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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified March 2026 by Bayer
Sponsor
Bayer
Information Provided by (Responsible Party)
Bayer
Clinicaltrials.gov Identifier
NCT05196035
Other Study ID Numbers:
19920
First Submitted
January 6, 2022
First Posted
January 18, 2022
Last Update Posted
April 16, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Chronic Kidney DiseaseProteinuria
Drug: Finerenone (Kerendia, BAY94-8862)Drug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment219 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA 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
Study Start DateMarch 27, 2022
Actual Primary Completion Date1yr 3mos from now
Actual Study Completion Date1yr 4mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Finerenone (Kerendia, BAY94-8862)
Participants will receive finerenone treatment.
Drug: Finerenone (Kerendia, BAY94-8862)
Finerenone in different doses, treatment duration will be 180&plusmn;7 days
Placebo
Participants will receive placebo to finerenone.
Drug: Placebo
Placebo to finerenone, treatment duration will be 180&plusmn;7 days

Outcome Measures

Primary Outcome Measures
  1. Percent change in Urinary protein-to-creatinine ratio (UPCR) reduction from baseline to day 180+/-7
    Percent change from baseline to day 180&plusmn;7 in UPCR will be calculated.
Secondary Outcome Measures
  1. Number participants with treatment emergent adverse events (TEAEs)
    Below sub-categories will be considered: 1. Serious Treatment Emergent Adverse Events (TEAEs) 2. TEAEs and serious TEAEs leading to discontinuation of treatment 3. Study drug related TEAEs and serious TEAEs 4. TEAEs categorized by severity (mild, moderate, severe) 5. TEAEs by maximum intensity 6. Number of participants hospitalized with hyperkalemia, 7. Number of participants discontinuing due to hyperkalemia, 8. Number of participants with hospitalization for worsening of renal function 9. Number of participants discontinuing due to worsening of renal function
  2. Change in serum potassium levels from baseline to day 180±7
  3. Change in serum creatinine from baseline to day 180±7
  4. Change in eGFR from baseline to day 180±7
    Estimated glomerular filtration rate (eGFR)
  5. Change in systolic blood pressure from baseline to day 180±7
  6. UPCR reduction of at least 30% from baseline to day 180+/-7
    Proportion of participants at day 180+/-7 with a \&gt;=30% reduction in PUCR compared to baseline
  7. Change in UACR from baseline to day 180±7
    Urinary albumin-to-creatinine ratio (UACR)
  8. Pharmacokinetics (PK) finerenone Cmax, md
    Maximum observed finerenone concentration in plasma after multiple doses.
  9. Pharmacokinetics (PK) finerenone AUCτ,md
    Area under the curve for finerenone concentration in plasma after multiple doses.
  10. Taste and texture questionnaire of the pediatric formulation

Eligibility Criteria

Ages Eligible for Study(Child)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Participants must be 6 months to \<18 years old at the time when the informed consent/assent is signed
Participants must have a clinical diagnosis of chronic kidney disease (CKD) at screening which is defined as
CKD stages 1-3 (eGFR ≥30 mL/min/1.73m\^2) for children ≥1 year to \<18 years of age or
a serum creatinine ≤ 0.40 mg/dL for infants 6 months to \< 1 year of age and
severely increased proteinuria as defined by
Urinary protein-to-creatinine ratio (UPCR) of ≥ 0.50 g/g in participants ≥ 2 years with CKD stage 2 and 3 or
UPCR ≥ 1.0 g/g for patients \< 2 years of age or ≥ 2 years of age and with CKD stage 1
Participants must have stable kidney function between screening and D0 defined as:
For participants with a creatinine of \> 0.8 mg/dL at screening: no increase or decrease in eGFR by ≥ 20% at D0
For participants with a creatinine of ≤ 0.8 mg/dL at screening: no increase or decrease in creatinine ≥ 0.15 mg/dL at D0.
