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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
EU CTIS ID: 2023-504885-50-00
What this study is testing
To demonstrate that finerenone in addition to an ACEI or ARB is safe when given long-term.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 (or local label / guidelines as applicable), 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
- Participant is able to receive enteral feeding (solid food, bottle or cup fed, feeding through nasogastric or gastric feeding tubes) with or without breastfeeding.
You likely can't join if
- Planned urological surgery expected to influence renal function
- 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 (S)AE related to the study intervention which led to permanent discontinuation of study intervention during the FIONA study
- Pregnant or breastfeeding or intention to become pregnant during the study
See the full eligibility criteria
Who can join
- 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 (or local label / guidelines as applicable), 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
- Participant is able to receive enteral feeding (solid food, bottle or cup fed, feeding through nasogastric or gastric feeding tubes) with or without breastfeeding.
What rules you out
- Planned urological surgery expected to influence renal function
- 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 (S)AE related to the study intervention which led to permanent discontinuation of study intervention during the FIONA study
- Pregnant or breastfeeding or intention to become pregnant during the study
- 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 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Malaysia
- India
- United States
- Argentina
- Brazil
- Turkey
- Taiwan
- Australia
- Korea, Republic of
- South Africa
- Mexico
- Israel
- United Kingdom
- Switzerland
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Malaysia; India; United States; Argentina; Brazil; Turkey and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.