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)

April 19, 2024 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

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1199ABB
        • Not yet recruiting
        • Hospital Italiano de Buenos Aires
      • Ciudad de Buenos Aires, Argentina, C1270AAN
        • Not yet recruiting
        • Hospital General de Niños Pedro de Elizalde
      • Multiple Locations, Argentina
        • Not yet recruiting
        • Many Locations
      • San Luis, Argentina, D5700CGR
        • Not yet recruiting
        • Centro de Rehabilitacion Cardiovascular | San Luis, Argentina
      • Santa Fe, Argentina, S3000
        • Not yet recruiting
        • Clinica de Nefrologia, Urologia y Enfermedades Cardiovascualares - Santa Fe, Argentina
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, 1900
        • Withdrawn
        • Hospital de Niños Sor María Ludovica
    • Ciudad Auton. De Buenos Aires
      • Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1425EFD
        • Not yet recruiting
        • Hospital de Niños "Ricardo Gutiérrez"
  • Australia
      • Multiple Locations, Australia
        • Not yet recruiting
        • Many Locations
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Recruiting
        • Queensland Children's Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Not yet recruiting
        • Monash Children's Hospital
      • Parkville, Victoria, Australia, 3052
        • Not yet recruiting
        • Royal Children's Hospital Melbourne
  • Austria
      • Multiple Locations, Austria
        • Recruiting
        • Many Locations
      • Salzburg, Austria, 5020
        • Not yet recruiting
        • Uniklinikum Salzburg - Landeskrankenhaus
      • Wien, Austria, 1090
        • Not yet recruiting
        • Universitätsklinikum AKH Wien
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4020
        • Recruiting
        • Kepler Universitätsklinikum Campus IV
    • Steiermark
      • Graz, Steiermark, Austria, 8036
        • Not yet recruiting
        • Medizinische Universität Graz
  • Belgium
      • Bruxelles - Brussel, Belgium, 1200
        • Not yet recruiting
        • CU Saint-Luc/UZ St-Luc
      • Bruxelles - Brussel, Belgium, 1020
        • Not yet recruiting
        • Huderf / Ukzkf
      • Gent, Belgium, 9000
        • Recruiting
        • UZ Gent
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Gasthuisberg - Pediatric Nephrology
      • Liège, Belgium, 4000
        • Not yet recruiting
        • CHC Montlégia - Pediatrics
      • Multiple Locations, Belgium
        • Recruiting
        • Many Locations
  • Canada
      • Multiple Locations, Canada
        • Not yet recruiting
        • Many Locations
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Not yet recruiting
        • Alberta Children's Hospital, University of Calgary
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Not yet recruiting
        • The Hospital for Sick Children (SickKids)
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Not yet recruiting
        • CHU Sainte-Justine
  • Czechia
      • Multiple Locations, Czechia
        • Recruiting
        • Many Locations
      • Praha 2, Czechia, 12808
        • Recruiting
        • Vseobecna fakultni nemocnice v Praze
      • Praha 5, Czechia, 150 06
        • Not yet recruiting
        • Fakultni nemocnice v Motole
  • Denmark
      • Copenhagen, Denmark, 2100
        • Not yet recruiting
        • Rigshospitalet, Dept Pediatrics & Adelescent Med.
      • Multiple Locations, Denmark
        • Recruiting
        • Many Locations
      • Odense C, Denmark, 5000
        • Recruiting
        • Odense, HC Andersen
      • Århus N, Denmark, 8200
        • Recruiting
        • Aarhus Universitetshospital, Skejby
  • Finland
      • Helsinki, Finland, 00290
        • Recruiting
        • HUS Uusi lastensairaala
      • Multiple Locations, Finland
        • Recruiting
        • Many Locations
      • Tampere, Finland, 33521
        • Recruiting
        • Pediatric Early Phase Trial Unit, Tampere University Hospita
      • Turku, Finland, 20520
        • Not yet recruiting
        • Turun yliopistollinen keskussairaala