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 management, unchanged for at least 30 days prior to screening
K+ ≤5.0 mmol/L for children ≥2 years of age at both screening and D0, and ≤5.3 mmol/L for children \<2 years of age at both screening and D0
Exclusion Criteria
Planned urological surgery expected to influence renal function
Children with hemolytic uremic syndrome (HUS) diagnosed ≤6 months prior to screening
Patients with nephrotic syndrome receiving albumin infusions within the last 6 months prior to screening
Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame
Renal allograft in place
Bilateral renal artery stenosis
Acute kidney injury requiring dialysis within 6 months prior to screening
Systemic hypertension stage 2 in children ≥1 year of age defined according to guidelines on blood pressure management at screening or randomization
Systolic blood pressure (SBP) above 110 mmHg in infants 6 months to \<1 year of age at screening or randomization
Systemic hypotension defined as a systolic blood pressure below the 5th percentile for age, sex and height at either screening or randomization but no lower than 80 mmHg (although for some participants the 5th percentile of SBP is \< 80 mmHg they must be excluded if their SBP is \<80 mmHg)
Participants with immune-mediated CKD using rituximab, cyclophosphamide, abatacept, or high-dose glucocorticoids, within \<6 months prior to screening

Contacts and Locations

Sponsors and CollaboratorsBayer
Locations
Phoenix Children's Hospital | Main - Transplant Department | Phoenix Arizona, United States, 85016Cedars-Sinai Medical Center - Nephrology | Los Angeles California, United States, 90048Lucille Packard Children's Hospital Stanford - Pediatric Nephrology | Palo Alto California, United States, 94304UC San Diego - Altman Clinical and Translational Research Institute (ACTRI) - Linda Vista Clinic | San Diego California, United States, 92023Children's National Hospital - Nephrology | Washington D.C. District of Columbia, United States, 20010Memorial Transplant Institute - Pediatric Nephrology | Hollywood Florida, United States, 33021Emory University Hospital/Children's Healthcare of Atlanta - Nephrology | Atlanta Georgia, United States, 30322University of Iowa Health Care Medical Center - Nephrology | Iowa City Iowa, United States, 52242The Charlotte R. Bloomberg Children's Center Building - Nephrology | Baltimore Maryland, United States, 21287Boston Children's Hospital - Main Campus - Nephrology | Boston Massachusetts, United States, 02115Children's Mercy Hospital Kansas City - Nephrology | Kansas City Missouri, United States, 64108Cincinnati Children's Hospital Medical Center | Division of Nephrology and Hypertension | Cincinnati Ohio, United States, 45229Cleveland Clinic | Pediatric Nephrology | Cleveland Ohio, United States, 14013Nationwide Children's Hospital - Nephrology | Columbus Ohio, United States, 43205OHSU Doernbecher Children's Hospital - Neurology | Portland Oregon, United States, 97239Children's Hospital of Philadelphia - Nephrology | Philadelphia Pennsylvania, United States, 19104Univ of Texas Health Science Center | Nephrology Res Dept | San Antonio Texas, United States, 78207Eccles Primary Children's Outpatient Services - Nephrology | Salt Lake City Utah, United States, 84113Seattle Children's Hospital - Nephrology | Seattle Washington, United States, 98105Instituto Universitario Hospital Italiano de Buenos Aires | Hospital Italiano de Buenos Aires - Neurology Department | Ciudad Autonoma de Buenos Aire Ciudad Auton. de Buenos Aires, Argentina, C1199ABBHospital General de Ninos Ricardo Gutierrez | Pediatric Nephrology Department | Ciudad Autonoma de Buenos Aire Ciudad Auton. de Buenos Aires, Argentina, C1425EFDCentro de Rehabilitacion Cardiovascular | San Luis, Argentina | San Luis San Luis Province, Argentina, D5700CGRClinica de Nefrologia, Urologia y Enfermedades