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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05457283




Registration number
NCT05457283
Ethics application status
Date submitted
11/07/2022
Date registered
13/07/2022
Date last updated
23/05/2024

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
N/A
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
10/09/2028
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 hospital [4] 0 0
Many Locations - Multiple Locations
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 postcode(s) [4] 0 0
- Multiple Locations
Recruitment outside Australia
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Nottingham

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

Ethics approval
Ethics application status

Summary
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 help
improve kidney function by reducing the activity of the renin-angiotensin-aldosterone system
(RAAS). The RAAS is a system that works with the kidneys to control blood pressure and the
balance of fluid and electrolytes in the blood. In people with CKD, the RAAS is often too
active, which can impair the ability of the kidneys to work properly and cause hypertension
and proteinuria. However, ACEI or ARB treatment alone does not work for all patients with CKD
as they only target the angiotensin part of the renin-angiotensin-aldosterone system.

The study treatment, finerenone, is expected to help control RAAS overactivation together
with an ACEI or ARB.

So, the researchers in this study want to learn more about whether finerenone given in
addition to either an ACEI or ARB can help their kidney function.

The main purpose of this study is to learn how safe the treatment is when used of finerenone
in addition to an ACEI or ARB in long-term.

To see how safe the treatment is, the study team will collect information on medical problems
which are also known as "treatment emergent adverse events" (TEAEs). And they will also
collect levels of an electrolyte called potassium in the blood by taking blood samples, and
measure blood pressure during the study.

The secondary purpose of this study is to learn how well long-term use of finerenone can
reduce the amount of protein in the participants' urine and benefit kidney function when
taken with standard of care.

To see how the treatment works, the study team will collect participants' urine samples to
assess urinary albumin-to-creatinine ratio (UACR) and urinary protein-to-creatinine ratio
(UPCR), which are important assessments for calculating the level of protein in the urine.
Researchers will also collect blood samples to analyze serum creatinine and calculate
estimated glomerular filtration rate (eGFR). A significant decline in eGFR indicates
worsening kidney function.

The study will include participants who had previously participated in FIONA study
(NCT05196035). The participants will be aged from 1 year up to 18 years.

The participants will be in the study for approximately 19 months. They will take study
treatment for up to 18 months and will be follow up for 1 month. During this period, at least
12 visits are planned for patients who newly start finerenone, and at least 8 visits for
patients who already received finerenone.

In the visit, the study team will:

- have their blood pressure, heart rate, temperature, height and weight measured

- have blood and urine samples taken

- have physical examinations

- have their heart examined by an electrocardiogram and echocardiography (a sonogram of
the heart)

- answer questions about their medication and whether they have any adverse events, or
have their parents or guardian's answer

- answer questions about how they are feeling, or have their parents or guardian's answer

- answer question about how they like the study medication, or have their parents or
guardian's answer The doctors will keep track of any adverse events. An adverse event is
any medical problem that a participant has during a study. Doctors keep track of all
adverse events that happen in studies, even if they do not think the adverse events
might be related to the study treatments.

The doctors will check the participants' health about 30 days after the participants take
their last treatment.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05457283
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05457283