A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria (FIONA)

April 1, 2024 updated by: Bayer

A 6-month Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and PK/PD of an age-and Body Weight-adjusted Oral Finerenone Regimen, in Addition to an ACEI or ARB, for the Treatment of Children, 6 Months to <18 Years of Age, With Chronic Kidney Disease and Proteinuria

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 improve kidney function by helping the renin-angiotensin-aldosterone system (RAAS) to work normally. 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 stop the kidneys from working 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 more about whether finerenone added to either ACEI or ARB can help reduce the amount of protein in the participants' urine more than a placebo. A placebo looks like a treatment but does not have any medicine in it. Participants will also continue to receive their other medications.

To see how the treatment work, the doctors will take samples of the participants' urine to measure their protein levels before and during taking treatment and after their last treatment. In addition, blood samples will be taken to monitor kidney function, electrolytes and the amount of finerenone in the blood as well as for other tests.

This study will include children with CKD and proteinuria aged from 6 months up to less than 18 years. The participants will take:

either finerenone or the placebo, in addition to
either ACEI or ARB, whichever they take as part of their normal treatment

Two visits are required up to 104 days, to check whether a child can take part in the treatment phase of the study. If participants qualify for the treatment phase, they will then undergo treatment for about 180 days. During this time, they will visit the study site at least 7 times. During these visits, the participants 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 guardians answer
answer questions about how they are feeling, or have their parents or guardians answer
answer question about how they like the study medication, or have their parents or guardians 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)

219

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: For trial location information (Phone Menu Options '3' or '4')
Phone Number: (+)1-888-84 22937

Study Contact Backup

Name: Bayer Clinical Trials Contact
Phone Number: (+) 1-888-84 22937
Email: clinical-trials-contact@bayer.com