Cardiovascualares | Santa Fe, Argentina | Santa Fe Santa Fe Province, Argentina, S3000Hospital de Pediatría Juan P. Garrahan | Buenos Aires , Argentina, C1249ABNHospital General de Ninos Pedro de Elizalde | Nephrology Department | Buenos Aires , Argentina, C1270The Children's Hospital at Westmead | Westmead New South Wales, Australia, 2145Queensland Children's Hospital | South Brisbane Queensland, Australia, 4101Monash Children's Hospital | Clayton Victoria, Australia, 3168Royal Children's Hospital Melbourne | Parkville Victoria, Australia, 3052Uniklinikum Salzburg - Landeskrankenhaus | Vienna State of Vienna, Austria, 1090Medizinische Univ Graz | Kinder & Jugendheilkunde | Graz Styria, Austria, 8036Kepler Universitätsklinikum Campus IV | Innsbruck Tyrol, Austria, 6020AKH Wien | Kinder & Jugendheilkunde, Kindernephrologie | Vienna Vorarlberg, Austria, 6800Huderf / Ukzkf | Bruxelles - Brussel , Belgium, 1020CU Saint-Luc/UZ St-Luc | Bruxelles - Brussel , Belgium, 1200UZ Gent | Ghent , Belgium, 9000UZ Gasthuisberg - Pediatric Nephrology | Leuven , Belgium, 3000CHC Montlégia - Pediatrics | Liège , Belgium, 4000Hospital Pequeno Principe | Curitiba Paraná, Brazil, 80250-060Hosp Clínicas Facult. Med. de Ribeirão Preto / USP | Ribeirão Preto São Paulo, Brazil, 14051-140Hospital Infantil Sabará - Instituto PENSI - Pesquisa e Ensino em Saúde Infantil | São Paulo São Paulo, Brazil, 01227-200Instituto da Crianca e do Adolescente | São Paulo São Paulo, Brazil, 05403 000Hospital PUC-Campinas | Centro de Pesquisa Clínica Sao Lucas | São Paulo São Paulo, Brazil, 13034-685Santa Casa de Misericórdia de Belo Horizonte | São Paulo São Paulo, Brazil, 30150-221UMHAT Sveti Georgi | Plovdiv Plovdiv Province, Bulgaria, 4002SHATPD "Prof. Ivan Mitev" | Sofia Sofia City Province, Bulgaria, 1606MHAT prof. Stoyan Kirkovitch AD | Stara Zagora Stara Zagora Province, Bulgaria, 6003Alberta Children's Hospital | Nephrology Clinic | Calgary Alberta, Canada, T3B 6A8McMaster University Medical Centre | McMaster Children's Hospital | Cardiology | Hamilton Ontario, Canada, L8N 3Z5The Hospital for Sick Children (SickKids) | Toronto Ontario, Canada, M5G 1X8Centre hospitalier universitaire Sainte-Justine | Cardiology | Montreal Quebec, Canada, H3T 1C5Všeobecná fakultní nemocnice v Praze | Prague , Czechia, 128 08Fakultní nemocnice Motol a Homolka, Pracovište MOTOL | Prague , Czechia, 150 06Rigshospitalet - Børn og Unge | Copenhagen Capital Region, Denmark, 2100Aarhus Universitetshospital - Børn og Unge | Aarhus N Central Jutland, Denmark, 8200Odense Universitetshospital - HC Andersen Børne og Ungehospital | Odense Region Syddanmark, Denmark, 5000Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS) - Lasten lääketutkimuskeskus PeeTU | Tampere Pirkanmaa, Finland, 33521Turun yliopistollinen keskussairaala | Turku Southwest Finland, Finland, 20520HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Uusi lastensairaala, nefrologia | Helsinki Uusimaa, Finland, 00290CHU de Lyon - Hopital Femme Mère Enfant | Bron Auvergne-Rhône-Alpes, France, 69677CHU Strasbourg - Hopital Hautepierre | Strasbourg Grand Est, France, 67200CHU bordeaux - Hopital Pellegrin | Bordeaux New Aquitaine, France, 33076Hopital Arnaud de Villeneuve CHU Montpellier | Montpellier Occitanie, France, 34059Hôpital des Enfants | Toulouse Occitanie, France, 31059Hopital Robert Debre | Paris Île-de-France Region, France, 75019Universitätsklinikum Heidelberg | Heidelberg Baden-Wurttemberg, Germany, 69115Universitätsklinikum Erlangen | Erlangen Bavaria, Germany, 91054Medizinische Hochschule Hannover (MHH) | Hanover Lower Saxony, Germany, 30625Kindernierenzentrum Bonn | Bonn North Rhine-Westphalia, Germany, 53127Universitätsklinikum Essen | Essen North Rhine-Westphalia, Germany, 45147Universitätsklinikum Münster | Münster North Rhine-Westphalia, Germany, 48149Charité / Pädiatrie | Berlin , Germany, 13353Universitätsklinikum