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 (FIONA OLE)
August 19, 2026 updated by: Bayer
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.
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bayer Clinical Trials Contact
- Phone Number: 18888422937
- Email: clinical-trials-contact@bayer.com
Study Locations
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Buenos Aires, Argentina, C1199ABB
- Active, not recruiting
- Hospital Italiano de Buenos Aires
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Buenos Aires, Argentina, C1425EFD
- Recruiting
- Hospital General de Ninos Ricardo Gutierrez | Pediatric Nephrology Department
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Buenos Aires, Argentina, C1270AAN
- Active, not recruiting
- Hospital General de Ninos Pedro de Elizalde | Nephrology Department
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San Luis, Argentina, D5700CGR
- Active, not recruiting
- Centro de Rehabilitacion Cardiovascular | San Luis, Argentina
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Santa Fe Province
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Santa Fe, Santa Fe Province, Argentina, S3000
- Withdrawn
- Clinica de Nefrologia, Urologia y Enfermedades Cardiovascualares | Santa Fe, Argentina
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Queensland
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South Brisbane, Queensland, Australia, 4101
- Recruiting
- Queensland Children's Hospital
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Victoria
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Clayton, Victoria, Australia, 3168
- Withdrawn
- Monash Children's Hospital
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Parkville, Victoria, Australia, 3052
- Recruiting
- Royal Children's Hospital Melbourne
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State of Vienna
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Vienna, State of Vienna, Austria, 1090
- Withdrawn
- Uniklinikum Salzburg - Landeskrankenhaus
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Vienna, State of Vienna, Austria, 1090
- Withdrawn
- Universitätsklinikum AKH Wien
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Styria
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Graz, Styria, Austria, 8036
- Withdrawn
- Medizinische Universität Graz, Landeskrankenhaus-Universitätsklinikum Graz
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Tyrol
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Innsbruck, Tyrol, Austria, 6020
- Completed
- Kepler Universitätsklinikum Campus IV
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Liège, Belgium, 4000
- Withdrawn
- CHC Montlégia - Pediatrics
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Brussels Capital
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Brussels, Brussels Capital, Belgium, 1020
- Withdrawn
- Huderf / Ukzkf
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Brussels, Brussels Capital, Belgium, 1200
- Withdrawn
- CU Saint-Luc/UZ St-Luc
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East Flanders
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Ghent, East Flanders, Belgium, 9000
- Active, not recruiting
- Uz Gent
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Flemish Brabant
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Leuven, Flemish Brabant, Belgium, 3000
- Completed
- UZ Gasthuisberg - Pediatric Nephrology
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São Paulo, Brazil, 05403 000
- Not yet recruiting
- Instituto da Crianca e do Adolescente
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São Paulo, Brazil, 13034-685
- Recruiting
- Hospital PUC-Campinas | Centro de Pesquisa Clínica Sao Lucas
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São Paulo, Brazil, 30150-221
- Recruiting
- Santa Casa de Misericordia de Belo Horizonte
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Paraná
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Curitiba, Paraná, Brazil, 80250-060
- Not yet recruiting
- Hospital Pequeno Principe
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São Paulo
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Ribeirão Preto, São Paulo, Brazil, 14051-140
- Recruiting
- Hosp Clínicas Facult. Med. de Ribeirão Preto / USP
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Plovdiv Province
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Plovdiv, Plovdiv Province, Bulgaria, 4002
- Not yet recruiting
- UMHAT Sveti Georgi
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Alberta
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Calgary, Alberta, Canada, T3B 6A8
- Withdrawn
- Alberta Children's Hospital | Nephrology Clinic
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Quebec
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Montreal, Quebec, Canada, H3T 1C5
- Recruiting
- Centre hospitalier universitaire Sainte-Justine | Cardiology
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Prague
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Prague, Prague, Czechia, 128 08
- Completed
- Vseobecna Fakultni nemocnice v Praze
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Prague, Prague, Czechia, 150 06
- Active, not recruiting
- Fakultní nemocnice Motol a Homolka, Pracoviště MOTOL
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Capital Region / Region Hovedstaden
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Copenhagen, Capital Region / Region Hovedstaden, Denmark, 2100
