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 <18 years of age, with chronic kidney disease and proteinuria

Phase 3

• Conditions: chronic kidney disease; chronic kidney disease with proteinuria; 10029149

• Registration Number: NL-OMON54048
• Lead Sponsor: Bayer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

- Participants must be 6 months to <18 years
- Participants must have a clinical diagnosis of CKD at screening
- Participants must have stable kidney function
- Treated with an ACEI or ARB at optimized doses

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
- Scheduled renal transplant within the next 6 months
- Renal allograft in place

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>See section 3 in protocol (V2.0)<br /><br>Number of participants with UPCR reduction of at least 30% from baseline to day<br /><br>180±7</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>See section 3 in protocol (V2.0)<br /><br>Number of participants with adverse events (AEs)<br /><br>Change in serum potassium levels from baseline to day 180±7<br /><br>Change in serum creatinine from baseline to day 180±7<br /><br>Change in eGFR from baseline to day 180±7 Change in systolic blood pressure<br /><br>from baseline to day 180±7<br /><br>Percent change in UPCR from baseline to day 180±7<br /><br>Change in UACR from baseline to day 180±7<br /><br>PK based on total concentrations in the plasma<br /><br>Taste and texture of the pediatric formula</p><br>