Hamburg Eppendorf (UKE) | Hamburg , Germany, 20246Children's Hospital of Athens P&A Kyriakou - Pediatric Nephrology Department | Athens , Greece, 11526Children's Hospital of Athens Agia Sofia - Pediatric Nephrology Department | Athens , Greece, 11527University General Hospital of Heraklion | Heraklion , Greece, 71110University General Hospital Of Ioannina-Child Health Sector | Ioannina , Greece, 45500Ippokratio General Hospital Of Thessaloniki-Pediatric Nephrology Unit, 3rd Department of Paediatrics | Thessaloniki , Greece, 54642Semmelweis University | Budapest , Hungary, 1083Debreceni Egyetem Klinikai Kozpont | Debrecen , Hungary, 4032Pecsi Tudomanyegyetem Klinikai Kozpont | Pécs , Hungary, 7623Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ | Szeged , Hungary, 6720Institute of Kidney Diseases and Research Center Gujarat University of Transplantation Sciences | Ahmedabad Gujarat, India, 380016Mavani Kidney Care | Ahmedabad Gujarat, India, 380052St. John's National Academy of Health Sciences | Bengaluru Karnataka, India, 560034All India Institute of Medical Sciences (AIIMS) - New Delhi | Delhi National Capital Territory of Delhi, India, 110029NRS Medical college | Kolkata West Bengal, India, 700014Post Graduate Institute of Medical Education and Research | Chandigarh , India, 160012Clalit Health | Soroka Medical Center - Internal Medicine Department | Beersheba , Israel, 8410101Wilf Children's Hospital Shaare Zedek Medical Center | Jerusalem , Israel, 9103102Health Corporation of Galilee Medical Center | Nahariya , Israel, 2210001Clalit Health Services Schneider Children's Medical Center | Petah Tikva , Israel, 4920235Dana-Dwek Children's Hospital | Tel Aviv , Israel, 6423906Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Pediatria | Bologna Emilia-Romagna, Italy, 40138Ospedale Pediatrico Bambino Gesù - Nefrologia | Rome Lazio, Italy, 00165IRCCS Istituto Giannina Gaslini - Nefrologia e Trapianto Rene | Genoa Liguria, Italy, 16147Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Nefrologia e Dialisi Pediatrica, Trapianti di Rene | Milan Lombardy, Italy, 20122Azienda Ospedaliera Universitaria Meyer IRCCS - Nefrologia e Dialisi | Florence , Italy, 50139A.O.U. Città della Salute e della Scienza di Torino_Regina Margherita - Nefrologia Pediatrica | Torino , Italy, 10126Hospital of LT University of Health Sciences Kaunas Clinics | Kaunas , Lithuania, LT-50161Klaipeda Children's Hospital | Klaipėda , Lithuania, LT-92140Vilnius University Hospital Santaros Klinikos Children's Hospital Paediatrics Centre | Vilnius , Lithuania, LT-08406Hospital Universiti Sains Malaysia | Kelantan Kelantan, Malaysia, 16150Hospital Tunku Azizah | Wilayah Persekutuan Putrajaya Kuala Lumpur, Malaysia, 50300Hospital Tuanku Ja'afar | Seremban Negeri Sembilan, Malaysia, 70300Hospital Selayang | Shah Alam Selangor, Malaysia, 68100Sunway Medical Centre | Subang Jaya Selangor, Malaysia, 47500Sitio Alfredo Chew Wong | Aguascalientes, Mexico | Aguascalientes Agguascalientes, Mexico, 20124Instituto Veracruzano en Investigación Clinica SC | Mexico City Mexico City, Mexico, 11850Hospital Infantil de México "Dr. Federico Gómez" | México D.F. Mexico City, Mexico, 6720Instituto Nacional de Pediatría | México, D.F. Mexico City, Mexico, 4530Hospital Universitrio Dr. José Eleuterio González. Servicio de Oncologia | Nuevo León Monterrey, Mexico, 64460Hospital Regional de Alta Especialidad Ixtapaluca | Ixtapaluca State of Mexico, Mexico, 56530.Universitair Medisch Centrum St. Radboud | Nijmegen Gelderland, Netherlands, 6525 GAUniversitair Medisch Centrum Groningen | Groningen , Netherlands, 9713 GZUniversity Medical Center Utrecht | Utrecht , Netherlands, 3584 CXUniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa | Bialystok , Poland, 15-274Uniwersyteckie Centrum Kliniczne | Gdansk , Poland, 80-952Uniwersytecki Szpital Dzieciecy w Krakowie | Krakow , Poland, 30-663Instytut