What is finerenone studying for children with chronic kidney disease and proteinuria?

This study is evaluating whether adding finerenone to standard treatment with ACE inhibitors or angiotensin receptor blockers can better reduce protein in urine for children with chronic kidney disease and proteinuria. Researchers want to understand if this combination helps control kidney function and related blood pressure issues. The study is sponsored by Bayer and aims to provide more treatment options for affected children.

Who may be eligible for this chronic kidney disease clinical trial?

Children from 6 months to under 18 years old with a diagnosis of chronic kidney disease and proteinuria may be eligible. They must be on stable doses of ACE inhibitors or angiotensin receptor blockers and have stable kidney function. Children with certain recent kidney surgeries, transplants, or other kidney conditions may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this chronic kidney disease clinical trial?

Study-related care, including the study drug or placebo and all trial visits, is provided at no cost. However, personal travel expenses to and from the study site may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel arrangements.

Actively Recruiting

Phase 3

Age: 6Months - 17Years

All Genders

ID05196035

Study of Finerenone Added to ACE Inhibitor or ARB for Children 6 Months to Under 18 Years with Chronic Kidney Disease and Proteinuria

Led by Bayer · Updated on 2026-06-22

219

Participants Needed

164

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating a new treatment approach for children with chronic kidney disease CKD and proteinuria, conditions that affect kidney function and cause protein leakage into the urine. The study focuses on whether adding a drug called finerenone to existing treatments with angiotensin-converting enzyme inhibitors ACEI or angiotensin receptor blockers ARB can better control kidney problems related to overactivity of a system that regulates blood pressure and fluid balance. This Phase 3 study aims to see if finerenone can reduce protein levels in the urine more effectively than a placebo. Participants in this trial will receive either finerenone or a placebo alongside their usual ACEI or ARB medication. The study treatment lasts about 180 days, with doses adjusted for age and body weight. Before starting treatment, children must pass screening visits to confirm eligibility. During treatment, participants will attend at least seven visits where various health checks, blood and urine tests, heart exams, and questionnaires about medication experience and side effects will be performed. Throughout the study, researchers will monitor kidney function, electrolyte levels, and how the body processes finerenone. They will also track any medical problems participants experience. After completing treatment, participants will have a follow-up visit about 30 days later to assess their health. The main measure of success is the change in the urinary protein-to-creatinine ratio from before treatment to about six months later, helping to understand the treatments impact on proteinuria.

CONDITIONS

Brief Title

A Study to Learn More About How Well the Study Treatment 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 With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria

Who Can Participate

Age: 6Months - 17Years

All Genders

Eligibility Criteria

You may qualify if you...

Children aged 6 months to less than 18 years at time of consent
Clinical diagnosis of chronic kidney disease (CKD) stages 1-3 for children 1 year or older, or serum creatinine ≤ 0.40 mg/dL for infants 6 months to under 1 year
Severely increased proteinuria defined by urinary protein-to-creatinine ratio (UPCR) ≥ 0.50 g/g for children 2 years or older with CKD stage 2 or 3, or UPCR ≥ 1.0 g/g for children under 2 years or with CKD stage 1
Stable kidney function between screening and day 0: no eGFR change ≥ 20% for creatinine > 0.8 mg/dL or no creatinine change ≥ 0.15 mg/dL for creatinine ≤ 0.8 mg/dL
Treatment with optimized doses of ACE inhibitor (ACEI) or angiotensin receptor blocker (ARB) unchanged for at least 30 days prior to screening
Potassium levels ≤ 5.0 mmol/L for children 2 years or older and ≤ 5.3 mmol/L for children under 2 years at screening and day 0

You will not qualify if you...

Planned urological surgery expected to affect kidney function
Hemolytic uremic syndrome diagnosed within 6 months prior to screening
Nephrotic syndrome with albumin infusions within 6 months prior to screening
Scheduled kidney transplantation during study period
Existing kidney transplant (renal allograft in place)
Bilateral renal artery stenosis
Acute kidney injury requiring dialysis within 6 months prior to screening
Stage 2 systemic hypertension in children 1 year or older at screening or randomization
Systolic blood pressure above 110 mmHg in infants 6 months to under 1 year at screening or randomization
Systemic hypotension defined as systolic blood pressure below the 5th percentile for age, sex, and height or below 80 mmHg at screening or randomization
Use of rituximab, cyclophosphamide, abatacept, or high-dose glucocorticoids for immune-mediated CKD within 6 months prior to screening

Research Team

Bayer Clinical Trials Contact

For trial location information (Phone Menu Options '3' or '4')

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