Long-term safety of Finerenone for children with chronic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the long-term safety of Finerenone, a medication, when used alongside ACE inhibitors or angiotensin receptor blockers in children and young adults aged 1 to 18 years with chronic kidney disease (CKD) and proteinuria. The research aims to improve treatment outcomes for these patients by monitoring the effects of Finerenone over an 18-month period. Participants must have previously taken part in a related Phase 3 study and meet specific health criteria. The study focuses on managing CKD and associated hypertension through optimized medication regimens.

Why it matters

Who can join: the full rules

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.

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

Where it's running

• Hospital General de Ninos Ricardo Gutierrez | Pediatric Nephrology Department
  Buenos Aires, Argentina Recruiting
• Royal Children's Hospital Melbourne
  Parkville, Victoria, Australia Recruiting
• Hospital Pequeno Principe
  Curitiba, Paraná, Brazil Recruiting
• Hospital PUC-Campinas | Centro de Pesquisa Clínica Sao Lucas
  São Paulo, Brazil Recruiting
• Santa Casa de Misericórdia de Belo Horizonte
  São Paulo, Brazil Recruiting
• UMHAT Sveti Georgi
  Plovdiv, Plovdiv Province, Bulgaria Recruiting

+101 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Bayer Clinical Trials Contact
• Email: clinical-trials-contact@bayer.com
• Phone: 18888422937

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.