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 1

Conditions: Chronic kidney diseaseProteinuria
MedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 20.1Level: PTClassification code 10037032Term: ProteinuriaSystem Organ Class: 10038359 - Renal and urinary disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2021-002071-19-BE

Lead Sponsor: Bayer AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 219

Inclusion Criteria

1. Participants must be 6 months to <18 years old at the time when the informed consent/assent is signed
2. 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
3. Participants must have stable kidney function between screening and D0 defined as:
a. no increase or decrease in eGFR = 15% for children =1 year or
b. no increase or decrease in creatinine = 0.10 mg/dL for children <1
year
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 management, unchanged for at least 30 days prior to screening
5. 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 219
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Planned urological surgery expected to influence renal function
2. Children with hemolytic uremic syndrome (HUS) diagnosed =6 months prior to screening
3. Patients with nephrotic syndrome receiving albumin infusions within the last 6 months prior to screening
4. Patients who are candidates for renal transplantation, i.e., a kidney transplantation scheduled within the study time frame
5. Renal allograft in place
6. Bilateral renal artery stenosis
7. Acute kidney injury requiring dialysis within 6 months prior to screening
8. Systemic hypertension stage 2 in children =1 year of age defined according to guidelines on blood pressure management at screening or randomization
9. Systolic blood pressure (SBP) above 110 mmHg in infants 6 months to <1 year of age at screening or randomization
10. 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)
11. 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to demonstrate that finerenone in addition to an ACEI or ARB is superior to placebo in reducing urine protein excretion ;Secondary Objective: Secondary objectives are:<br>To assess the safety profile of finerenone in addition to SoC in pediatric CKD patients compared to placebo<br>To further support the efficacy of finerenone in addition to SoC compared to placebo<br>To confirm the dose and systemic exposure of finerenone in CKD patients<br>To assess the acceptability and palatability of the age-appropriate pediatric formulation;Primary end point(s): Mean reduction from baseline to Month 6 in Urinary Protein-to-Creatinine Ratio<br>(Percent change from baseline to day 180±7 in UPCR);Timepoint(s) of evaluation of this end point: From baseline to day 180±7

Secondary Outcome Measures

Name	Time	Method

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