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
- Conditions
- Chronic kidney diseaseProteinuriaMedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 20.1Level: PTClassification code 10037032Term: ProteinuriaSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2021-002071-19-GR
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 219
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
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 (lowdose 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
- Secondary Outcome Measures
Name Time Method