AzTrials
AzTrials

Chronic Kidney DiseasePhase 3FIONA OLENCT05457283

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

A Phase 3 study testing Finerenone (Kerendia, BAY94-8862) in people with Chronic Kidney Disease and Proteinuria, run by Bayer at 151 sites in 32 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 18 years
Conditions the study is for
Chronic Kidney Disease, Proteinuria, Children
What is being tested?
Finerenone (Kerendia, BAY94-8862)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
151 sitesin 32 countries
Study dates
8 Nov 2022to 31 Aug 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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

Trial locations and contacts

151 sites in 32 countries. Contact the study team or a site near you to ask about taking part.

Bayer Clinical Trials Contact contact

18888422937

clinical-trials-contact@bayer.com

151 sites in 32 countries

United States18 sites

  • Emory University Hospital/Children's Healthcare of Atlanta - Nephrology

    Atlanta, Georgia, 30322

    Withdrawn

  • The Charlotte R. Bloomberg Children's Center Building - Nephrology

    Baltimore, Maryland, 21287

    Active, not recruiting

  • Boston Children's Hospital - Main Campus - Nephrology

    Boston, Massachusetts, 02115

    Withdrawn

  • Cincinnati Children's Hospital Medical Center | Division of Nephrology and Hypertension

    Cincinnati, Ohio, 45229

    Withdrawn

  • Cleveland Clinic | Pediatric Nephrology

    Cleveland, Ohio, 14013

    Completed

  • Memorial Transplant Institute - Pediatric Nephrology

    Hollywood, Florida, 33021

    Withdrawn

  • University of Iowa Health Care Medical Center - Nephrology

    Iowa City, Iowa, 52242

    Withdrawn

  • Children's Mercy Hospital Kansas City - Nephrology

    Kansas City, Missouri, 64108

    Withdrawn

  • Cedars-Sinai Samuel Oschin Cancer Center

    Los Angeles, California, 90048

    Withdrawn

  • Lucille Packard Children's Hospital Stanford - Pediatric Nephrology

    Palo Alto, California, 94304

    Active, not recruiting

  • Children's Hospital of Philadelphia - Nephrology

    Philadelphia, Pennsylvania, 19104

    Withdrawn

  • Phoenix Children's Hospital | Main - Transplant Department

    Phoenix, Arizona, 85016

    Withdrawn

  • OHSU Doernbecher Children's Hospital - Neurology

    Portland, Oregon, 97239

    Withdrawn

  • Eccles Primary Children's Outpatient Services - Nephrology

    Salt Lake City, Utah, 84113

    Active, not recruiting

  • University Hospital - San Antonio - Pediatric Nephrology

    San Antonio, Texas, 78207

    Withdrawn

  • Rady Children's Hospital San Diego - Cardiology

    San Diego, California, 92123

    Withdrawn

  • Seattle Children's Hospital - Nephrology

    Seattle, Washington, 98105

    Withdrawn

  • Children's National Hospital - Nephrology

    Washington D.C., District of Columbia, 20010

    Withdrawn

Other trials in United States

Turkey (Türkiye)8 sites

  • Cukurova Univ. Tip. Fak. Balcali Hastanesi

    Adana, 01790

    Withdrawn

  • Hacettepe Universitesi Tip Fakultesi

    Ankara, 06230

    Withdrawn

  • Baskent Universitesi Tip Fakultesi Hastanesi

    Ankara, 6490

    Completed

  • Gazi Universitesi Tip Fakultesi

    Ankara, 6560

    Active, not recruiting

  • T.C. Saglik Bakanligi Ankara Bilkent Sehir Hastanesi Noroloji ve Ortopedi Hastanesi Noroloji Bolumu

    Ankara, 6800

    Active, not recruiting

  • Istanbul Faculty of Medicine, Department of Internal Medicine, Department of Pediatrics

    Istanbul, 34093

    Active, not recruiting

  • Istanbul Universitesi Cerrahpasa - Cocuk Nefrolojisi

    Istanbul, 34098

    Completed

  • Marmara University Medical Faculty | Pediatric Nephrology

    Istanbul, 34899

    Completed

Other trials in Turkey (Türkiye)

Germany7 sites

  • Charité / Pädiatrie

    Berlin, 13353

    Active, not recruiting

  • Kindernierenzentrum Bonn

    Bonn, North Rhine-Westphalia, 53127

    Active, not recruiting

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45147

    Active, not recruiting

  • Universitätsklinikum Hamburg Eppendorf (UKE)

