITING
Montreal
The Hospital for Sick Children (SickKids)
NOT_YET_RECRUITING
Toronto
Denmark
Aarhus Universitetshospital - Børn og Unge
RECRUITING
Århus N
Rigshospitalet - Børn og Unge
NOT_YET_RECRUITING
Copenhagen
Many Locations
RECRUITING
Multiple Locations
Odense Universitetshospital - HC Andersen Børne og Ungehospital
RECRUITING
Odense C
Finland
Helsinki University Hospital | Children's Hospital - Clinical Trial Unit, Nephrology Department
RECRUITING
Helsinki
Many Locations
RECRUITING
Multiple Locations
Tays Service Centre | Tampere University Hospital - Pediatric Early Phase Clinical Trials Unit
RECRUITING
Tampere
Turun yliopistollinen keskussairaala
NOT_YET_RECRUITING
Turku
France
CHU bordeaux - Hopital Pellegrin
NOT_YET_RECRUITING
Bordeaux
CHU de Lyon - Hopital Femme Mère Enfant
RECRUITING
Bron
Hopital Arnaud de Villeneuve CHU Montpellier
NOT_YET_RECRUITING
Montpellier
Many Locations
RECRUITING
Multiple Locations
Hopital Robert Debre
RECRUITING
Paris
CHU Strasbourg - Hopital Hautepierre
NOT_YET_RECRUITING
Strasbourg
Hôpital des Enfants
RECRUITING
Toulouse
Germany
Charité / Pädiatrie
RECRUITING
Berlin
Kindernierenzentrum Bonn
WITHDRAWN
Bonn
Kindernierenzentrum Bonn
NOT_YET_RECRUITING
Bonn
Universitätsklinikum Erlangen
WITHDRAWN
Erlangen
Universitätsklinikum Essen
RECRUITING
Essen
Universitätsklinikum Hamburg Eppendorf (UKE)
SUSPENDED
Hamburg
Medizinische Hochschule Hannover (MHH) | Zentrum Innere Medizin | Klinik fuer Kardiologie und Angiologie
NOT_YET_RECRUITING
Hanover
Universitätsklinikum Heidelberg
NOT_YET_RECRUITING
Heidelberg
Many Locations
RECRUITING
Multiple Locations
Universitätsklinikum Münster
NOT_YET_RECRUITING
Münster
Greece
Children's Hospital of Athens Agia Sofia - Pediatric Nephrology Department
RECRUITING
Athens
Children's Hospital of Athens P&A Kyriakou - Pediatric Nephrology Department
RECRUITING
Athens
University General Hospital of Heraklion - Department of Paediatrics
RECRUITING
Heraklion
Univ. General Hospital of Ioannina - Department of Paediatrics, Nephrology Unit
RECRUITING
Ioannina
Many Locations
RECRUITING
Multiple Locations
Ippokratio General Hospital Of Thessaloniki-Pediatric Nephrology Unit, 3rd Department of Paediatrics
NOT_YET_RECRUITING
Thessaloniki
Hungary
Semmelweis University
NOT_YET_RECRUITING
Budapest
Debreceni Egyetem Klinikai Kozpont
RECRUITING
Debrecen
Many Locations
RECRUITING
Multiple Locations
Pecsi Tudomanyegyetem Klinikai Kozpont
RECRUITING
Pécs
SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
NOT_YET_RECRUITING
Szeged
India
All India Institute of Medical Sciences (AIIMS) - New Delhi
NOT_YET_RECRUITING
Delhi
NRS Medical college
NOT_YET_RECRUITING
Kolkata
Israel
Clalit Health | Soroka Medical Center - Internal Medicine Department
RECRUITING
Beersheba
Wilf Children's Hospital Shaare Zedek Medical Center
NOT_YET_RECRUITING
Jerusalem
Many Locations
RECRUITING
Multiple Locations
Health Corporation of Galilee Medical Center
RECRUITING
Nahariya
Clalit Health Services Schneider Children's Medical Center
RECRUITING
Petah Tikva
Dana-Dwek Children's Hospital
RECRUITING
Tel Aviv
Italy
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Pediatria
RECRUITING
Bologna
Azienda Ospedaliera Universitaria Meyer IRCCS - Nefrologia e Dialisi
NOT_YET_RECRUITING
Florence
IRCCS Istituto Giannina Gaslini - Nefrologia e Trapianto Rene
RECRUITING
Genoa
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Nefrologia e Dialisi Pediatrica, Trapianti di Rene
RECRUITING
Milan
Many Locations
RECRUITING
Multiple Locations
Ospedale Pediatrico Bambino Gesù - Nefrologia
RECRUITING
Rome
A.O.U. Città della Salute e della Scienza di Torino_Regina Margherita - Nefrologia Pediatrica
NOT_YET_RECRUITING
Torino
Lithuania
Hospital of LT University of Health Sciences Kaunas Clinics
RECRUITING
Kaunas
Klaipeda Children's Hospital
NOT_YET_RECRUITING
Klaipėda
Many Locations
RECRUITING
Multiple Locations
Vilnius University Hospital Santaros Klinikos Children's Hospital Paediatrics Centre
RECRUITING
Vilnius
Malaysia
Hospital Universiti Sains Malaysia
NOT_YET_RECRUITING
Kelantan
Hospital Tuanku Ja'afar
NOT_YET_RECRUITING
Seremban
Hospital Selayang
NOT_YET_RECRUITING
Shah Alam
Sunway Medical Centre
NOT_YET_RECRUITING
Subang Jaya
Hospital Tunku Azizah
NOT_YET_RECRUITING
Wilayah Persekutuan
Mexico
Sitio Alfredo Chew Wong | Aguascalientes, Mexico
NOT_YET_RECRUITING
Aguascalientes
Hospital Infantil de México Dr. Federico Gómez
NOT_YET_RECRUITING
México D.f.