Study Locations

Argentina
- - Ciudad de Buenos Aires, Argentina, C1270AAN
    - Recruiting
    - Hospital General de Niños Pedro de Elizalde
  - San Luis, Argentina, D5700CGR
    - Recruiting
    - Centro de Rehabilitacion Cardiovascular | San Luis, Argentina
  - Santa Fe, Argentina, S3000
    - Recruiting
    - Clinica de Nefrologia, Urologia y Enfermedades Cardiovascualares - Santa Fe, Argentina
- Ciudad Auton. De Buenos Aires
  - Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1199ABB
    - Not yet recruiting
    - Hospital Italiano 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
- New South Wales
  - Westmead, New South Wales, Australia, 2145
    - Withdrawn
    - The Children's Hospital at Westmead
- Queensland
  - South Brisbane, Queensland, Australia, 4101
    - Recruiting
    - Queensland Children's Hospital
- Victoria
  - Clayton, Victoria, Australia, 3168
    - Recruiting
    - Monash Children's Hospital
  - Parkville, Victoria, Australia, 3052
    - Recruiting
    - Royal Children's Hospital Melbourne
Austria
- - Multiple Locations, Austria
    - Not yet recruiting
    - Many Locations
  - Salzburg, Austria, 5020
    - Recruiting
    - Uniklinikum Salzburg - Landeskrankenhaus
  - Wien, Austria, 1090
    - Recruiting
    - AKH Wien | Kinder & Jugendheilkunde, Kindernephrologie
- Oberösterreich
  - Linz, Oberösterreich, Austria, 4020
    - Recruiting
    - Kepler Universitätsklinikum Campus IV
- Steiermark
  - Graz, Steiermark, Austria, 8036
    - Recruiting
    - Medizinische Univ Graz | Kinder & Jugendheilkunde
Belgium
- - Bruxelles - Brussel, Belgium, 1200
    - Recruiting
    - CU Saint-Luc/UZ St-Luc
  - Bruxelles - Brussel, Belgium, 1020
    - 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
    - Not yet 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
    - Withdrawn
    - The Hospital for Sick Children (SickKids)
- Quebec
  - Montreal, Quebec, Canada, H3T 1C5
    - Recruiting
    - CHU Sainte-Justine
China
- - Multiple Locations, China
    - Suspended
    - Many Locations
Czechia
- - Multiple Locations, Czechia
    - Not yet recruiting
    - Many Locations
  - Praha 2, Czechia, 12808
    - Recruiting
    - Vseobecna fakultni nemocnice v Praze
  - Praha 5, Czechia, 150 06
    - Recruiting
    - Fakultní nemocnice v Motole
Denmark
- - Copenhagen, Denmark, 2100
    - Not yet recruiting
    - Rigshospitalet, Dept Pediatrics & Adelescent Med.
  - Multiple Locations, Denmark
    - Not yet 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
    - Not yet recruiting
    - Many Locations
  - Tampere, Finland, 33521
    - Recruiting
    - Pediatric Early Phase Trial Unit, Tampere University Hospita
  - Turku, Finland, 20520
    - Recruiting
    - Turun Yliopistollinen Keskussairaala
France
- - BORDEAUX cedex, France, 33076
    - Recruiting
    - Hôpital Pellegrin - Bordeaux
  - Bron, France, 69677
    - Recruiting
    - CHU de Lyon - Hôpital Femme Mère Enfant
  - Montpellier, France, 34059
    - Recruiting
    - Hôpital Arnaud de Villeneuve - Montpellier
  - Multiple Locations, France
    - Not yet recruiting
    - Many Locations
  - Paris, France, 75019
    - Recruiting
    - Hopital Robert Debre
  - Strasbourg, France, 67200
    - Recruiting
    - CHU STRASBOURG - Hôpital de Hautepierre
  - TOULOUSE Cedex 9, France, 31059
    - Recruiting
    - Hopital des Enfants
Germany
- - Berlin, Germany, 13353
    - Not yet recruiting
    - Charité / Pädiatrie
  - Hamburg, Germany, 20246
    - Recruiting
    - Universitätsklinikum Hamburg Eppendorf (UKE)
  - Multiple Locations, Germany
    - Not yet recruiting
    - Many Locations
- Baden-Württemberg
  - Heidelberg, Baden-Württemberg, Germany, 69120
    - Recruiting
    - Universitätsklinikum Heidelberg
- Bayern
  - Erlangen, Bayern, Germany, 91054
    - Withdrawn
    - Universitätsklinikum Erlangen
- Niedersachsen
  - Hannover, Niedersachsen, Germany, 30625
    - Recruiting
    - Medizinische Hochschule Hannover (MHH)
- Nordrhein-Westfalen
  - Bonn, Nordrhein-Westfalen, Germany, 53127
    - Recruiting
    - Kindernierenzentrum Bonn
  - Essen, Nordrhein-Westfalen, Germany, 45147
    - Recruiting
    - Universitätsklinikum Essen
  - Münster, Nordrhein-Westfalen, Germany, 48149
    - Recruiting
    - Universitätsklinikum Münster (UKM)
Greece
- - Athens, Greece
    - Recruiting
    - Children's Hospital of Athens P&A Kyriakou
  - Athens, Greece, 11527
    - Recruiting
    - AGIA SOFIA Children's Hospital
  - Crete, Greece, 71500
    - Recruiting
    - University General Hospital of Heraklion
  - Ioannina, Greece, 45500
    - Recruiting
    - Ioannina University General Hospital
  - Multiple Locations, Greece
    - Not yet recruiting
    - Many Locations
  - Thessaloniki, Greece
    - Recruiting
    - Hippokration General Hospital of Thessaloniki
Hungary
- - Budapest, Hungary, 1083
    - Recruiting
    - Semmelweis University
  - Debrecen, Hungary, 4032
    - Recruiting
    - Debreceni Egyetem Klinikai Kozpont
  - Multiple Locations, Hungary
    - Not yet recruiting