- Withdrawn
- Rigshospitalet - Børn og Unge
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Central Denmark Region / Region Midtjylland
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Aarhus N, Central Denmark Region / Region Midtjylland, Denmark, 8200
- Completed
- Aarhus Universitetshospital - Børn og Unge
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Region of Southern Denmark / Region Syddanmark
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Odense, Region of Southern Denmark / Region Syddanmark, Denmark, 5000
- Active, not recruiting
- Odense Universitetshospital - HC Andersen Børne og Ungehospital
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Pirkanmaa
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Tampere, Pirkanmaa, Finland, 33521
- Recruiting
- Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS) - Lasten lääketutkimuskeskus PeeTU
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Southwest Finland
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Turku, Southwest Finland, Finland, 20520
- Withdrawn
- Turun yliopistollinen keskussairaala
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Uusimaa
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Helsinki, Uusimaa, Finland, 00290
- Recruiting
- HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Uusi lastensairaala, nefrologia
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-
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Bron, France, 69500
- Completed
- CHU Lyon - Hopital Femme Mere Enfant - Service de nephrologie-rhumatologie-dermatologie pediatriques
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Montpellier, France, 34295
- Active, not recruiting
- CHU Montpellier - Hopital Arnaud de Villeneuve - Service nephrologie pediatrique
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Strasbourg, France, 67200
- Withdrawn
- CHU Strasbourg - Hopital Hautepierre - Service nephrologie pediatrique
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New Aquitaine
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Bordeaux, New Aquitaine, France, 33076
- Withdrawn
- CHU bordeaux - Hopital Pellegrin
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Occitanie
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Toulouse, Occitanie, France, 31059
- Completed
- CHU Toulouse - Hopital des enfants
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Île-de-France Region
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Paris, Île-de-France Region, France, 75019
- Active, not recruiting
- APHP - Hopital Robert Debre
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Berlin, Germany, 13353
- Active, not recruiting
- Charité / Pädiatrie
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Hamburg, Germany, 20246
- Withdrawn
- Universitätsklinikum Hamburg Eppendorf (UKE)
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Baden-Wurttemberg
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Heidelberg, Baden-Wurttemberg, Germany, 69115
- Withdrawn
- Universitatsklinikum Heidelberg
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Lower Saxony
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Hanover, Lower Saxony, Germany, 30625
- Withdrawn
- Medizinische Hochschule Hannover (MHH) | Zentrum Innere Medizin | Klinik fuer Kardiologie und Angiologie
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North Rhine-Westphalia
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Bonn, North Rhine-Westphalia, Germany, 53127
- Active, not recruiting
- Kindernierenzentrum Bonn
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Essen, North Rhine-Westphalia, Germany, 45147
- Active, not recruiting
- Universitatsklinikum Essen
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Münster, North Rhine-Westphalia, Germany, 48149
- Withdrawn
- Universitatsklinikum Munster
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Athens, Greece, 11527
- Recruiting
- Children's Hospital of Athens Agia Sofia - Pediatric Nephrology Department
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Athens, Greece, 11526
- Recruiting
- Children's Hospital of Athens P&A Kyriakou - Pediatric Nephrology Department
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Heraklion, Greece, 71110
- Active, not recruiting
- University General Hospital of Heraklion
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Ioannina, Greece, 45500
- Active, not recruiting
- University General Hospital Of Ioannina-Child Health Sector
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Thessaloniki, Greece, 54642
- Withdrawn
- Ippokratio General Hospital Of Thessaloniki-Pediatric Nephrology Unit, 3rd Department of Paediatrics
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Budapest, Hungary, 1083
- Active, not recruiting
- Semmelweis University
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Baranya
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Pécs, Baranya, Hungary, 7623
- Completed
- Pécsi Tudományegyetem Klinikai Központ
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Csongrád-Csanád
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Szeged, Csongrád-Csanád, Hungary, 6720
- Withdrawn
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
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Hajdú-Bihar
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Debrecen, Hajdú-Bihar, Hungary, 4032
- Completed
- Debreceni Egyetem Klinikai Kozpont
