Back to resultsA 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)
Primary Purpose
Chronic Kidney Disease, Proteinuria
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Finerenone (Kerendia, BAY94-8862)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease
Eligibility Criteria
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 using rituximab, cyclophosphamide, abatacept, or intravenous glucocorticoids, within <6 months prior to screening for any reason
Sites / Locations
- Phoenix Children's Hospital | Main - Transplant Department
- Stanford Medicine
- South Broward Hosp. District dba Memorial Healthcare System
- University of Iowa
- Johns Hopkins Univ School Med|Johns Hopkins Hosp Dept Gyn/Ob
- Boston Children's Hospital
- Children's Mercy Hospital & Clinics
- Cincinnati Children's Hospital and Medical CenterRecruiting
- Cleveland Clinic | Pediatric Nephrology
- Nationwide Children's Hospital
- Oregon Health and Science Univ | Doernbecher Childrens Hosp
- Children's Hospital of Philadelphia
- Univ of Texas Health Science Center | Nephrology Res Dept
- Primary Children's Hospital
- Seattle Children's Hospital
- Hospital Italiano Buenos Aires
- Hospital de Niños "Ricardo Gutiérrez"
- Hospital General de Niños Pedro de Elizalde
- Centro de Rehabilitacion Cardiovascular | San Luis, Argentina
- Clinica de Nefrologia, Urologia y Enfermedades Cardiovascualares - Santa Fe, Argentina
- The Children's Hospital at Westmead
- Queensland Children's HospitalRecruiting
- Monash Children's Hospital
- Royal Children's Hospital MelbourneRecruiting
- Many Locations
- Kepler Universitätsklinikum Campus IVRecruiting
- Medizinische Univ Graz | Kinder & JugendheilkundeRecruiting
- Many Locations
- Uniklinikum Salzburg - LandeskrankenhausRecruiting
- AKH Wien | Kinder & Jugendheilkunde, KindernephrologieRecruiting
- Huderf / UkzkfRecruiting
- CU Saint-Luc/UZ St-LucRecruiting
- UZ GentRecruiting
- UZ Gasthuisberg - Pediatric NephrologyRecruiting
- CHC Montlégia - Pediatrics
- Many Locations
- Alberta Children's Hospital, University of Calgary
- The Hospital for Sick Children (SickKids)
- CHU Sainte-Justine
- Many Locations
- Many Locations
- Many Locations
- Vseobecna fakultni nemocnice v PrazeRecruiting
- Fakultni nemocnice v MotoleRecruiting
- Rigshospitalet, Dept Pediatrics & Adelescent Med.
- Many Locations
- Odense, HC AndersenRecruiting
- Aarhus Universitetshospital, SkejbyRecruiting
- HUS Uusi lastensairaalaRecruiting
- Many Locations
- Pediatric Early Phase Trial Unit, Tampere University HospitaRecruiting
- Turun yliopistollinen keskussairaalaRecruiting
- Hôpital Pellegrin - BordeauxRecruiting
- CHU de Lyon - Hopital Femme Mère EnfantRecruiting
- Hôpital Arnaud de Villeneuve - MontpellierRecruiting
- Many Locations
- Hopital Robert DebreRecruiting
- CHU STRASBOURG - Hôpital de HautepierreRecruiting
- Hôpital des EnfantsRecruiting
- Universitätsklinikum HeidelbergRecruiting
- Universitätsklinikum Erlangen
- Medizinische Hochschule Hannover (MHH)Recruiting
- Kindernierenzentrum BonnRecruiting
- Universitätsklinikum EssenRecruiting
- Universitätsklinikum Münster (UKM)Recruiting
- Charité / Pädiatrie
- Universitätsklinikum Hamburg Eppendorf (UKE)Recruiting
- Many Locations
- AGIA SOFIA Children's Hospital
- Children's Hospital of Athens P&A KyriakouRecruiting
- University General Hospital of HeraklionRecruiting
- Ioannina University General HospitalRecruiting
- Many Locations
- Hippokration General Hospital of ThessalonikiRecruiting
- Semmelweis UniversityRecruiting
- Debreceni Egyetem Klinikai KozpontRecruiting
- Many Locations
- Pecsi Tudomanyegyetem Klinikai KozpontRecruiting
- SZTE ÁOK Szent Györgyi Albert Klinikai KozpontRecruiting
- Soroka University Medical Center
