Document Type
Article
Publication Date
12-2026
Identifier
DOI: 10.1007/s00467-026-07435-y; PMCID: PMC13672603
Abstract
BACKGROUND: In recent years, real-world data have been increasingly used to enrich data from interventional studies on treatment effectiveness. To explore the viability of hybrid study designs in pediatric chronic kidney disease (CKD), we assessed the feasibility of identifying a real-world cohort of children with CKD and severely increased proteinuria who satisfied adapted eligibility criteria from the FIONA trial.
METHODS: We used data from the Optum® de-identified Electronic Health Record dataset (Optum® EHR) to identify and characterize children with CKD and severely increased proteinuria in records from January 2013 to December 2022. Patients were identified based on two sets of estimated glomerular filtration rate (eGFR)/serum creatinine and urine protein-to-creatinine ratio (UPCR) measures within a 90- to 365-day period (final date = index). Patients were required to satisfy adapted eligibility criteria from the FIONA trial and have a baseline prescription for angiotensin-converting enzyme inhibitors (ACEi)/angiotensin receptor blockers (ARBs). Patients were stratified by eGFR and UPCR. Patient characteristics, comorbidities, and medications were descriptively reported.
RESULTS: We identified a total of 381 children with CKD and severely increased proteinuria (median age: 14 years; 52.6% male), among whom 80.8% had eGFR ≥ 60 mL/min/1.73 m2 and 69.0% had UPCR > 1 g/g. The patient distribution by CKD stage was: G1, 50.9%; G2, 29.9%; G3-4, 19.2%. Among 397 patients who were excluded given no baseline ACEi/ARB use, > 20% initiated ACEi/ARBs within 6 months following index.
CONCLUSIONS: Our study demonstrated the feasibility of identifying a real-world pediatric cohort with CKD and severely increased proteinuria using adapted criteria from the FIONA trial. Findings from this study highlight factors that should be considered in the design of future hybrid studies evaluating treatment effectiveness using data from both trials and the real world.
Journal Title
Pediatric nephrology (Berlin, Germany)
Volume
41
Issue
12
First Page
4487
Last Page
4500
MeSH Keywords
Humans; Proteinuria; Male; Electronic Health Records; Renal Insufficiency, Chronic; Child; Adolescent; Female; United States; Glomerular Filtration Rate; Retrospective Studies; Angiotensin-Converting Enzyme Inhibitors; Creatinine; Child, Preschool; Severity of Illness Index; Angiotensin Receptor Antagonists; Feasibility Studies
PubMed ID
42406069
Keywords
Electronic health records; Pediatric chronic kidney disease; Proteinuria; Real-world data
Recommended Citation
Warady BA, Heeg S, Farjat AE, et al. Characterizing children with chronic kidney disease and severe proteinuria in the United States: a retrospective analysis using electronic health records. Pediatr Nephrol. 2026;41(12):4487-4500. doi:10.1007/s00467-026-07435-y
Comments
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Publisher's Link: https://link.springer.com/article/10.1007/s00467-026-07435-y