    Hamburg, 20246

    Withdrawn

  • Medizinische Hochschule Hannover (MHH) | Zentrum Innere Medizin | Klinik fuer Kardiologie und Angiologie

    Hanover, Lower Saxony, 30625

    Withdrawn

  • Universitätsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69115

    Withdrawn

  • Universitätsklinikum Münster

    Münster, North Rhine-Westphalia, 48149

    Withdrawn

Other trials in Germany

Argentina6 sites, 1 recruiting

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199ABB

    Active, not recruiting

  • Hospital de Pediatría Juan P. Garrahan

    Buenos Aires, C1249ABN

    Withdrawn

  • Hospital General de Ninos Pedro de Elizalde | Nephrology Department

    Buenos Aires, C1270AAN

    Active, not recruiting

  • Hospital General de Ninos Ricardo Gutierrez | Pediatric Nephrology Department

    Buenos Aires, C1425EFD

    Recruiting

  • Centro de Rehabilitacion Cardiovascular | San Luis, Argentina

    San Luis, D5700CGR

    Active, not recruiting

  • Clinica de Nefrologia, Urologia y Enfermedades Cardiovascualares | Santa Fe, Argentina

    Santa Fe, Santa Fe Province, S3000

    Withdrawn

Other trials in Argentina

Brazil6 sites, 4 recruiting

  • Hospital Pequeno Principe

    Curitiba, Paraná, 80250-060

    Recruiting

  • Hosp Clínicas Facult. Med. de Ribeirão Preto / USP

    Ribeirão Preto, São Paulo, 14051-140

    Active, not recruiting

  • Hospital Infantil Sabará - Instituto PENSI - Pesquisa e Ensino em Saúde Infantil

    São Paulo, 01227-200

    Withdrawn

  • Instituto da Crianca e do Adolescente

    São Paulo, 05403 000

    Not yet recruiting

  • Hospital PUC-Campinas | Centro de Pesquisa Clínica Sao Lucas

    São Paulo, 13034-685

    Recruiting

  • Santa Casa de Misericórdia de Belo Horizonte

    São Paulo, 30150-221

    Recruiting

Other trials in Brazil

France6 sites

  • CHU bordeaux - Hopital Pellegrin

    Bordeaux, New Aquitaine, 33076

    Withdrawn

  • CHU Lyon - Hopital Femme Mere Enfant - Service de nephrologie-rhumatologie-dermatologie pediatriques

    Bron, 69500

    Completed

  • CHU Montpellier - Hopital Arnaud de Villeneuve - Service nephrologie pediatrique

    Montpellier, 34295

    Active, not recruiting

  • APHP - Hopital Robert Debre

    Paris, Île-de-France Region, 75019

    Active, not recruiting

  • CHU Strasbourg - Hopital Hautepierre - Service nephrologie pediatrique

    Strasbourg, 67200

    Withdrawn

  • CHU Toulouse - Hopital des enfants

    Toulouse, Occitanie, 31059

    Completed

Other trials in France

Italy6 sites, 2 recruiting

  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Pediatria

    Bologna, 40138

    Completed

  • Azienda Ospedaliera Universitaria Meyer IRCCS - Nefrologia e Dialisi

    Florence, 50139

    Recruiting

  • IRCCS Istituto Giannina Gaslini - Nefrologia e Trapianto Rene

    Genova, 16147

    Completed

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Nefrologia e Dialisi Pediatrica, Trapianti di Rene

    Milan, 20122

    Completed

  • Ospedale Pediatrico Bambino Gesù - Nefrologia

    Roma, 00165

    Completed

  • A.O.U. Città della Salute e della Scienza di Torino_Regina Margherita - Nefrologia Pediatrica

    Torino, 10126

    Recruiting

Other trials in Italy

Poland6 sites

  • Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa

    Bialystok, 15-274

    Completed

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

    Active, not recruiting

  • Uniwersytecki Szpital Dzieciecy w Krakowie

    Krakow, 30-663

    Withdrawn

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338

    Completed

  • Instytut "Pomnik - Centrum Zdrowia Dziecka"

