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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05457283




Registration number
NCT05457283
Ethics application status
Date submitted
11/07/2022
Date registered
13/07/2022

Titles & IDs
Public title
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
Scientific title
An 18-month, Open-label, Single-arm Safety Extension Study of an age-and Bodyweight-adjusted Oral Finerenone Regimen, in Addition to an ACEI or ARB, for the Treatment of Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria
Secondary ID [1] 0 0
2023-504885-50-00
Secondary ID [2] 0 0
20186
Universal Trial Number (UTN)
Trial acronym
FIONA OLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 0 0
Proteinuria 0 0
Children 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Finerenone (Kerendia, BAY94-8862)

Experimental: Finerenone Open-Label safety Extension - Participants will receive finerenone treatment.


Treatment: Drugs: Finerenone (Kerendia, BAY94-8862)
Finerenone in different doses, treatment duration will be 540 ±7 days.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment emergent adverse event (TEAEs)
Timepoint [1] 0 0
Up to 550 days
Primary outcome [2] 0 0
Change in serum potassium levels from baseline to Day 540±7
Timepoint [2] 0 0
Up to 547 days
Primary outcome [3] 0 0
Change in systolic blood pressure (SBP) from baseline to Day 540±7
Timepoint [3] 0 0
Up to 547 days
Secondary outcome [1] 0 0
Change in urinary protein-to-creatinine ratio (UPCR) from baseline to Day 540±7
Timepoint [1] 0 0
Up to 547 days
Secondary outcome [2] 0 0
Change in urinary albumin-to-creatinine ratio (UACR) from baseline to Day 540±7
Timepoint [2] 0 0
Up to 547 days
Secondary outcome [3] 0 0
Change in estimated glomerular filtration rate (eGFR) from baseline to Day 540±7
Timepoint [3] 0 0
Up to 547 days

Eligibility
Key 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.
Minimum age
1 Year
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2028
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [2] 0 0
Monash Children's Hospital - Clayton
Recruitment hospital [3] 0 0
Royal Children's Hospital Melbourne - Parkville
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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United States of America
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District of Columbia
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United States of America
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Florida
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Georgia
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United States of America
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Iowa
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Maryland
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Massachusetts
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Missouri
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Ohio
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Oregon
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Pennsylvania
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Texas
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Utah
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Washington
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Argentina
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Buenos Aires
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Argentina
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Ciudad Auton. De Buenos Aires
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Argentina
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Provincia De San Luis
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Argentina
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Provincia De Santa Fe
Country [20] 0 0
Argentina
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Multiple Locations
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Austria
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Oberösterreich
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Austria
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Steiermark
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Austria
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Multiple Locations
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Austria
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Salzburg
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Austria
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Wien
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Belgium
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Bruxelles - Brussel
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Belgium
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Gent
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Belgium
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Leuven
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Belgium
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Liège
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Belgium
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Multiple Locations
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Canada
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Alberta
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Canada
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Ontario
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Canada
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Quebec
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Czechia
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Czechia
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Praha 2
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Czechia
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Praha 5
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Denmark
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Copenhagen
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Denmark
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Denmark
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Odense C
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Denmark
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Århus N
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Finland
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Helsinki
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Finland
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Multiple Locations
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Finland
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Tampere
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Finland
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Turku
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France
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BORDEAUX cedex
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France
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Bron
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Montpellier
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France
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France
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Paris
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France
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Strasbourg
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France
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TOULOUSE Cedex 9
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Germany
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Baden-Württemberg
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Germany
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Bayern
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Berlin
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Germany
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Hamburg
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Germany
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Multiple Locations
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Greece
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Athens
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Greece
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Heraklion
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Greece
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Ioannina
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Greece
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Multiple Locations
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Greece
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Thessaloniki
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Multiple Locations
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Hungary
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Pecs
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Hungary
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Szeged
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Israel
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Beer Sheva
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Jerusalem
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Israel
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Israel
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Nahariya
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Israel
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Petach Tikva
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Israel
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Tel Aviv
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Italy
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Emilia-Romagna
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Italy
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Lazio
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Italy
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Liguria
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Italy
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Lombardia
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Italy
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Firenze
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Italy
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Italy
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Torino
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Korea, Republic of
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Daegu Gwang''yeogsi
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Gyeonggido
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Gyeongsangnamdo
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Korea, Republic of
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Seoul Teugbyeolsi
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Korea, Republic of
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Korea, Republic of
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Seoul
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Lithuania
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Kaunas
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Lithuania
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Klaipeda
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Lithuania
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Vilnius
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Netherlands
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Groningen
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Netherlands
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Utrecht
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Poland
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Bialystok
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Gdansk
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Krakow
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Lodz
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Poland
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Warszawa
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Poland
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Wroclaw
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Portugal
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Braga
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Portugal
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Coimbra
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Lisboa
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Portugal
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Porto
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Spain
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Málaga
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Spain
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Sevilla
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Sweden
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Lund
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Sweden
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Sweden
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Stockholm
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Sweden
State/province [114] 0 0
Uppsala
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Switzerland
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Basel-Stadt
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Switzerland
State/province [116] 0 0
Vaud
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Switzerland
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Geneva
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Switzerland
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Multiple Locations
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Turkey
State/province [119] 0 0
Ankara
Country [120] 0 0
Turkey
State/province [120] 0 0
Istanbul
Country [121] 0 0
Turkey
State/province [121] 0 0
Multiple Locations
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United Kingdom
State/province [122] 0 0
Stratchclyde
Country [123] 0 0
United Kingdom
State/province [123] 0 0
West Midlands
Country [124] 0 0
United Kingdom
State/province [124] 0 0
London
Country [125] 0 0
United Kingdom
State/province [125] 0 0
Manchester
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Multiple Locations
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bayer Clinical Trials Contact
Address 0 0
Country 0 0
Phone 0 0
(+)1-888-84 22937
Fax 0 0
Email 0 0
clinical-trials-contact@bayer.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
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.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05457283