This study has been transitioned to CTIS with ID 2023-504885-50-00 check the CTIS register for the current data. A study to learn more about how safe the study treatment finerenone is inlong-term use when taken with an ACE inhibitor or angiotensin…
ID
Source
Brief title
Condition
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main objective is to demonstrate that finerenone in addition to an
ACEI or ARB is safe when given long-term:
1. Number of participants with treatment emergent adverse events
(TEAEs)
2. Change in serum potassium levels from baseline to Day 540±7
3. Change in systolic blood pressure (SBP) from baseline to Day 540±7
Secondary outcome
The secondary objective is to assess the long-term treatment effects on
proteinuria and kidney function of finerenone in addition to standard of
care:
1. Change in urinary protein-to-creatinine ratio (UPCR) and urinary
albumin-to-creatinine ratio (UACR) from baseline to Day 540±7
2. Change in glomerular filtration rate (eGFR) from baseline to
Day 540±7
Background 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
reninangiotensin-
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.
Study objective
This study has been transitioned to CTIS with ID 2023-504885-50-00 check the CTIS register for the current data.
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
Study design
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
Intervention
BAY 94-8862 granules 3.4% Granules for oral suspension
BAY 94-8862 20 mg Coated tablet
BAY 94-8862 10 mg Coated tablet
Study burden and risks
There are 13 visits (screening/randomization and close out and regular visits
- the patient is asked 5 times to complete either 1 or 2 questionnaires.
- The patient is asked to submit urine 11 times
- The patient is asked to keep a handbook/diary from randomization
- The patient is not allowed to consume products containing grapefruit and St.
John's wort
- During each visit vital signs are checked
- weight and height are determined during approximately half of the visits
All visits druing the entire study study will take approximately 21 hours.
Measurements
Vital signs: pulse rate, no risks
vital signs blood pressure: no risk, possible discomfort around the arm due to
the blood presssure cuff
Body weight and height no risk
Blood draws: risks: pain, bruising, feeling faint or dizzy, infection
urine collection: no risk
ECG: risk: skin irritation
ECHO: no risk
BAY 94-8862 may have a therapeutic benefit, however this cannot be guaranteed.
patients are at risk of side effects.
Siriusdreef 36
Hoofddorp 2130AB
NL
Siriusdreef 36
Hoofddorp 2130AB
NL
Listed location countries
Age
Inclusion criteria
1. Participants must be >=1 year to 18 years of age, at the time of signing the
informed consent/assent. 2. 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. 3. 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 4. 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. 5. 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 6. Participant is able
to receive enteral feeding (solid food, bottle or cup fed, feeding through
nasogastric or gastric feeding tubes) with or without breastfeeding.
Exclusion criteria
1. Planned urological surgery expected to influence renal function 2. Patients
who are candidates for renal transplantation, i.e., a kidney transplantation
scheduled within the study time frame 3. Systemic hypertension Stage 2 defined
according to institutional guidelines on BP management at Visit 1. 4. 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. 5. Known
hypersensitivity to the study treatment (active substance or excipients) 6.
Severe hepatic insufficiency defined by e.g. Child-Pugh C or analogous scores.
7. Participants with immune-mediated CKD using rituximab, cyclophosphamide,
abatacept, or prolonged high-dose glucocorticoids (defined as >= 0.5 mg/kg/day
of prednisolone or equivalent) for more than 7 days. 8. 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) 9. Concomitant therapy with both ACEI and ARBs
together 10. Concomitant therapy with strong cytochrome P450 isoenzyme 3A4
(CYP3A4) inhibitors, moderate or strong CYP3A4 inducers 11. Previous assignment
to treatment during this study 12. Simultaneous participation in another
interventional clinical study (e.g., Phase 1 to 4 clinical studies). 13. Any
suspected (S)AE related to the study intervention which led to permanent
discontinuation of study intervention during the FIONA study 14. Pregnant or
breastfeeding or intention to become pregnant during the study
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2023-504885-50-00 |
| EudraCT | EUCTR2021-002905-89-NL |
| CCMO | NL81933.091.22 |