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-LT
- 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 at the time when the informed consent/assent is signed
2. Participants must have a clinical diagnosis of CKD at screening which is defined as
a. CKD stages I-III (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. UPCR of = 0.50 g/g in participants = 2 years with CKD stage II and III or
ii. UPCR = 1.0 g/g for patients < 2 years of age or = 2 years of age and with CKD stage I
3. Participants must have stable kidney function defined as no change in eGFR =± 15% for children =1 year to <18 years of age, or no change in serum creatinine = ±0.10 mg/dL for infants 6 months to <1 year of age between screening and D0
4. Treated with an ACEI or 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
6. Participants can be enrolled in the outpatient or inpatient setting
7. Study participants must have a body weight =4kg
8. Pregnancy testing as well as highly effective female contraception as appropriate for sexual maturity and activity and as required by local regulations are required for female participants
9. Participant has understood the study and if applicable, has signed an informed assent. The parent(s) or guardian(s) is capable of giving signed informed consent as described which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol
10. Participant is able to receive enteral feeding (solid food, bottle or cup fed, feeding through nasogastric or gastric feeding tubes) with or without breastfeeding
11. A legal guardian or primary caregiver must be available to help the study-site personnel ensure follow up; accompany the participant to the study site on each assessment day (e.g., able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures); consistently and consecutively be available to provide information on the participant; accurately and reliably dispense study intervention as directed.
12. A legal guardian or primary caregiver must be able to accurately maintain the child’s take-home record, including items of general health.
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 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 institutional guidelines on blood pressure management at screening or randomization
9. 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