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Gujarat
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Ahmedabad, Gujarat, India, 380052
- Active, not recruiting
- Mavani Kidney Care
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Karnataka
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Bengaluru, Karnataka, India, 560034
- Active, not recruiting
- St. John's National Academy of Health Sciences
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National Capital Territory of Delhi
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Delhi, National Capital Territory of Delhi, India, 110029
- Active, not recruiting
- All India Institute of Medical Sciences (AIIMS) - New Delhi
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West Bengal
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Kolkata, West Bengal, India, 700014
- Active, not recruiting
- NRS Medical college
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Beersheba, Israel, 8410101
- Active, not recruiting
- Clalit Health | Soroka Medical Center
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Jerusalem, Israel, 9103102
- Active, not recruiting
- Wilf Children's Hospital Shaare Zedek Medical Center
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Nahariya, Israel, 2210001
- Completed
- Health Corporation of Galilee Medical Center
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Petah Tikva, Israel, 4920235
- Completed
- Clalit Health Services Schneider Children's Medical Center
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Tel Aviv, Israel, 6423906
- Active, not recruiting
- Dana-Dwek Children's Hospital
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Bologna, Italy, 40138
- Completed
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Pediatria
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Florence, Italy, 50139
- Recruiting
- Azienda Ospedaliera Universitaria Meyer IRCCS - Nefrologia e Dialisi
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Genova, Italy, 16147
- Completed
- IRCCS Istituto Giannina Gaslini - Nefrologia e Trapianto Rene
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Milan, Italy, 20122
- Completed
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Nefrologia e Dialisi Pediatrica, Trapianti di Rene
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Roma, Italy, 00165
- Completed
- Ospedale Pediatrico Bambino Gesù - Nefrologia
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Torino, Italy, 10126
- Recruiting
- A.O.U. Città della Salute e della Scienza di Torino_Regina Margherita - Nefrologia Pediatrica
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Kaunas County
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Kaunas, Kaunas County, Lithuania, LT-50161
- Active, not recruiting
- Hospital of LT University of Health Sciences Kaunas Clinics
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Vilnius County
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Vilnius, Vilnius County, Lithuania, LT-08406
- Active, not recruiting
- Vilnius University Hospital Santaros Klinikos Children's Hospital Paediatrics Centre
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Kelantan
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Kelantan, Kelantan, Malaysia, 16150
- Recruiting
- Hospital Universiti Sains Malaysia
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Kuala Lumpur
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Wilayah Persekutuan Putrajaya, Kuala Lumpur, Malaysia, 50300
- Recruiting
- Hospital Tunku Azizah
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Negeri Sembilan
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Seremban, Negeri Sembilan, Malaysia, 70300
- Recruiting
- Hospital Tuanku Ja'afar
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Selangor
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Shah Alam, Selangor, Malaysia, 68100
- Recruiting
- Hospital Selayang
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Subang Jaya, Selangor, Malaysia, 47500
- Recruiting
- Sunway Medical Centre
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Agguascalientes
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Aguascalientes, Agguascalientes, Mexico, 20124
- Not yet recruiting
- Sitio Alfredo Chew Wong | Aguascalientes, Mexico
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Mexico City
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México, D.F., Mexico City, Mexico, 4530
- Not yet recruiting
- Instituto Nacional de Pediatría
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Groningen, Netherlands, 9713 GZ
- Active, not recruiting
- Universitair Medisch Centrum Groningen
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Utrecht, Netherlands, 3584 CX
- Active, not recruiting
- University Medical Center Utrecht
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-
-
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Bialystok, Poland, 15-274
- Completed
- Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa
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Gdansk, Poland, 80-952
- Active, not recruiting
- Uniwersyteckie Centrum Kliniczne
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Lodz, Poland, 93-338
- Completed
- Instytut Centrum Zdrowia Matki Polki
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Warsaw, Poland, 04-730
- Active, not recruiting
- Instytut "Pomnik - Centrum Zdrowia Dziecka"
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Coimbra, Portugal, 3000
- Completed