Instituto Nacional de Pediatría
NOT_YET_RECRUITING
México, D.f.
Hospital Universitario José Eleuterio González
NOT_YET_RECRUITING
Monterrey
Instituto Veracruzano en Investigación Clinica SC
NOT_YET_RECRUITING
Veracruz
Netherlands
Universitair Medisch Centrum Groningen
RECRUITING
Groningen
Many Locations
NOT_YET_RECRUITING
Multiple Locations
University Medical Center Utrecht
RECRUITING
Utrecht
Poland
Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa
RECRUITING
Bialystok
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
Uniwersytecki Szpital Dzieciecy w Krakowie
WITHDRAWN
Krakow
Instytut Centrum Zdrowia Matki Polki
RECRUITING
Lodz
Many Locations
RECRUITING
Multiple Locations
Instytut Pomnik - Centrum Zdrowia Dziecka
RECRUITING
Warsaw
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
WITHDRAWN
Wroclaw
Portugal
Centro Clinico Academico Braga | Braga, Portugal
WITHDRAWN
Braga
Hospital Pediátrico de Coimbra I ULS Coimbra
NOT_YET_RECRUITING
Coimbra
Hospital Santa Maria | Centro de Investigacao Clinica
NOT_YET_RECRUITING
Missing
Centro Hospitalar Universitario do Porto | Servico de Investigacao Clinica
RECRUITING
Porto
Republic of Korea
Kyungpook National University Hospital
RECRUITING
Daegu
Many Locations
RECRUITING
Multiple Locations
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Korea University Guro Hospital
NOT_YET_RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Pusan National University Yangsan Hospital
RECRUITING
Yangsan
Spain
Ciutat Sanitaria i Universitaria de la Vall d'Hebron
RECRUITING
Barcelona
Hospital de Sant Joan de Déu
RECRUITING
Barcelona
Hospital la Paz
NOT_YET_RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Regional De Malaga - Nefrologia pediatrica
RECRUITING
Málaga
Many Locations
RECRUITING
Multiple Locations
Hospital Universitario Virgen Del Rocio S.L. - Nefrologia pediatrica
RECRUITING
Seville
Sweden
Skåne University Hospital
NOT_YET_RECRUITING
Lund
Many Locations
NOT_YET_RECRUITING
Multiple Locations
Karolinska University Hospital
NOT_YET_RECRUITING
Stockholm
Uppsala University Hospital
WITHDRAWN
Uppsala
Switzerland
Universitäts-Kinderspital UKBB
RECRUITING
Basel
Hopital des Enfants HUG
RECRUITING
Geneva
Centre Hospitalier Universitaire Vaudois (CHUV)
RECRUITING
Lausanne
Many Locations
RECRUITING
Multiple Locations
Turkey
Cukurova Univ. Tip. Fak. Balcali Hastanesi
NOT_YET_RECRUITING
Adana
Baskent Universitesi Tip Fakultesi Hastanesi
RECRUITING
Ankara
Gazi Universitesi Tip Fakultesi
NOT_YET_RECRUITING
Ankara
Hacettepe Universitesi Tip Fakultesi
NOT_YET_RECRUITING
Ankara
Health Ministry Of Türkiye Republic Ankara Bilkent City Hospital
RECRUITING
Ankara
Istanbul Faculty of Medicine, Department of Internal Medicine, Department of Pediatrics
NOT_YET_RECRUITING
Istanbul
Istanbul Universitesi Cerrahpasa - Cocuk Nefrolojisi
RECRUITING
Istanbul
Marmara University Medical Faculty | Pediatric Nephrology
RECRUITING
Istanbul
Many Locations
RECRUITING
Multiple Locations
United Kingdom
Birmingham Children's Hospital
NOT_YET_RECRUITING
Birmingham
NHS Greater Glasgow and Clyde | Royal Hospital for Children - Glasgow Clinical Research Facility
RECRUITING
Glasgow
Great Ormond Street Hospital for Children NHS Foundation Trust | Great Ormond Street Hospital - Clinical Research Facility
RECRUITING
London
Manchester University NHS Foundation Trust | Royal Manchester Children's Hospital - Clinical Research Facility
RECRUITING
Manchester
Many Locations
RECRUITING
Multiple Locations
Nottingham University Hospitals NHS Trust | Queens Medical Centre - Childrens Clinical Research Facility
NOT_YET_RECRUITING
Nottingham
Contact Information
Primary
Bayer Clinical Trials Contact
clinical-trials-contact@bayer.com
(+)1-888-84 22937
Time Frame
Start Date: 2022-11-08
Estimated Completion Date: 2029-02-27
Participants
Target number of participants: 100
Treatments
Experimental: Finerenone Open-Label safety Extension
Participants will receive finerenone treatment.
Related Therapeutic Areas
Sponsors
Leads: Bayer

This content was sourced from clinicaltrials.gov