- Wilf Children's Hospital Shaare Zedek Medical Center
- Many Locations
- Health Corporation of Galilee Medical CenterRecruiting
- Clalit Health Services Schneider Children's Medical CenterRecruiting
- Dana-Dwek Children's Hospital
- A.O.U. di Bologna Policlinico S.Orsola MalpighiRecruiting
- IRCCS Ospedale Pediatrico Bambino GesùRecruiting
- IRCCS Istituto Giannina GasliniRecruiting
- Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoRecruiting
- Many Locations
- Kyungpook National University HospitalRecruiting
- Seoul National University Bundang HospitalRecruiting
- Pusan National University Yangsan HospitalRecruiting
- Seoul National University HospitalRecruiting
- Korea University Guro Hospital
- Many Locations
- Hospital of LT University of Health Sciences Kaunas ClinicsRecruiting
- Klaipeda Children's Hospital
- Many Locations
- Vilnius University Hospital Santaros Klinikos Children's Hospital Paediatrics CentreRecruiting
- Universitair Medisch Centrum GroningenRecruiting
- Many Locations
- Universitair Medisch Centrum St. Radboud
- University Medical Center UtrechtRecruiting
- Uniwersytecki Dzieciecy Szpital Kliniczny im. L. ZamenhofaRecruiting
- Uniwersytecki Szpital Dzieciecy w Krakowie
- Instytut Centrum Zdrowia Matki PolkiRecruiting
- Many Locations
- Dzieciecy Szpital Kliniczny im. Jozefa Brudzinskiego
- Instytut "Pomnik - Centrum Zdrowia Dziecka"Recruiting
- Centro Clinico Academico - Braga
- CHULN - H. Sta.Maria (Centro de Investigacao Clinica)
- Many Locations
- Centro Hospitalar Universitario do PortoRecruiting
- Hospital de Sant Joan de DéuRecruiting
- Ciutat Sanitaria i Universitaria de la Vall d'HebronRecruiting
- H Univ. 12 de Octubre | Unidad Pediátrica Inv y EECC (UPIC)Recruiting
- Many Locations
- Hospital Regional de MálagaRecruiting
- H Univ. Virgen Rocío | Unidad Nefrología PediátricaRecruiting
- Skåne University HospitalRecruiting
- Many Locations
- Karolinska University HospitalRecruiting
- Uppsala University Hospital
- Universitäts-Kinderspital UKBB
- Centre Hospitalier Universitaire Vaudois (CHUV)Recruiting
- Hopital des Enfants HUG
- Many Locations
- Hacettepe Universitesi Tip FakultesiRecruiting
- Baskent Universitesi Tip Fakultesi HastanesiRecruiting
- Gazi Universitesi Tip FakultesiRecruiting
- Health Ministry Of Türkiye Republic Ankara Bilkent City HospitalRecruiting
- Istanbul Faculty of Medicine, Department of Internal Medicine, Department of Pediatrics
- Istanbul Universitesi Cerrahpasa-Cocuk Nefrolojisi B. DaliRecruiting
- Marmara Uni. Tip Fakultesi Pendik Egitim ve Aras. HastanesiRecruiting
- Many Locations
- Birmingham Children's Hospital
- Royal Hospital for ChildrenRecruiting
- Great Ormond Street Hospital for ChildrenRecruiting
- Royal Manchester Children's HospitalRecruiting
- Many Locations
- Queens Medical CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Finerenone (Kerendia, BAY94-8862)
Placebo
Arm Description
Participants will receive finerenone treatment.
Participants will receive placebo to finerenone.
Outcomes
Primary Outcome Measures
Urinary protein-to-creatinine ratio (UPCR) reduction of at least 30% from baseline to day 180±7
Proportion of participants at day 180±7 with a >=30% reduction in UPCR compared to baseline.
Secondary Outcome Measures
Number participants with treatment emergent adverse events (TEAEs）
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
Change in serum potassium levels from baseline to day 180±7
Change in serum creatinine from baseline to day 180±7
Change in eGFR from baseline to day 180±7
Estimated glomerular filtration rate (eGFR)
Change in systolic blood pressure from baseline to day 180±7
Mean reduction from baseline to day 180±7 in UPCR
Percent change from baseline to day 180±7 in UPCR will be calculated.