Centrum Zdrowia Matki Polki | Lodz , Poland, 93-338Dzieciecy Szpital Kliniczny im. Jozefa Brudzinskiego | Warsaw , Poland, 02-091Instytut "Pomnik - Centrum Zdrowia Dziecka" | Warsaw , Poland, 04-730Uniwersytecki Szpital Kliniczny UM we Wroclawiu | Wroclaw , Poland, 50-556Centro Clinico Academico Braga | Braga, Portugal | Braga , Portugal, 4710-243Hospital Pediátrico de Coimbra I ULS Coimbra | Coimbra , Portugal, 3000Hospital Santa Maria | Centro de Investigacao Clinica | Lisbon , Portugal, 1649-035Unidade Local de Saúde de Santo António, E.P.E | Porto , Portugal, 4050-651Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit | Soweto Gauteng, South Africa, 1862Kyungpook National University Hospital | Daegu Daegu Gwang''yeogsi, South Korea, 41944Seoul National University Bundang Hospital | Seongnam-si Gyeonggido, South Korea, 13620Pusan National University Yangsan Hospital | Yangsan Gyeongsangnam-do, South Korea, 50612Korea University Guro Hospital | Seoul Seoul Teugbyeolsi, South Korea, 152-703Seoul National University Hospital | Seoul Seoul Teugbyeolsi, South Korea, 3080Hospital Universitari Vall D Hebron | Nefrologia pediatrica | Barcelona , Spain, 08035Hospital Sant Joan De Deu Barcelona | Nefrologia pediatrica | Barcelona , Spain, 08950Hospital Universitario 12 De Octubre | Nefrologia pediatrica | Madrid , Spain, 28041Hospital Universitario La Paz | Nefrologia pediatrica | Madrid , Spain, 28046Hospital Universitario Regional De Malaga | Nefrologia pediatrica | Málaga , Spain, 29010Hospital Universitario Virgen Del Rocio S.L. | Nefrologia pediatrica | Seville , Spain, 41013Skånes Universitetssjukhus Lund - Barnnefroenheten | Lund Skåne County, Sweden, 221 85Karolinska University Hospital | Stockholm Stockholm County, Sweden, 141 86OBSOLETE_Uppsala University Hospital | Uppsala Uppsala County, Sweden, 751 85Universitäts-Kinderspital UKBB | Basel Canton of Basel-City, Switzerland, 4031Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne Canton of Vaud, Switzerland, 1012Hopital des Enfants HUG | Geneva , Switzerland, 1211Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch | Guishan Taoyuan, Taiwan, 83301Kaohsiung Veterans General Hospital | Kaohsiung City , Taiwan, 813414National Cheng Kung University Hospital | Tainan , Taiwan, 704National Taiwan University Hospital | Taipei , Taiwan, 100229Chang Gung Memorial Hospital at Linkou | Taipei , Taiwan, 10507Taipei Veterans General Hospital | Taipei , Taiwan, 11217Cukurova Univ. Tip. Fak. Balcali Hastanesi | Adana , Turkey (Türkiye), 01790Hacettepe Universitesi Tip Fakultesi | Ankara , Turkey (Türkiye), 06230Baskent Universitesi Tip Fakultesi Hastanesi | Ankara , Turkey (Türkiye), 6490Gazi Universitesi Tip Fakultesi | Ankara , Turkey (Türkiye), 6560T.C. Saglik Bakanligi Ankara Bilkent Sehir Hastanesi Noroloji ve Ortopedi Hastanesi Noroloji Bolumu | Ankara , Turkey (Türkiye), 6800Istanbul Faculty of Medicine, Department of Internal Medicine, Department of Pediatrics | Istanbul , Turkey (Türkiye), 34093Istanbul Universitesi Cerrahpasa - Cocuk Nefrolojisi | Istanbul , Turkey (Türkiye), 34098Marmara University Medical Faculty | Pediatric Nephrology | Istanbul , Turkey (Türkiye), 34899Great Ormond Street Hospital for Children NHS Foundation Trust | Great Ormond Street Hospital - Clinical Research Facility | London Greater London, United Kingdom, WC1N 3JHManchester University NHS Foundation Trust | Royal Manchester Children's Hospital - Clinical Research Facility | Manchester Greater Manchester, United Kingdom, M13 9WLNottingham University Hospitals NHS Trust | Queens Medical Centre - Childrens Clinical Research Facility | Nottingham Nottinghamshire, United Kingdom, NG7 2UHNHS Greater Glasgow and Clyde | Royal Hospital for Children - Glasgow Clinical Research Facility | Glasgow Scotland, United Kingdom, G51 4TFBirmingham Children's Hospital | Birmingham West Midlands, United Kingdom, B4 6NH