ArticleTrials2024
Investigating the use of finerenone in children with chronic kidney disease and proteinuria: design of the FIONA and open-label extension studies.
Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 3 registered trials, which are not on this map. Cited by 15 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate the Safety and Efficacy of Finerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate Efficacy and Safety of Finerenone on the Reduction of Cardiovascular Morbidity and Mortality in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease in Addition to Standard of Care.
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
Who cites it
15 citing papers in PubMed, 15 citations in OpenAlex.
- New therapeutic hope for rare podocytopathies.Pediatric nephrology (Berlin, Germany) · 2026Review
- Characterizing children with chronic kidney disease and severe proteinuria in the United States: a retrospective analysis using electronic health records.Pediatric nephrology (Berlin, Germany) · 2026Article
- GLP-1 receptor agonists-a potential therapy for chronic kidney disease?Clinical science (London, England : 1979) · 2026Review
- The use of albuminuria and proteinuria for regulatory clinical decision making: a perspective from European regulators.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2026Article
- Intersection of Pediatric Hypertension and Cardiovascular-Kidney-Metabolic Disease.Current hypertension reports · 2026Review
- Mineralocorticoid receptor antagonists: Efficacy and safety in chronic kidney disease.Diabetes, obesity & metabolism · 2026Review
- Finerenone in kidney transplantation: an underinvestigated agent: review of available evidence, existing gaps, and future directions.Clinical transplantation and research · 2026Review
- Article
- Preserving nephron number in children after preterm birth: a top priority.Pediatric nephrology (Berlin, Germany) · 2026Article
- Clinical Trial End Points for Childhood CKD.Journal of the American Society of Nephrology : JASN · 2025Article
- Drug Development in Pediatric Chronic Kidney Disease: A Review of Promising Treatments, Old Challenges, and New Strategies.Paediatric drugs · 2025Review
- Real-world evidence of lisinopril in pediatric hypertension and nephroprotective management: a 10-year cohort study.Pediatric nephrology (Berlin, Germany) · 2025Article
- Co-occurrence of Charcot-Marie-Tooth disease type 1 and glomerulosclerosis in a patient with a de novo INF2 variant.BMC nephrology · 2024Article
- Finerenone: A Third-Generation MRA and Its Impact on Cardiovascular Health-Insights from Randomized Controlled Trials.Journal of clinical medicine · 2024Review
- Novel OFD1 Mutation Results in Unusually Early-Onset Polycystic Kidney Disease.Case reports in nephrology and dialysisArticle
Corrections and comments
- Erratum issued
Authors and funding
13 authors at 10 institutions in 7 countries.
Funding
Abstract
introductionProteinuria is a modifiable risk factor for chronic kidney disease (CKD) progression in children. Finerenone, a selective, non-steroidal, mineralocorticoid receptor antagonist (MRA) has been approved to treat adults with CKD associated with type 2 diabetes mellitus (T2DM) following results from the phase III clinical trials FIDELIO-DKD (NCT02540993) and FIGARO-DKD (NCT02545049). In a pre-specified pooled analysis of both studies (N = 13,026), finerenone was shown to have an acceptable safety profile and was efficacious in decreasing the risk of adverse kidney and cardiovascular outcomes and of proteinuria.
objectiveFIONA and the associated open-label extension (OLE) study aim to demonstrate that combining finerenone with an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) is safe, well-tolerated, and effective in sustainably reducing urinary protein excretion in children with CKD and proteinuria.
designFIONA (NCT05196035; Eudra-CT: 2021-002071-19) is a randomized (2:1), double-blind, placebo-controlled, multicenter, phase III study of 6 months' duration in approximately 219 pediatric patients. Patients must have a clinical diagnosis of CKD (an eGFR ≥ 30 mL/min/1.73 m
conclusionFIONA is evaluating the use of finerenone in children with CKD and proteinuria. Should safety, tolerability, and efficacy be demonstrated, finerenone could become a useful additional therapeutic agent in managing proteinuria and improving kidney outcomes in children with CKD.
trial registrationClinicalTrials.gov NCT05196035. Registered on 19 January 2022.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.