  • France
      • Bordeaux, France, 33000
        • Not yet recruiting
        • Hôpital Pellegrin - Bordeaux
      • Bron, France, 69677
        • Recruiting
        • CHU de Lyon - Hopital Femme Mère Enfant
      • Montpellier, France, 34059
        • Not yet recruiting
        • Hôpital Arnaud de Villeneuve - Montpellier
      • Multiple Locations, France
        • Recruiting
        • Many Locations
      • Paris, France, 75019
        • Recruiting
        • Hôpital Robert Debré
      • Strasbourg, France, 67098
        • Not yet recruiting
        • CHU STRASBOURG - Hôpital de Hautepierre
      • TOULOUSE Cedex 9, France, 31059
        • Recruiting
        • Hôpital Des Enfants
  • Germany
      • Berlin, Germany, 13353
        • Not yet recruiting
        • Charité / Pädiatrie
      • Hamburg, Germany, 20246
        • Not yet recruiting
        • Universitätsklinikum Hamburg Eppendorf (UKE)
      • Multiple Locations, Germany
        • Recruiting
        • Many Locations
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • Not yet recruiting
        • UniversitatsKlinikum Heidelberg
    • Bayern
      • Erlangen, Bayern, Germany, 91054
        • Withdrawn
        • Universitatsklinikum Erlangen
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Not yet recruiting
        • Medizinische Hochschule Hannover (MHH)
    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Germany, 53127
        • Not yet recruiting
        • Kindernierenzentrum Bonn
      • Bonn, Nordrhein-Westfalen, Germany, 53127
        • Withdrawn
        • Kindernierenzentrum Bonn
      • Essen, Nordrhein-Westfalen, Germany, 45147
        • Recruiting
        • Universitatsklinikum Essen
      • Münster, Nordrhein-Westfalen, Germany, 48149
        • Not yet recruiting
        • Universitätsklinikum Münster (UKM)
  • Greece
      • Athens, Greece
        • Recruiting
        • Children's Hospital of Athens P&A Kyriakou
      • Athens, Greece, 11527
        • Not yet recruiting
        • AGIA SOFIA Children's Hospital
      • Crete, Greece, 71500
        • Not yet recruiting
        • University General Hospital of Heraklion
      • Ioannina, Greece, 45500
        • Recruiting
        • Ioannina University General Hospital
      • Multiple Locations, Greece
        • Recruiting
        • Many Locations
      • Thessaloniki, Greece
        • Not yet recruiting
        • Hippokration General Hospital of Thessaloniki
  • Hungary
      • Budapest, Hungary, 1083
        • Not yet recruiting
        • Semmelweis University
      • Debrecen, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem Klinikai Kozpont
      • Multiple Locations, Hungary
        • Recruiting
        • Many Locations
      • Pecs, Hungary, 7623
        • Not yet recruiting
        • Pécsi Tudományegyetem Klinikai Központ
      • Szeged, Hungary, 6720
        • Not yet recruiting
        • SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
  • Israel
      • Beer Sheva, Israel, 8410101
        • Not yet recruiting
        • Soroka University Medical Center
      • Jerusalem, Israel, 9103102
        • Not yet recruiting
        • Wilf Children's Hospital Shaare Zedek Medical Center
      • Multiple Locations, Israel
        • Recruiting
        • Many Locations
      • Nahariya, Israel, 2210001
        • Recruiting
        • Health Corporation of Galilee Medical Center
      • Petach Tikva, Israel, 4920235
        • Recruiting
        • Clalit Health Services Schneider Children's Medical Center
      • Tel Aviv, Israel, 6423906
        • Not yet recruiting
        • Dana-Dwek Children's Hospital
  • Italy
      • Multiple Locations, Italy
        • Recruiting
        • Many Locations
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Recruiting
        • A.O.U. di Bologna Policlinico S.Orsola Malpighi
    • Lazio
      • Roma, Lazio, Italy, 00165
        • Recruiting
        • IRCCS Ospedale Pediatrico Bambino Gesù
    • Liguria
      • Genova, Liguria, Italy, 16147
        • Recruiting
        • IRCCS Istituto Giannina Gaslini
    • Lombardia
      • Milano, Lombardia, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Korea, Republic of