- Unidade Local de Saúde de Coimbra, E.P.E. - Hospital Pediátrico - Serviço de Pediatria Ambulatória - Nefrologia
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Porto, Portugal, 4050-651
- Completed
- Unidade Local de Saúde de Santo António, E.P.E
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Gauteng
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Soweto, Gauteng, South Africa, 1862
- Recruiting
- Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit
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Daegu, South Korea, 41944
- Completed
- Kyungpook National University Hospital | Pediatric Nephrology
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Seoul, South Korea, 03080
- Recruiting
- Seoul National University Hospital | Pediatric Nephrology
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, South Korea, 13620
- Completed
- Seoul National University Bundang Hospital | Pediatric Nephrology
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Gyeongsangnam-do
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Yangsan, Gyeongsangnam-do, South Korea, 50612
- Recruiting
- Pusan National University Children's Hospital | Pediatric Nephrology
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Barcelona, Spain, 08035
- Active, not recruiting
- Hospital Universitari Vall D Hebron | Nefrologia pediatrica
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Madrid, Spain, 28041
- Completed
- Hospital Universitario 12 De Octubre | Nefrologia pediatrica
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Madrid, Spain, 28046
- Active, not recruiting
- Hospital Universitario La Paz | Nefrologia pediatrica
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Málaga, Spain, 29010
- Recruiting
- Hospital Universitario Regional De Malaga | Nefrologia pediatrica
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Seville, Spain, 41013
- Completed
- Hospital Universitario Virgen Del Rocio S.L. | Nefrologia pediatrica
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Barcelona
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Esplugues de Llobregat, Barcelona, Spain, 8950
- Completed
- Hospital Sant Joan De Deu Barcelona | Nefrologia pediatrica
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Stockholm - Huddinge, Sweden, 141 86
- Withdrawn
- Karolinska Universitetssjukhuset - Huddinge - Barnnjurmedicin
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Skåne County
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Lund, Skåne County, Sweden, 221 85
- Active, not recruiting
- Skånes Universitetssjukhus - Lund - Barnnefroenheten
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Geneva, Switzerland, 1211
- Recruiting
- Hopital des Enfants HUG
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Canton of Basel-City
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Basel, Canton of Basel-City, Switzerland, 4031
- Recruiting
- Universitäts-Kinderspital UKBB
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Canton of Vaud
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Lausanne, Canton of Vaud, Switzerland, 1012
- Recruiting
- Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne University Hospital
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Taipei, Taiwan, 11217
- Active, not recruiting
- Taipei Veterans General Hospital
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Taipei, Taiwan, 10507
- Recruiting
- Chang Gung Memorial Hospital at Linkou
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Taipei, Taiwan, 100229
- Withdrawn
- National Taiwan University Hospital
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Taoyuan
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Guishan, Taoyuan, Taiwan, 83301
- Not yet recruiting
- Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch
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Adana, Turkey (Türkiye), 01790
- Not yet recruiting
- Cukurova Univ. Tip. Fak. Balcali Hastanesi
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Ankara, Turkey (Türkiye), 6490
- Recruiting
- Baskent Universitesi Tip Fakultesi Hastanesi
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Ankara, Turkey (Türkiye), 6560
- Recruiting
- Gazi Universitesi Tip Fakultesi
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Ankara, Turkey (Türkiye), 6800
- Recruiting
- T.C. Saglik Bakanligi Ankara Bilkent Sehir Hastanesi Noroloji ve Ortopedi Hastanesi Noroloji Bolumu
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Ankara, Turkey (Türkiye), 06230
- Withdrawn
- Hacettepe Universitesi Tip Fakultesi
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Istanbul, Turkey (Türkiye), 34098
- Recruiting
- Istanbul Universitesi Cerrahpasa - Cocuk Nefrolojisi
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Istanbul, Turkey (Türkiye), 34899
- Recruiting
- Marmara University Medical Faculty | Pediatric Nephrology
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Istanbul, Turkey (Türkiye), 34093
- Recruiting
- Istanbul Faculty of Medicine, Department of Internal Medicine, Department of Pediatrics
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Greater London
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London, Greater London, United Kingdom, WC1N 3JH
- Active, not recruiting
- Great Ormond Street Hospital for Children | Clinical Research Facility
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Greater Manchester
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Manchester, Greater Manchester, United Kingdom, M13 9WL