    Warsaw, 04-730

    Active, not recruiting

  • Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu

    Wroclaw, 50-556

    Withdrawn

Other trials in Poland

Spain6 sites, 1 recruiting

  • Hospital Universitari Vall D Hebron | Nefrologia pediatrica

    Barcelona, 08035

    Active, not recruiting

  • Hospital Sant Joan De Deu Barcelona | Nefrologia pediatrica

    Esplugues de Llobregat, Barcelona, 8950

    Completed

  • Hospital Universitario 12 De Octubre | Nefrologia pediatrica

    Madrid, 28041

    Completed

  • Hospital Universitario La Paz | Nefrologia pediatrica

    Madrid, 28046

    Active, not recruiting

  • Hospital Universitario Regional De Malaga | Nefrologia pediatrica

    Málaga, 29010

    Recruiting

  • Hospital Universitario Virgen Del Rocio S.L. | Nefrologia pediatrica

    Seville, 41013

    Completed

Other trials in Spain

Taiwan6 sites, 2 recruiting

  • Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch

    Guishan, Taoyuan, 83301

    Not yet recruiting

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 813414

    Withdrawn

  • National Cheng Kung University Hospital

    Tainan, 704

    Withdrawn

  • National Taiwan University Hospital

    Taipei, 100229

    Withdrawn

  • Chang Gung Memorial Hospital at Linkou

    Taipei, 10507

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Active, not recruiting

Other trials in Taiwan

Belgium5 sites

  • Huderf / Ukzkf

    Brussels, Brussels Capital, 1020

    Withdrawn

  • CU Saint-Luc/UZ St-Luc

    Brussels, Brussels Capital, 1200

    Withdrawn

  • UZ Gent

    Ghent, East Flanders, 9000

    Active, not recruiting

  • UZ Gasthuisberg - Pediatric Nephrology

    Leuven, Flemish Brabant, 3000

    Completed

  • CHC Montlégia - Pediatrics

    Liège, 4000

    Withdrawn

Other trials in Belgium

Greece5 sites, 2 recruiting

  • Children's Hospital of Athens P&A Kyriakou - Pediatric Nephrology Department

    Athens, 11526

    Recruiting

  • Children's Hospital of Athens Agia Sofia - Pediatric Nephrology Department

    Athens, 11527

    Recruiting

  • University General Hospital of Heraklion

    Heraklion, 71110

    Active, not recruiting

  • University General Hospital Of Ioannina-Child Health Sector

    Ioannina, 45500

    Active, not recruiting

  • Ippokratio General Hospital Of Thessaloniki-Pediatric Nephrology Unit, 3rd Department of Paediatrics

    Thessaloniki, 54642

    Withdrawn

Other trials in Greece

Israel5 sites

  • Clalit Health | Soroka Medical Center

    Beersheba, 8410101

    Active, not recruiting

  • Wilf Children's Hospital Shaare Zedek Medical Center

    Jerusalem, 9103102

    Active, not recruiting

  • Health Corporation of Galilee Medical Center

    Nahariya, 2210001

    Completed

  • Clalit Health Services Schneider Children's Medical Center

    Petah Tikva, 4920235

    Completed

  • Dana-Dwek Children's Hospital

    Tel Aviv, 6423906

    Active, not recruiting

Other trials in Israel

Malaysia5 sites, 5 recruiting

  • Hospital Universiti Sains Malaysia

    Kelantan, Kelantan, 16150

    Recruiting

  • Hospital Tuanku Ja'afar

    Seremban, Negeri Sembilan, 70300

    Recruiting

  • Hospital Selayang

    Shah Alam, Selangor, 68100

    Recruiting

  • Sunway Medical Centre

    Subang Jaya, Selangor, 47500

    Recruiting

  • Hospital Tunku Azizah

    Wilayah Persekutuan Putrajaya, Kuala Lumpur, 50300

    Recruiting

Other trials in Malaysia

Mexico5 sites, 2 recruiting

  • Sitio Alfredo Chew Wong | Aguascalientes, Mexico

    Aguascalientes, Agguascalientes, 20124

    Recruiting

  • Hospital Infantil de México "Dr. Federico Gómez"

    México D.F., Mexico City, 6720

    Withdrawn

  • Instituto Nacional de Pediatría

    México, D.F., Mexico City, 4530

    Not yet recruiting

  • Hospital Universitario "José Eleuterio González"

