A study to learn how well 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 by children with chronic kidney disease and proteinuria in addition to angiotensin-converting enzyme inhibitor or angiotensin receptor blocker

Phase 3

Recruiting

Conditions: Proteinuria
Chronic kidney disease

Registration Number: 2023-504884-17-00

Lead Sponsor: Bayer AG

Brief Summary: The primary objective is to demonstrate that finerenone in addition to an ACEI or ARB is superior to placebo in reducing urine protein excretion

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing, recruiting

Sex: Not specified

Target Recruitment: 222

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 a. CKD stages 1-3 (eGFR ≥30 mL/min/1.73m^2) for children ≥1 year to <18 years of age or b. a serum creatinine ≤ 0.40 mg/dL for infants 6 months to < 1 year of age and c. severely increased proteinuria as defined by i. Urinary protein-to-creatinine ratio (UPCR) of ≥ 0.50 g/g in participants ≥ 2 years with CKD stage 2 and 3 or ii. 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: a. For participants with a creatinine of > 0.8 mg/dL at screening: no increase or decrease in eGFR by ≥ 20% at D0 b. 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

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 (e.g., prednisolone ≥0.5 mg/kg/d), within <6 months prior to screening (low-dose glucocorticoids or a short course of glucocorticoids for, e.g., treatment of an asthma exacerbation are allowed)

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

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean reduction from baseline to Month 6 in Urinary Protein-toCreatinine Ratio (Percent change from baseline to day 180±7 in UPCR)		Mean reduction from baseline to Month 6 in Urinary Protein-toCreatinine Ratio (Percent change from baseline to day 180±7 in UPCR)

Secondary Outcome Measures

Name	Time	Method
Change in UACR from baseline to day 180±7		Change in UACR from baseline to day 180±7
PK (finerenone Cmax,md, AUCτ,md) based on total concentrations in plasma		PK (finerenone Cmax,md, AUCτ,md) based on total concentrations in plasma
Taste and texture of the pediatric formulation		Taste and texture of the pediatric formulation
Number of participants with a. AEs b. Serious TEAEs c. TEAEs and serious TEAEs leading to discontinuation of treatment d. Study drug related TEAEs and serious TEAEs e. TEAEs categorized by severity f. TEAEs by maximum intensity g. No. of participants hospitalized with hyperkalemia h. No. of participants discontinuing due to hyperkalemia i. No. of participants hospitalization for worsening of renal function j. No. of participants discontinuing due to worsening of renal function		Number of participants with a. AEs b. Serious TEAEs c. TEAEs and serious TEAEs leading to discontinuation of treatment d. Study drug related TEAEs and serious TEAEs e. TEAEs categorized by severity f. TEAEs by maximum intensity g. No. of participants hospitalized with hyperkalemia h. No. of participants discontinuing due to hyperkalemia i. No. of participants hospitalization for worsening of renal function j. No. of participants discontinuing due to worsening of renal function
Change in serum potassium levels, serum creatinine, eGFR and systolic blood pressure from baseline to day 180±7		Change in serum potassium levels, serum creatinine, eGFR and systolic blood pressure from baseline to day 180±7
Urinary Protein-to-Creatinine Ratio (UPCR) reduction of at least 30% from baseline to day 180±7 (Proportion of responders at the day 180±7 time point, where a responder is defined as a >=30% reduction in UPCR compared to baseline		Urinary Protein-to-Creatinine Ratio (UPCR) reduction of at least 30% from baseline to day 180±7 (Proportion of responders at the day 180±7 time point, where a responder is defined as a >=30% reduction in UPCR compared to baseline

Trial Locations

Locations (63): Centro Hospitalar Universitario De Santo Antonio E.P.E.
🇵🇹
Porto, Portugal
Athens General Children's Hospital Panagioti And Aglaia Kyriakou
🇬🇷
Athens, Greece
Ippokratio General Hospital Of Thessaloniki
🇬🇷
Thessaloniki, Greece
University General Hospital Of Ioannina
🇬🇷
Ioannina, Greece
University General Hospital Of Heraklion
🇬🇷
Heraklion, Greece
Nosokomeio Paidon I Agia Sofia
🇬🇷
Athens, Greece
Uppsala University Hospital
🇸🇪
Uppsala, Sweden
Region Skane Skanes Universitetssjukhus
🇸🇪
Lund, Sweden
Karolinska University Hospital
🇸🇪
Huddinge, Sweden
Odense University Hospital
🇩🇰
Odense C, Denmark
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Centro Hospitalar Universitario De Santo Antonio E.P.E.
🇵🇹Porto, Portugal
Alberto Caldas Afonso
Site contact
00351222077500
caldasafonso.cmin@chporto.min-saude.pt