Short title: 19920 FIONA Finerenone for the treatment of children with chronic nephropathy and proteinuria

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Korea, Republic of, Lithuania, Malaysia, Mexico, Netherlands, Poland, Portugal, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States (ICTRP)

ICTRP Trial ID
NCT05196035 (ICTRP)

Official title (approved by ethics committee)
A 6-month multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and PK/PD of an age-and body weight-adjusted oral finerenone regimen, in addition to an ACEI or ARB, for the treatment of children, 6 months to <18 years of age, with chronic kidney disease and proteinuria (BASEC)

Academic title
A 6-month Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and PK/PD of an age-and Body Weight-adjusted Oral Finerenone Regimen, in Addition to an ACEI or ARB, for the Treatment of Children, 6 Months to <18 Years of Age, With Chronic Kidney Disease and Proteinuria (ICTRP)

Public title
A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria (ICTRP)

Disease under investigation
Chronic Kidney DiseaseProteinuria (ICTRP)

Intervention under investigation
Drug: Finerenone (Kerendia, BAY94-8862)Drug: Placebo (ICTRP)

Type of trial
Interventional (ICTRP)

Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)

Inclusion/Exclusion criteria
Inclusion Criteria:

- Participants must be 6 months to <18 years old at the time when the informed
consent/assent is signed

- Participants must have a clinical diagnosis of chronic kidney disease (CKD) at
screening which is defined as

- CKD stages 1-3 (eGFR =30 mL/min/1.73m^2) for children =1 year to <18 years of
age or

- a serum creatinine = 0.40 mg/dL for infants 6 months to < 1 year of age and

- severely increased proteinuria as defined by

- Urinary protein-to-creatinine ratio (UPCR) of = 0.50 g/g in participants =
2 years with CKD stage 2 and 3 or

- UPCR = 1.0 g/g for patients < 2 years of age or = 2 years of age and with
CKD stage 1

- Participants must have stable kidney function between screening and D0 defined as:

- For participants with a creatinine of > 0.8 mg/dL at screening: no increase or
decrease in eGFR by = 20% at D0

- For participants with a creatinine of = 0.8 mg/dL at screening: no increase or
decrease in creatinine = 0.15 mg/dL at D0.

- 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
management, unchanged for at least 30 days prior to screening

- K+ =5.0 mmol/L for children =2 years of age at both screening and D0, and =5.3
mmol/L for children <2 years of age at both screening and D0

Exclusion Criteria:

- Planned urological surgery expected to influence renal function

- Children with hemolytic uremic syndrome (HUS) diagnosed =6 months prior to screening

- Patients with nephrotic syndrome receiving albumin infusions within the last 6
months prior to screening

- Patients who are candidates for renal transplantation, i.e., a kidney
transplantation scheduled within the study time frame

- Renal allograft in place

- Bilateral renal artery stenosis

- Acute kidney injury requiring dialysis within 6 months prior to screening

- Systemic hypertension stage 2 in children =1 year of age defined according to
guidelines on blood pressure management at screening or randomization

- Systolic blood pressure (SBP) above 110 mmHg in infants 6 months to <1 year of age
at screening or randomization

- Systemic hypotension defined as a systolic blood pressure below the 5th percentile
for age, sex and height at either screening or randomization but no lower than 80
mmHg (although for some participants the 5th percentile of SBP is < 80 mmHg they
must be excluded if their SBP is <80 mmHg)

- Participants with immune-mediated CKD using rituximab, cyclophosphamide, abatacept,
or high-dose glucocorticoids, within <6 months prior to screening (ICTRP)

not available

Primary and secondary end points
Urinary protein-to-creatinine ratio (UPCR) reduction of at least 30% from baseline to day 180�7 (ICTRP)

Number participants with treatment emergent adverse events (TEAEs);Change in serum potassium levels from baseline to day 180�7;Change in serum creatinine from baseline to day 180�7;Change in eGFR from baseline to day 180�7;Change in systolic blood pressure from baseline to day 180�7;Mean reduction from baseline to day 180�7 in UPCR;Change in UACR from baseline to day 180�7;Pharmacokinetics (PK) finerenone Cmax, md;Pharmacokinetics (PK) finerenone AUCt,md;Taste and texture questionnaire of the pediatric formulation (ICTRP)

Registration date
not available

Incorporation of the first participant
not available

Secondary sponsors
not available

Additional contacts
Bayer Clinical Trials Contact, clinical-trials-contact@bayer.com, (+) 1-888-84 22937 (ICTRP)

Secondary trial IDs
2023-504884-17-00, 2021-002071-19, 19920 (ICTRP)

Results-Individual Participant Data (IPD)
not available

Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT05196035 (ICTRP)