      • Multiple Locations, Korea, Republic of
        • Recruiting
        • Many Locations
    • Daegu Gwang''yeogsi
      • Daegu, Daegu Gwang''yeogsi, Korea, Republic of, 41944
        • Recruiting
        • Kyungpook National University Hospital
    • Gyeonggido
      • Seongnam-si, Gyeonggido, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
    • Gyeongsangnamdo
      • Yangsan-si, Gyeongsangnamdo, Korea, Republic of, 50612
        • Recruiting
        • Pusan National University Yangsan Hospital
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 3080
        • Recruiting
        • Seoul National University Hospital
  • Lithuania
      • Kaunas, Lithuania, LT-50161
        • Not yet recruiting
        • Hospital of LT University of Health Sciences Kaunas Clinics
      • Klaipeda, Lithuania, LT-92140
        • Withdrawn
        • Klaipeda Children's Hospital
      • Multiple Locations, Lithuania
        • Recruiting
        • Many Locations
      • Vilnius, Lithuania, LT-08406
        • Recruiting
        • Vilnius University Hospital Santaros Klinikos Children's Hospital Paediatrics Centre
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Not yet recruiting
        • Universitair Medisch Centrum Groningen
      • Multiple Locations, Netherlands
        • Not yet recruiting
        • Many Locations
      • Utrecht, Netherlands, 3584 CX
        • Not yet recruiting
        • University Medical Center Utrecht
  • Poland
      • Bialystok, Poland, 15-274
        • Not yet recruiting
        • Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa
      • Gdansk, Poland, 80-214
        • Not yet recruiting
        • Uniwersyteckie Centrum Kliniczne
      • Krakow, Poland, 30-663
        • Withdrawn
        • Uniwersytecki Szpital Dzieciecy w Krakowie
      • Lodz, Poland, 93-338
        • Recruiting
        • Instytut Centrum Zdrowia Matki Polki
      • Multiple Locations, Poland
        • Recruiting
        • Many Locations
      • Warszawa, Poland, 04-730
        • Recruiting
        • Instytut "Pomnik - Centrum Zdrowia Dziecka"
      • Wroclaw, Poland, 50-556
        • Withdrawn
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
  • Portugal
      • Braga, Portugal, 4710-243
        • Withdrawn
        • Centro Clinico Academico Braga | Braga, Portugal
      • Lisboa, Portugal, 1649-035
        • Withdrawn
        • CHULN - H. Sta.Maria (Centro de Investigacao Clinica)
      • Multiple Locations, Portugal
        • Not yet recruiting
        • Many Locations
      • Porto, Portugal, 4050-651
        • Not yet recruiting
        • Centro Hospitalar Universitario do Porto
  • Spain
      • Barcelona, Spain, 08023
        • Recruiting
        • Ciutat Sanitaria i Universitaria de la Vall d'Hebron
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Multiple Locations, Spain
        • Recruiting
        • Many Locations
      • Málaga, Spain, 29010
        • Not yet recruiting
        • Hospital Regional De Malaga
      • Sevilla, Spain, 41013
        • Recruiting
        • Virgen del Rocio University Hospital | Pediatric Nephrology Unit
    • Barcelona
      • Esplugues de LLobregat, Barcelona, Spain, 8950
        • Recruiting
        • Hospital de Sant Joan de Déu
  • Sweden
      • Lund, Sweden, 221 85
        • Not yet recruiting
        • Skane University Hospital
      • Multiple Locations, Sweden
        • Not yet recruiting
        • Many Locations
      • Stockholm, Sweden, 141 86
        • Not yet recruiting
        • Karolinska University Hospital
      • Uppsala, Sweden, 751 85
        • Not yet recruiting
        • Uppsala University Hospital
  • Switzerland
      • Multiple Locations, Switzerland
        • Recruiting
        • Many Locations
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4056
        • Not yet recruiting
        • Universitäts-Kinderspital UKBB
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Recruiting
        • Centre Hospitalier Universitaire Vaudois (CHUV)
  • Turkey
      • Ankara, Turkey, 06100
        • Not yet recruiting
        • Hacettepe Universitesi Tip Fakultesi
      • Ankara, Turkey, 06560
        • Not yet recruiting
        • Gazi Universitesi Tip Fakultesi