- Recruiting
- Royal Manchester Children's Hospital | Clinical Research Facility
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Nottinghamshire
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Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
- Withdrawn
- Nottingham Children's Hospital | Renal and Urology Unit
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Scotland
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Glasgow, Scotland, United Kingdom, G51 4TF
- Recruiting
- Royal Hospital for Children | Glasgow Clinical Research Facility
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-
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California
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Palo Alto, California, United States, 94304
- Active, not recruiting
- Lucille Packard Children's Hospital Stanford - Pediatric Nephrology
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San Diego, California, United States, 92123
- Withdrawn
- Rady Children's Hospital San Diego - Cardiology
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District of Columbia
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Washington D.C., District of Columbia, United States, 20010
- Withdrawn
- Children's National Hospital - Nephrology
-
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Florida
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Hollywood, Florida, United States, 33021
- Withdrawn
- Memorial Transplant Institute - Pediatric Nephrology
-
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Iowa
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Iowa City, Iowa, United States, 52242
- Withdrawn
- University of Iowa Health Care Medical Center - Nephrology
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Maryland
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Baltimore, Maryland, United States, 21287
- Active, not recruiting
- The Charlotte R. Bloomberg Children's Center Building - Nephrology
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Missouri
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Kansas City, Missouri, United States, 64108
- Withdrawn
- Children's Mercy Hospital Kansas City - Nephrology
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Ohio
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Cincinnati, Ohio, United States, 45229
- Withdrawn
- Cincinnati Children's Hospital Medical Center | Division of Nephrology and Hypertension
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Cleveland, Ohio, United States, 14013
- Completed
- Cleveland Clinic | Pediatric Nephrology
-
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Oregon
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Portland, Oregon, United States, 97239
- Withdrawn
- OHSU Doernbecher Children's Hospital - Neurology
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Withdrawn
- Children's Hospital of Philadelphia - Nephrology
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Texas
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San Antonio, Texas, United States, 78207
- Withdrawn
- University Hospital - San Antonio - Pediatric Nephrology
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Utah
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Salt Lake City, Utah, United States, 84113
- Active, not recruiting
- Eccles Primary Children's Outpatient Services - Nephrology
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Washington
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Seattle, Washington, United States, 98105
- Withdrawn
- Seattle Children's Hospital - Nephrology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Finerenone Open-Label safety Extension
Participants will receive finerenone treatment.
|
Finerenone in different doses, treatment duration will be 540 ±7 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of participants with treatment emergent adverse event (TEAEs)
Time Frame: Up to 550 days
|
Up to 550 days
|
|
Change in serum potassium levels from baseline to Day 540±7
Time Frame: Up to 547 days
|
Up to 547 days
|
|
Change in systolic blood pressure (SBP) from baseline to Day 540±7
Time Frame: Up to 547 days
|
Up to 547 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in urinary protein-to-creatinine ratio (UPCR) from baseline to Day 540±7
Time Frame: Up to 547 days
|
Up to 547 days
|
|
Change in urinary albumin-to-creatinine ratio (UACR) from baseline to Day 540±7
Time Frame: Up to 547 days
|
Up to 547 days
|
|
Change in estimated glomerular filtration rate (eGFR) from baseline to Day 540±7
Time Frame: Up to 547 days
|
Up to 547 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 8, 2022
Primary Completion (Estimated)
October 8, 2028
Study Completion (Estimated)
November 7, 2028
Study Registration Dates
First Submitted
July 11, 2022
First Submitted That Met QC Criteria
July 11, 2022
First Posted (Actual)
July 13, 2022
Study Record Updates
Last Update Posted (Actual)
August 20, 2026
Last Update Submitted That Met QC Criteria
August 19, 2026
Last Verified
July 22, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Urination Disorders
- Urological Manifestations
- Renal Insufficiency
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Renal Insufficiency, Chronic
- Proteinuria
- finerenone
Other Study ID Numbers
- 20186
- 2021-002905-89 (EudraCT Number)
- 2023-504885-50-00 (Registry Identifier: CTIS (EU))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.