    - Many Locations
  - Pecs, Hungary, 7623
    - Recruiting
    - Pecsi Tudomanyegyetem Klinikai Kozpont
  - Szeged, Hungary, 6720
    - Recruiting
    - SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
Israel
- - Beer Sheva, Israel, 8410101
    - Recruiting
    - Soroka University Medical Center
  - Jerusalem, Israel, 9103102
    - Not yet recruiting
    - Wilf Children's Hospital Shaare Zedek Medical Center
  - Multiple Locations, Israel
    - Not yet 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
    - Recruiting
    - Dana-Dwek Children's Hospital
Italy
- - Multiple Locations, Italy
    - Not yet 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
    - Not yet 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
  - Seoul, Seoul Teugbyeolsi, Korea, Republic of, 08308
    - Recruiting
    - Korea University Guro Hospital
Lithuania
- - Kaunas, Lithuania, LT-50161
    - Recruiting
    - Hospital of LT University of Health Sciences Kaunas Clinics
  - Klaipeda, Lithuania, LT-92140
    - Withdrawn
    - Klaipeda Children's Hospital
  - Multiple Locations, Lithuania
    - Not yet recruiting
    - Many Locations
  - Vilnius, Lithuania, LT-08406
    - Recruiting
    - Vilnius University Hospital Santaros Klinikos Children's Hospital Paediatrics Centre
Netherlands
- - Groningen, Netherlands, 9713 GZ
    - Recruiting
    - Universitair Medisch Centrum Groningen
  - Multiple Locations, Netherlands
    - Not yet recruiting
    - Many Locations
  - Nijmegen, Netherlands, 6525 GA
    - Withdrawn
    - Universitair Medisch Centrum St. Radboud
  - Utrecht, Netherlands, 3584 CX
    - Recruiting
    - University Medical Center Utrecht
Poland
- - Bialystok, Poland, 15-274
    - 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
    - Not yet recruiting
    - Many Locations
  - Warszawa, Poland, 02-091
    - Withdrawn
    - Dzieciecy Szpital Kliniczny im. Jozefa Brudzinskiego
  - Warszawa, Poland, 04-730
    - Recruiting
    - Instytut "Pomnik - Centrum Zdrowia Dziecka"
  - Wroclaw, Poland, 50-556
    - Withdrawn
    - Uniwersytecki Szpital Kliniczny UM 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
    - Recruiting
    - Centro Hospitalar Universitario do Porto
Spain
- - Barcelona, Spain, 08023
    - Recruiting
    - Ciutat Sanitaria i Universitaria de la Vall d'Hebron
  - Madrid, Spain, 28041
    - Recruiting
    - H Univ. 12 de Octubre | Unidad Pediátrica Inv y EECC (UPIC)
  - Multiple Locations, Spain
    - Not yet recruiting
    - Many Locations
  - Málaga, Spain, 29010
    - 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
    - Recruiting
    - Skåne University Hospital
  - Multiple Locations, Sweden
    - Not yet recruiting
    - Many Locations
  - Stockholm, Sweden, 141 86
    - Recruiting
    - Karolinska University Hospital
  - Uppsala, Sweden, 751 85
    - Not yet recruiting
    - Uppsala University Hospital
Switzerland
- - Geneva, Switzerland, 1211
    - Recruiting
    - Hopital des Enfants HUG
  - Multiple Locations, Switzerland
    - Not yet 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
- - Adana, Turkey, 01790
    - Not yet recruiting
    - Cukurova Univ. Tip. Fak. Balcali Hastanesi
  - Ankara, Turkey, 06100
    - Recruiting
    - Hacettepe Universitesi Tip Fakultesi
  - Ankara, Turkey, 06560
    - Recruiting
    - Gazi Universitesi Tip Fakultesi
  - Ankara, Turkey, 06490
    - Recruiting
    - Baskent Universitesi Tip Fakultesi Hastanesi
  - Ankara, Turkey, 06800
    - Recruiting
    - Health Ministry Of Türkiye Republic Ankara Bilkent City Hospital
  - Istanbul, Turkey, 34098
    - Recruiting
    - Istanbul Universitesi Cerrahpasa-Cocuk Nefrolojisi B. Dali
  - Istanbul, Turkey, 34899
    - 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
    - Not yet recruiting
    - Many Locations
United Kingdom
- - Glasgow, United Kingdom, G51 4TF
    - Recruiting
    - Royal Hospital For Children
  - 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
    - Not yet recruiting
    - Many Locations
  - Nottingham, United Kingdom, NG7 2UH
    - Recruiting
    - Queens Medical Centre
- West Midlands
  - Birmingham, West Midlands, United Kingdom, B4 6NH
    - Withdrawn
    - Birmingham children's Hospital
United States
- Arizona
  - Phoenix, Arizona, United States, 85016
    - Not yet recruiting
    - Phoenix Children's Hospital | Main - Transplant Department
- California
  - Palo Alto, California, United States, 94304
    - Recruiting
    - Stanford Medicine
- Florida
  - Hollywood, Florida, United States, 33021
    - Not yet recruiting
    - South Broward Hosp. District dba Memorial Healthcare System
- 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
    - Recruiting
    - Cincinnati Children's Hospital and Medical Center
  - Cleveland, Ohio, United States, 14013
    - Not yet recruiting
    - Cleveland Clinic | Pediatric Nephrology
  - Columbus, Ohio, United States, 43205-2696
    - Withdrawn
    - Nationwide Children's Hospital
- 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