      • Ankara, Turkey, 06800
        • Not yet recruiting
        • Health Ministry Of Türkiye Republic Ankara Bilkent City Hospital
      • Ankara, Turkey, 06490
        • Recruiting
        • Baskent Universitesi Tip Fakultesi Hastanesi
      • Istanbul, Turkey, 34098
        • Recruiting
        • Istanbul Universitesi Cerrahpasa-Cocuk Nefrolojisi B. Dali
      • Istanbul, Turkey, 34899
        • Not yet recruiting
        • Marmara Uni. Tip Fakultesi Pendik Egitim ve Aras. Hastanesi
      • Istanbul, Turkey, 34093
        • Not yet recruiting
        • Istanbul Faculty of Medicine, Department of Internal Medicine, Department of Pediatrics
      • Multiple Locations, Turkey
        • Recruiting
        • Many Locations
  • United Kingdom
      • London, United Kingdom, WC1N 3JH
        • Recruiting
        • Great Ormond Street Hospital for Children
      • Manchester, United Kingdom, M13 9WL
        • Recruiting
        • Royal Manchester Children's Hospital
      • Multiple Locations, United Kingdom
        • Recruiting
        • Many Locations
      • Nottingham, United Kingdom, NG7 2UH
        • Not yet recruiting
        • Queens Medical Centre
    • Stratchclyde
      • Glasgow, Stratchclyde, United Kingdom, G3 8SJ
        • Recruiting
        • Royal Hospital for Children
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B16 8ET
        • Withdrawn
        • Birmingham Children's Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Not yet recruiting
        • Phoenix Children's Hospital | Main - Transplant Department
    • California
      • La Jolla, California, United States, 92093
        • Not yet recruiting
        • University of California San Diego (UCSD)
      • Palo Alto, California, United States, 94304
        • Not yet recruiting
        • Stanford Medicine
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Not yet recruiting
        • Children's Research Institute
    • Florida
      • Hollywood, Florida, United States, 33021
        • Not yet recruiting
        • South Broward Hosp. District dba Memorial Healthcare System
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Not yet recruiting
        • Emory University Hospital/Children's Healthcare of Atlanta (CHOA)
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Not yet recruiting
        • University of Iowa
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Not yet recruiting
        • Johns Hopkins Univ School Med|Johns Hopkins Hosp Dept Gyn/Ob
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Withdrawn
        • Boston Children's Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64108-9898
        • Not yet recruiting
        • Children's Mercy Hospital & Clinics
    • Ohio
      • Cincinnati, Ohio, United States, 45229-3039
        • Not yet recruiting
        • Cincinnati Children's Hospital and Medical Center
      • Cleveland, Ohio, United States, 14013
        • Not yet recruiting
        • Cleveland Clinic | Pediatric Nephrology
    • Oregon
      • Portland, Oregon, United States, 97239
        • Not yet recruiting
        • Oregon Health and Science Univ | Doernbecher Childrens Hosp
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Not yet recruiting
        • Children's Hospital of Philadelphia
    • Texas
      • San Antonio, Texas, United States, 78207
        • Not yet recruiting
        • Univ of Texas Health Science Center | Nephrology Res Dept
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Not yet recruiting
        • Primary Children's Hospital
    • Washington
      • Seattle, Washington, United States, 98105
        • Not yet recruiting
        • Seattle Children's Hospital

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.
Drug: Finerenone (Kerendia, BAY94-8862)
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

Bayer

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.

Helpful Links

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)

August 11, 2028

Study Completion (Estimated)

September 10, 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)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.

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