    Monterrey, Nuevo León, 64460

    Withdrawn

  • Instituto Veracruzano en Investigación Clinica SC

    Veracruz, 91900

    Withdrawn

Other trials in Mexico

South Korea5 sites

  • Kyungpook National University Hospital | Pediatric Nephrology

    Daegu, 41944

    Completed

  • Seoul National University Bundang Hospital | Pediatric Nephrology

    Seongnam-si, Gyeonggi-do, 13620

    Completed

  • Seoul National University Hospital | Pediatric Nephrology

    Seoul, 03080

    Active, not recruiting

  • Korea University Guro Hospital | Pediatric Nephrology

    Seoul, 08308

    Withdrawn

  • Pusan National University Children's Hospital | Pediatric Nephrology

    Yangsan, Gyeongsangnam-do, 50612

    Active, not recruiting

Other trials in South Korea

Austria4 sites

  • Medizinische Universität Graz, Landeskrankenhaus-Universitätsklinikum Graz

    Graz, Styria, 8036

    Withdrawn

  • Kepler Universitätsklinikum Campus IV

    Innsbruck, Tyrol, 6020

    Completed

  • Uniklinikum Salzburg - Landeskrankenhaus

    Vienna, State of Vienna, 1090

    Withdrawn

  • Universitätsklinikum AKH Wien

    Vienna, State of Vienna, 1090

    Withdrawn

Other trials in Austria

Hungary4 sites

  • Semmelweis University

    Budapest, 1083

    Active, not recruiting

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, Hajdú-Bihar, 4032

    Completed

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, Baranya, 7623

    Completed

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

    Szeged, Csongrád-Csanád, 6720

    Withdrawn

Other trials in Hungary

India4 sites

  • Mavani Kidney Care

    Ahmedabad, Gujarat, 380052

    Active, not recruiting

  • St. John's National Academy of Health Sciences

    Bengaluru, Karnataka, 560034

    Active, not recruiting

  • All India Institute of Medical Sciences (AIIMS) - New Delhi

    Delhi, National Capital Territory of Delhi, 110029

    Active, not recruiting

  • NRS Medical college

    Kolkata, West Bengal, 700014

    Active, not recruiting

Other trials in India

United Kingdom4 sites, 2 recruiting

  • Royal Hospital for Children | Glasgow Clinical Research Facility

    Glasgow, Scotland, G51 4TF

    Recruiting

  • Great Ormond Street Hospital for Children | Clinical Research Facility

    London, Greater London, WC1N 3JH

    Active, not recruiting

  • Royal Manchester Children's Hospital | Clinical Research Facility

    Manchester, Greater Manchester, M13 9WL

    Recruiting

  • Nottingham Children's Hospital | Renal and Urology Unit

    Nottingham, Nottinghamshire, NG7 2UH

    Withdrawn

Other trials in United Kingdom

Australia3 sites, 1 recruiting

  • Monash Children's Hospital

    Clayton, Victoria, 3168

    Withdrawn

  • Royal Children's Hospital Melbourne

    Parkville, Victoria, 3052

    Recruiting

  • Queensland Children's Hospital

    South Brisbane, Queensland, 4101

    Active, not recruiting

Other trials in Australia

Bulgaria3 sites, 1 recruiting

  • UMHAT Sveti Georgi

    Plovdiv, Plovdiv Province, 4002

    Recruiting

  • SHATPD "Prof. Ivan Mitev"

    Sofia, Sofia City Province, 1606

    Withdrawn

  • MHAT prof. Stoyan Kirkovitch AD

    Stara Zagora, Stara Zagora Province, 6003

    Withdrawn

Other trials in Bulgaria

Denmark3 sites

  • Aarhus Universitetshospital - Børn og Unge

    Aarhus N, Central Denmark Region / Region Midtjylland, 8200

    Completed

  • Rigshospitalet - Børn og Unge

    Copenhagen, Capital Region / Region Hovedstaden, 2100

    Withdrawn

  • Odense Universitetshospital - HC Andersen Børne og Ungehospital

    Odense, Region of Southern Denmark / Region Syddanmark, 5000

    Active, not recruiting

Other trials in Denmark

Finland3 sites, 2 recruiting

  • HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Uusi lastensairaala, nefrologia

    Helsinki, Uusimaa, 00290

    Recruiting

  • Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS) - Lasten lääketutkimuskeskus PeeTU

    Tampere, Pirkanmaa, 33521

    Recruiting

  • Turun yliopistollinen keskussairaala

    Turku, Southwest Finland, 20520

    Withdrawn

Other trials in Finland

Portugal3 sites

  • Unidade Local de Saúde de Braga E.P.E. - Centro Clínico Académico de Braga - Serviço de Pediatria