Change in UACR from baseline to day 180±7
Urinary albumin-to-creatinine ratio (UACR)
Pharmacokinetics (PK) finerenone Cmax, md
Maximum observed finerenone concentration in plasma after multiple doses.
Pharmacokinetics (PK) finerenone AUCτ,md
Area under the curve for finerenone concentration in plasma after multiple doses.
Taste and texture questionnaire of the pediatric formulation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05196035
Brief Title
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
Acronym
FIONA
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
February 11, 2027 (Anticipated)
Study Completion Date
March 11, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine.
The kidneys filter waste and fluid from the blood to form urine. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Proteinuria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
219 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Finerenone (Kerendia, BAY94-8862)
Arm Type
Experimental
Arm Description
Participants will receive finerenone treatment.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo to finerenone.
Intervention Type
Drug
Intervention Name(s)
Finerenone (Kerendia, BAY94-8862)
Intervention Description
Finerenone in different doses, treatment duration will be 180±7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to finerenone, treatment duration will be 180±7 days
Primary Outcome Measure Information:
Title
Urinary protein-to-creatinine ratio (UPCR) reduction of at least 30% from baseline to day 180±7
Description
Proportion of participants at day 180±7 with a >=30% reduction in UPCR compared to baseline.
Time Frame
From baseline to day 180±7
Secondary Outcome Measure Information:
Title
Number participants with treatment emergent adverse events (TEAEs）
Description
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
Time Frame
From the start of study intervention to last study intervention + 3 days (up to 190 days)
Title
Change in serum potassium levels from baseline to day 180±7
Time Frame
From baseline to day 180±7
Title
Change in serum creatinine from baseline to day 180±7
Time Frame
From baseline to day 180±7
Title
Change in eGFR from baseline to day 180±7
Description
Estimated glomerular filtration rate (eGFR)
Time Frame
From baseline to day 180±7
Title
Change in systolic blood pressure from baseline to day 180±7
Time Frame
From baseline to day 180±7
Title
Mean reduction from baseline to day 180±7 in UPCR
Description
Percent change from baseline to day 180±7 in UPCR will be calculated.
Time Frame
From baseline to day 180±7
Title
Change in UACR from baseline to day 180±7
Description
Urinary albumin-to-creatinine ratio (UACR)
Time Frame
From baseline to day 180±7
Title
Pharmacokinetics (PK) finerenone Cmax, md
Description
Maximum observed finerenone concentration in plasma after multiple doses.
Time Frame
Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 180±7
Title
Pharmacokinetics (PK) finerenone AUCτ,md
Description
Area under the curve for finerenone concentration in plasma after multiple doses.
Time Frame
Pre-dose, post-dose (1.5-5 hours after intake of intervention), up to day 180±7
Title
Taste and texture questionnaire of the pediatric formulation
Time Frame
On day 30±3 and day 180±7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bayer Clinical Trials Contact
Phone
(+) 1-888-84 22937
Email
clinical-trials-contact@bayer.com
First Name & Middle Initial & Last Name or Official Title & Degree
For trial location information (Phone Menu Options '3' or '4')
Phone
(+)1-888-84 22937
Facility Information:
Facility Name
Phoenix Children's Hospital | Main - Transplant Department
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Stanford Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
South Broward Hosp. District dba Memorial Healthcare System
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Johns Hopkins Univ School Med|Johns Hopkins Hosp Dept Gyn/Ob
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Children's Mercy Hospital & Clinics
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108-9898
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Cincinnati Children's Hospital and Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic | Pediatric Nephrology
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
14013
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205-2696
Country
United States
Individual Site Status
Withdrawn
Facility Name
Oregon Health and Science Univ | Doernbecher Childrens Hosp
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Withdrawn
Facility Name
Univ of Texas Health Science Center | Nephrology Res Dept
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Hospital Italiano Buenos Aires
City
Buenos Aires
State/Province
Ciudad Auton. De Buenos Aires
ZIP/Postal Code
C1199ABB
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Hospital de Niños "Ricardo Gutiérrez"
City
Buenos Aires
State/Province
Ciudad Auton. De Buenos Aires
ZIP/Postal Code
C1425EFD
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Hospital General de Niños Pedro de Elizalde
City
Ciudad de Buenos Aires
ZIP/Postal Code
C1270AAN
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Centro de Rehabilitacion Cardiovascular | San Luis, Argentina
City
San Luis
ZIP/Postal Code
D5700CGR
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Clinica de Nefrologia, Urologia y Enfermedades Cardiovascualares - Santa Fe, Argentina
City
Santa Fe
ZIP/Postal Code
S3000
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
The Children's Hospital at Westmead
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Queensland Children's Hospital
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Name
Monash Children's Hospital
