N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Bayer • ClinicalTrials.gov ID: NCT05457283

Registry updated: 2026-09-24
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

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.

Interventions

  • Finerenone (Kerendia, BAY94-8862) (Drug)
    Finerenone in different doses, treatment duration will be 540 ±7 days.

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Conditions

Chronic Kidney Disease Proteinuria Children

Locations

  • Phoenix Children's Hospital | Main - Transplant Department — Phoenix, Arizona, United States
  • Cedars-Sinai Samuel Oschin Cancer Center — Los Angeles, California, United States
  • Lucille Packard Children's Hospital Stanford - Pediatric Nephrology — Palo Alto, California, United States
  • Rady Children's Hospital San Diego - Cardiology — San Diego, California, United States
  • Children's National Hospital - Nephrology — Washington D.C., District of Columbia, United States
  • Memorial Transplant Institute - Pediatric Nephrology — Hollywood, Florida, United States
  • Emory University Hospital/Children's Healthcare of Atlanta - Nephrology — Atlanta, Georgia, United States
  • University of Iowa Health Care Medical Center - Nephrology — 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
  • OHSU Doernbecher Children's Hospital - Neurology — Portland, Oregon, United States
  • Children's Hospital of Philadelphia - Nephrology — Philadelphia, Pennsylvania, United States
  • University Hospital - San Antonio - Pediatric Nephrology — San Antonio, Texas, 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
  • 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 — 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
  • Universitätsklinikum AKH Wien — Vienna, State of Vienna, Austria
  • Medizinische Universität Graz, Landeskrankenhaus-Universitätsklinikum Graz — Graz, Styria, Austria
  • Kepler Universitätsklinikum Campus IV — Innsbruck, Tyrol, 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
  • Hospital Infantil Sabará - Instituto PENSI - Pesquisa e Ensino em Saúde Infantil — 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
  • SHATPD "Prof. Ivan Mitev" — Sofia, Sofia City Province, Bulgaria
  • MHAT prof. Stoyan Kirkovitch AD — Stara Zagora, Stara Zagora 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) | Zentrum Innere Medizin | Klinik fuer Kardiologie und Angiologie — 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
  • Hospital Infantil de México "Dr. Federico Gómez" — México D.F., Mexico City, Mexico
  • Instituto Nacional de Pediatría — México, D.F., Mexico City, Mexico
  • Hospital Universitario "José Eleuterio González" — Monterrey, Nuevo León, 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
  • Uniwersytecki Szpital Dzieciecy w Krakowie — Krakow, Poland
  • Instytut Centrum Zdrowia Matki Polki — Lodz, Poland
  • Instytut "Pomnik - Centrum Zdrowia Dziecka" — Warsaw, Poland
  • Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu — Wroclaw, Poland
  • Unidade Local de Saúde de Braga E.P.E. - Centro Clínico Académico de Braga - Serviço de Pediatria — Braga, Portugal
  • 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
  • OBSOLETE_Uppsala University Hospital — Uppsala, Uppsala 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
  • Kaohsiung Veterans General Hospital — Kaohsiung City, 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
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record