    Braga, 4710-243

    Withdrawn

  • Unidade Local de Saúde de Coimbra, E.P.E. - Hospital Pediátrico - Serviço de Pediatria Ambulatória - Nefrologia

    Coimbra, 3000

    Completed

  • Unidade Local de Saúde de Santo António, E.P.E

    Porto, 4050-651

    Completed

Other trials in Portugal

Sweden3 sites

  • Skånes Universitetssjukhus - Lund - Barnnefroenheten

    Lund, Skåne County, 221 85

    Active, not recruiting

  • Karolinska Universitetssjukhuset - Huddinge - Barnnjurmedicin

    Stockholm - Huddinge, 141 86

    Withdrawn

  • OBSOLETE_Uppsala University Hospital

    Uppsala, Uppsala County, 751 85

    Withdrawn

Other trials in Sweden

Switzerland3 sites

  • Universitäts-Kinderspital UKBB

    Basel, Canton of Basel-City, 4031

    Active, not recruiting

  • Hopital des Enfants HUG

    Geneva, 1211

    Completed

  • Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne University Hospital

    Lausanne, Canton of Vaud, 1012

    Active, not recruiting

Other trials in Switzerland

Canada2 sites

  • Alberta Children's Hospital | Nephrology Clinic

    Calgary, Alberta, T3B 6A8

    Withdrawn

  • Centre hospitalier universitaire Sainte-Justine | Cardiology

    Montreal, Quebec, H3T 1C5

    Completed

Other trials in Canada

Czechia2 sites

  • Všeobecná fakultní nemocnice v Praze

    Prague, Prague, 128 08

    Completed

  • Fakultní nemocnice Motol a Homolka, Pracoviště MOTOL

    Prague, Prague, 150 06

    Active, not recruiting

Other trials in Czechia

Lithuania2 sites

  • Hospital of LT University of Health Sciences Kaunas Clinics

    Kaunas, Kaunas County, LT-50161

    Active, not recruiting

  • Vilnius University Hospital Santaros Klinikos Children's Hospital Paediatrics Centre

    Vilnius, Vilnius County, LT-08406

    Active, not recruiting

Other trials in Lithuania

Netherlands2 sites

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

    Active, not recruiting

  • University Medical Center Utrecht

    Utrecht, 3584 CX

    Active, not recruiting

Other trials in Netherlands

South Africa1 site, 1 recruiting

  • Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit

    Soweto, Gauteng, 1862

    Recruiting

Other trials in South Africa

About this study

Official title: 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

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.

Read more

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.

Being tested
Finerenone (Kerendia, BAY94-8862)
Medical subject headings
Renal Insufficiency, Chronic, Proteinuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Finerenone (Kerendia, BAY94-8862)Drug

    Finerenone in different doses, treatment duration will be 540 ±7 days.

Study groups in NCT05457283
Study groupRoleWhat they receive
Finerenone Open-Label safety ExtensionExperimentalParticipants will receive finerenone treatment.
Receives: Drug: Finerenone (Kerendia, BAY94-8862)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with treatment emergent adverse event (TEAEs)

    Measured: Up to 550 days

  2. Change in serum potassium levels from baseline to Day 540±7

    Measured: Up to 547 days

  3. Change in systolic blood pressure (SBP) from baseline to Day 540±7

    Measured: Up to 547 days

Secondary outcomes (3)

  1. Change in urinary protein-to-creatinine ratio (UPCR) from baseline to Day 540±7

    Measured: Up to 547 days

  2. Change in urinary albumin-to-creatinine ratio (UACR) from baseline to Day 540±7

    Measured: Up to 547 days

  3. Change in estimated glomerular filtration rate (eGFR) from baseline to Day 540±7

    Measured: Up to 547 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2022
  2. Study start8 Nov 2022
  3. Primary completion7 Aug 2028 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05457283
Sponsor's protocol ID
20186
Other IDs
2023-504885-50-00, 2021-002905-89, 2023
Acronym
FIONA OLE
Status last verified
22 Sep 2026
First submitted
11 Jul 2022
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Finerenone (Kerendia, BAY94-8862) in people with Chronic Kidney Disease and Proteinuria, run by Bayer at 151 sites in 32 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 151 sites in United States, Turkey (Türkiye), Germany, Argentina, Brazil and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bayer Clinical Trials Contact (18888422937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment emergent adverse event (TEAEs) (time frame: Up to 550 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05457283.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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