Actively Recruiting
An 18-month Open-label Study of Oral Finerenone with ACE Inhibitor or Angiotensin Receptor Blocker in Children 1 to 18 Years with Chronic Kidney Disease and Proteinuria
Led by Bayer · Updated on 2026-06-02
100
Participants Needed
179
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating treatments for children aged 1 to 18 years with chronic kidney disease CKD and proteinuria, conditions where the kidneys do not function properly and leak protein into the urine. CKD can cause complications like high blood pressure, and treatments currently include ACE inhibitors ACEI or angiotensin receptor blockers ARB that help control blood pressure and protein levels. This study focuses on evaluating the safety and effects of adding finerenone to these standard treatments, aiming to better manage the overactive kidney system involved in these conditions. Participants will receive finerenone orally, adjusted by age and body weight, alongside their existing ACEI or ARB treatment. The study lasts about 19 months, with up to 18 months of finerenone treatment and a one-month follow-up. During this time, children who are new to finerenone will have at least 12 visits, while those already on finerenone will have at least 8 visits. At these visits, various health checks and sample collections will occur to monitor safety and kidney function. Throughout the study, researchers will regularly measure blood pressure, heart rate, temperature, height, and weight, and collect blood and urine samples to assess kidney function and protein levels. They will also perform heart tests using electrocardiograms and echocardiography. Participants and their guardians will answer questions about medication use and any medical problems experienced. Safety will be closely monitored by tracking any adverse events during the study and a health check will be done about 30 days after treatment ends.
CONDITIONS
Brief Title
A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 1 to 18 years at the time of consent
- Prior participation in the Phase 3 finerenone FIONA study without permanent treatment discontinuation
- Clinical diagnosis of chronic kidney disease stages 1 to 3 (eGFR 60 mL/min/1.73m8)
- Treated with ACE inhibitor or angiotensin receptor blocker at stable, maximally tolerated doses for at least 30 days before Visit 1
- Potassium levels 5.0 mmol/L for children 6 years, and 5.3 mmol/L for children under 2 years, at both FIONA end of treatment and Visit 1
- Capable of giving informed consent if of legal age
- Able to receive enteral feeding by any method, including breastfeeding
You will not qualify if you...
- Planned urological surgery expected to affect kidney function
- Scheduled kidney transplant during study period
- Stage 2 systemic hypertension at Visit 1
- Symptomatic or low blood pressure below defined age and height percentiles at Visit 1
- Known allergy to finerenone or its ingredients
- Severe liver failure (e.g., Child-Pugh C)
- Use of rituximab, cyclophosphamide, abatacept, or intravenous glucocorticoids
- Use of mineralocorticoid receptor antagonists, renin inhibitors, SGLT2 inhibitors, sacubitril/valsartan, or potassium-sparing diuretics
- Concurrent use of both ACE inhibitors and angiotensin receptor blockers
- Treatment with strong CYP3A4 inhibitors or inducers
- Previous assignment to treatment in this study
- Participation in another interventional clinical trial
- Serious adverse event during FIONA study leading to treatment stop
- Pregnancy, breastfeeding, or intent to become pregnant during the study
Research Team
B
Bayer Clinical Trials Contact
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