A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use Wh
Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine. The kidneys filter waste and fluid from the blood to form urine. In children with CKD, the kidney´s f
| Condition(s) | Chronic Kidney Disease, Proteinuria, Children |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine. The kidneys filter waste and fluid from the blood to form urine. In children with CKD, the kidney´s filters do not work as well as they should. This can lead to accumulation of waste and fluid in the body and proteinuria. CKD can lead to other medical problems, such as high blood pressure, also known as hypertension. Vice versa, hypertension and proteinuria can also contribute to worsening of CKD. Therefore, the treatment of CKD aims to control blood pressure and proteinuria. There are treatments available for doctors to prescribe to children with CKD and hypertension and/or |
| Who can participate | Inclusion Criteria: * Participants must be ≥1 year to 18 years of age, at the time of signing the informed consent/assent. * Prior participation in the finerenone Phase 3 study FIONA (19920) and not permanently discontinued from treatment by the end of treatment (EoT) visit in FIONA. * Participants must have a clinical diagnosis of chronic kidney disease (CKD) at Visit 1 which is defined as * CKD stages 1-3 (estimated glomerular filtration rate \[eGFR\] ≥30 mL/min/1.73m\^2) for children ≥1 year to \<19 years of age at FIONA EoT and at Visit 1 * 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 (BP) management, |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Lead sponsor | Bayer |
| Locations | Phoenix, Arizona, United States; Los Angeles, California, United States; Palo Alto, California, United States; San Diego, California, United States; Washington D.C., District of Columbia, United States; Hollywood, Florida, United States (+173 more sites) |
| Start date | 2022-11-08 |
| NCT ID | NCT05457283 |
| Official listing | https://clinicaltrials.gov/study/NCT05457283 |