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Royal Children's Hospital Melbourne
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Recruiting
Facility Name
Many Locations
City
Multiple Locations
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Kepler Universitätsklinikum Campus IV
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Medizinische Univ Graz | Kinder & Jugendheilkunde
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Name
Many Locations
City
Multiple Locations
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Uniklinikum Salzburg - Landeskrankenhaus
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Recruiting
Facility Name
AKH Wien | Kinder & Jugendheilkunde, Kindernephrologie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
Huderf / Ukzkf
City
Bruxelles - Brussel
ZIP/Postal Code
1020
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CU Saint-Luc/UZ St-Luc
City
Bruxelles - Brussel
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Gasthuisberg - Pediatric Nephrology
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHC Montlégia - Pediatrics
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Many Locations
City
Multiple Locations
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Alberta Children's Hospital, University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
The Hospital for Sick Children (SickKids)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Withdrawn
Facility Name
CHU Sainte-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Many Locations
City
Multiple Locations
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Many Locations
City
Multiple Locations
Country
China
Individual Site Status
Suspended
Facility Name
Many Locations
City
Multiple Locations
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Rigshospitalet, Dept Pediatrics & Adelescent Med.
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Name
Many Locations
City
Multiple Locations
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Name
Odense, HC Andersen
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Aarhus Universitetshospital, Skejby
City
Århus N
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Name
HUS Uusi lastensairaala
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Individual Site Status
Recruiting
Facility Name
Many Locations
City
Multiple Locations
Country
Finland
Individual Site Status
Not yet recruiting
Facility Name
Pediatric Early Phase Trial Unit, Tampere University Hospita
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Individual Site Status
Recruiting
Facility Name
Turun yliopistollinen keskussairaala
City
Turku
ZIP/Postal Code
20520
Country
Finland
Individual Site Status
Recruiting
Facility Name
Hôpital Pellegrin - Bordeaux
City
BORDEAUX cedex
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Lyon - Hopital Femme Mère Enfant
City
Bron
ZIP/Postal Code
69677
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Arnaud de Villeneuve - Montpellier
City
Montpellier
ZIP/Postal Code
34059
Country
France
Individual Site Status
Recruiting
Facility Name
Many Locations
City
Multiple Locations
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hopital Robert Debre
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Name
CHU STRASBOURG - Hôpital de Hautepierre
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital des Enfants
City
TOULOUSE Cedex 9
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Medizinische Hochschule Hannover (MHH)
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Name
Kindernierenzentrum Bonn
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Essen
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Münster (UKM)
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Charité / Pädiatrie
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitätsklinikum Hamburg Eppendorf (UKE)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Name
Many Locations
City
Multiple Locations
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
AGIA SOFIA Children's Hospital
City
Athens
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
Children's Hospital of Athens P&A Kyriakou
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Name
University General Hospital of Heraklion
City
Crete
ZIP/Postal Code
71500
Country
Greece
Individual Site Status
Recruiting
Facility Name
Ioannina University General Hospital
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
Individual Site Status
Recruiting
Facility Name
Many Locations
City
Multiple Locations
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
Hippokration General Hospital of Thessaloniki
City
Thessaloniki
Country
Greece
Individual Site Status
Recruiting
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Many Locations
City
Multiple Locations
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Pecsi Tudomanyegyetem Klinikai Kozpont
City
Pecs
ZIP/Postal Code
7623
Country
Hungary
Individual Site Status
Recruiting
Facility Name
SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Soroka University Medical Center
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Wilf Children's Hospital Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Many Locations
City
Multiple Locations
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Health Corporation of Galilee Medical Center
City
Nahariya
ZIP/Postal Code
2210001
Country
Israel
Individual Site Status
Recruiting
Facility Name
Clalit Health Services Schneider Children's Medical Center
City
Petach Tikva
ZIP/Postal Code
4920235
Country
Israel
Individual Site Status
Recruiting
Facility Name
Dana-Dwek Children's Hospital
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
A.O.U. di Bologna Policlinico S.Orsola Malpighi