6 months to 17 years (Child)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Participants must be 6 months to <18 years old at the time when the informed consent/assent is signed
Participants must have a clinical diagnosis of chronic kidney disease (CKD) at screening which is defined as
- CKD stages 1-3 (eGFR ≥30 mL/min/1.73m^2) for children ≥1 year to <18 years of age or
- a serum creatinine ≤ 0.40 mg/dL for infants 6 months to < 1 year of age and
- severely increased proteinuria as defined by
  - Urinary protein-to-creatinine ratio (UPCR) of ≥ 0.50 g/g in participants ≥ 2 years with CKD stage 2 and 3 or
  - UPCR ≥ 1.0 g/g for patients < 2 years of age or ≥ 2 years of age and with CKD stage 1
Participants must have stable kidney function between screening and D0 defined as:
- no increase or decrease in eGFR ≥ 15% for children ≥1 year or
- no increase or decrease in creatinine ≥ 0.10 mg/dL for children <1 year
Treated with an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at optimized doses defined as maximally tolerable doses within the recommended dose range according to guidelines on blood pressure management, unchanged for at least 30 days prior to screening
K+ ≤5.0 mmol/L for children ≥2 years of age at both screening and D0, and ≤5.3 mmol/L for children <2 years of age at both screening and D0

Exclusion Criteria:

Planned urological surgery expected to influence renal function
Children with hemolytic uremic syndrome (HUS) diagnosed ≤6 months prior to screening
Patients with nephrotic syndrome receiving albumin infusions within the last 6 months prior to screening
Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame
Renal allograft in place
Bilateral renal artery stenosis
Acute kidney injury requiring dialysis within 6 months prior to screening
Systemic hypertension stage 2 in children ≥1 year of age defined according to guidelines on blood pressure management at screening or randomization
Systolic blood pressure (SBP) above 110 mmHg in infants 6 months to <1 year of age at screening or randomization
Systemic hypotension defined as a systolic blood pressure below the 5th percentile for age, sex and height at either screening or randomization but no lower than 80 mmHg (although for some participants the 5th percentile of SBP is < 80 mmHg they must be excluded if their SBP is <80 mmHg)
Participants with immune-mediated CKD using rituximab, cyclophosphamide, abatacept, or high-dose glucocorticoids, within <6 months prior to screening

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: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Finerenone (Kerendia, BAY94-8862) Participants will receive finerenone treatment.	Drug: Finerenone (Kerendia, BAY94-8862) Finerenone in different doses, treatment duration will be 180±7 days
Placebo Comparator: Placebo Participants will receive placebo to finerenone.	Drug: Placebo Placebo to finerenone, treatment duration will be 180±7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary protein-to-creatinine ratio (UPCR) reduction of at least 30% from baseline to day 180±7 Time Frame: From baseline to day 180±7	Proportion of participants at day 180±7 with a >=30% reduction in UPCR compared to baseline.	From baseline to day 180±7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number participants with treatment emergent adverse events (TEAEs） Time Frame: From the start of study intervention to last study intervention + 3 days (up to 190 days)	Below sub-categories will be considered: Serious Treatment Emergent Adverse Events (TEAEs) TEAEs and serious TEAEs leading to discontinuation of treatment Study drug related TEAEs and serious TEAEs TEAEs categorized by severity (mild, moderate, severe) TEAEs by maximum intensity Number of participants hospitalized with hyperkalemia, Number of participants discontinuing due to hyperkalemia, Number of participants with hospitalization for worsening of renal function Number of participants discontinuing due to worsening of renal function	From the start of study intervention to last study intervention + 3 days (up to 190 days)
Change in serum potassium levels from baseline to day 180±7 Time Frame: From baseline to day 180±7		From baseline to day 180±7
Change in serum creatinine from baseline to day 180±7 Time Frame: From baseline to day 180±7		From baseline to day 180±7
Change in eGFR from baseline to day 180±7 Time Frame: From baseline to day 180±7	Estimated glomerular filtration rate (eGFR)	From baseline to day 180±7
Change in systolic blood pressure from baseline to day 180±7 Time Frame: From baseline to day 180±7		From baseline to day 180±7
Mean reduction from baseline to day 180±7 in UPCR Time Frame: From baseline to day 180±7	Percent change from baseline to day 180±7 in UPCR will be calculated.	From baseline to day 180±7
Change in UACR from baseline to day 180±7 Time Frame: From baseline to day 180±7	Urinary albumin-to-creatinine ratio (UACR)	From baseline to day 180±7
Pharmacokinetics (PK) finerenone Cmax, md Time Frame: Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 180±7	Maximum observed finerenone concentration in plasma after multiple doses.	Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 180±7
Pharmacokinetics (PK) finerenone AUCτ,md Time Frame: Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 180±7	Area under the curve for finerenone concentration in plasma after multiple doses.	Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 180±7
Taste and texture questionnaire of the pediatric formulation Time Frame: On day 30±3 and day 180±7		On day 30±3 and day 180±7

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

Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

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)

March 28, 2022

Primary Completion (Estimated)

February 11, 2027

Study Completion (Estimated)

March 11, 2027

Study Registration Dates

First Submitted

January 7, 2022

First Submitted That Met QC Criteria

January 7, 2022

First Posted (Actual)

January 19, 2022

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

19920
2021-002071-19 (EudraCT Number)
2023-504884-17-00 (Other Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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

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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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Proteinuria

Clinical Trials on Finerenone (Kerendia, BAY94-8862)

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