Clinical Trials List
2025-05-01 - 2027-11-30
Phase III
Recruiting6
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
-
Trial Applicant
BAYER TAIWAN COMPANY LTD.
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/04/10
Investigators and Locations
Co-Principal Investigator
- GWO-TSANN CHUANG Division of Pediatrics
- Shuenn Nan Chiu Division of Pediatrics
- 黃厚瑄 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 黃鈺珊醫師 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 盧姵真醫師 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Tablets
Tablets
Granules for suspension
Granules for suspension
Active Ingredient
Placebo
BAY 94-8862 micronized
Dosage Form
110
110
151
151
Dosage
20mg/ tablet
N/A
3.4%(W/W)
Endpoints
• UPCR decrease of at least 30% from base period to day 180±7
According to the agreed PIP, the key endpoint is:
• Percentage change in UPCR from base period to day 180±7
Inclution 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
The Estimated Number of Participants
-
Taiwan
14 participants
-
Global
438 participants