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Ospedale Pediatrico Bambino Gesù
City
Roma
State/Province
Lazio
ZIP/Postal Code
00165
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Istituto Giannina Gaslini
City
Genova
State/Province
Liguria
ZIP/Postal Code
16147
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Many Locations
City
Multiple Locations
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Kyungpook National University Hospital
City
Daegu
State/Province
Daegu Gwang''yeogsi
ZIP/Postal Code
41944
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggido
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan-si
State/Province
Gyeongsangnamdo
ZIP/Postal Code
50612
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea University Guro Hospital
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Many Locations
City
Multiple Locations
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Hospital of LT University of Health Sciences Kaunas Clinics
City
Kaunas
ZIP/Postal Code
LT-50161
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Klaipeda Children's Hospital
City
Klaipeda
ZIP/Postal Code
LT-92140
Country
Lithuania
Individual Site Status
Withdrawn
Facility Name
Many Locations
City
Multiple Locations
Country
Lithuania
Individual Site Status
Not yet recruiting
Facility Name
Vilnius University Hospital Santaros Klinikos Children's Hospital Paediatrics Centre
City
Vilnius
ZIP/Postal Code
LT-08406
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Many Locations
City
Multiple Locations
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Universitair Medisch Centrum St. Radboud
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Individual Site Status
Withdrawn
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa
City
Bialystok
ZIP/Postal Code
15-274
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Dzieciecy w Krakowie
City
Krakow
ZIP/Postal Code
30-663
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Instytut Centrum Zdrowia Matki Polki
City
Lodz
ZIP/Postal Code
93-338
Country
Poland
Individual Site Status
Recruiting
Facility Name
Many Locations
City
Multiple Locations
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Dzieciecy Szpital Kliniczny im. Jozefa Brudzinskiego
City
Warszawa
ZIP/Postal Code
02-091
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Instytut "Pomnik - Centrum Zdrowia Dziecka"
City
Warszawa
ZIP/Postal Code
04-730
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centro Clinico Academico - Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Individual Site Status
Withdrawn
Facility Name
CHULN - H. Sta.Maria (Centro de Investigacao Clinica)
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Withdrawn
Facility Name
Many Locations
City
Multiple Locations
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Centro Hospitalar Universitario do Porto
City
Porto
ZIP/Postal Code
4050-651
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital de Sant Joan de Déu
City
Esplugues de LLobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Recruiting
Facility Name
Ciutat Sanitaria i Universitaria de la Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Individual Site Status
Recruiting
Facility Name
H Univ. 12 de Octubre | Unidad Pediátrica Inv y EECC (UPIC)
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Many Locations
City
Multiple Locations
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Regional de Málaga
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
H Univ. Virgen Rocío | Unidad Nefrología Pediátrica
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Skåne University Hospital
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Many Locations
City
Multiple Locations
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
Universitäts-Kinderspital UKBB
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4056
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
Centre Hospitalier Universitaire Vaudois (CHUV)
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Hopital des Enfants HUG
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
Many Locations
City
Multiple Locations
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
Hacettepe Universitesi Tip Fakultesi
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Baskent Universitesi Tip Fakultesi Hastanesi
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Gazi Universitesi Tip Fakultesi
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Health Ministry Of Türkiye Republic Ankara Bilkent City Hospital
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Istanbul Faculty of Medicine, Department of Internal Medicine, Department of Pediatrics
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Istanbul Universitesi Cerrahpasa-Cocuk Nefrolojisi B. Dali
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Marmara Uni. Tip Fakultesi Pendik Egitim ve Aras. Hastanesi
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Many Locations
City
Multiple Locations
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Birmingham Children's Hospital
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Royal Hospital for Children
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Great Ormond Street Hospital for Children
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Manchester Children's Hospital
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Many Locations
City
Multiple Locations
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Queens Medical Centre
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Links:
URL
https://clinicaltrials.bayer.com/
Description
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.
Learn more about this trial
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
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