Abstract: SA-PO0419
Comparing EMPA-KIDNEY Trial Participants with Trial-Eligible, Real-World Patients
Session Information
- CKM: Clinical - Epidemiology and Outcomes
October 24, 2026 | Location: Exhibit Hall A, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Cardiovascular-Kidney-Metabolic Health
- 602 Cardiovascular-Kidney-Metabolic Health: Clinical
Authors
- Marthi, Amarnath, The University of North Carolina at Chapel Hill Gillings School of Global Public Health, Chapel Hill, North Carolina, United States
- Jonsson Funk, Michele, The University of North Carolina at Chapel Hill Gillings School of Global Public Health, Chapel Hill, North Carolina, United States
- Mottl, Amy K., The University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, United States
Background
Participants enrolled in clinical trials may differ from patients who meet trial eligibility criteria in clinical care, limiting understanding of the real-world treatment benefit. We assess the representativeness of EMPA-KIDNEY by comparing trial participants with trial-eligible adults receiving care in a large, statewide health system.
Methods
Using electronic health records from the University of North Carolina Health System (UNCHS), we emulated EMPA-KIDNEY eligibility criteria among adults with CKD across outpatient Primary Care, Nephrology, relevant sub-specialty clinics between 2015-2019. Eligibility was assessed at each visit and cohort characteristics were defined by picking one eligible visit per patient, at random. UNCHS patients were compared to EMPA-KIDNEY participants using standardized mean differences. All-cause mortality for the UNCHS cohort was estimated through linkage with state death records.
Results
We identified 7,648 trial-eligible patients predominantly in Primary Care clinics (71%). Compared with trial participants, trial-eligible patients were older, more often female, had a higher prevalence of diabetes and cardiovascular disease, higher eGFR and lower albuminuria (Table 1). Patients receiving nephrology care were most similar to trial participants. Two-year mortality in the trial-eligible cohort was 11.7% (95% confidence interval 11.0-12.4), more than double that observed in EMPA-KIDNEY.
Conclusion
Despite broad eligibility criteria, EMPA-KIDNEY participants differed meaningfully from trial-eligible UNCHS patients. These patients experienced substantially higher mortality than that observed in the trial. For existing trials, calibrating trial data to clinical populations can help estimate the public health impact of therapeutic advances in CKD. The described approach may assist future trials in aligning design, recruitment, and implementation strategies with real-world disease burden to improve translation of trial evidence to clinical practice.
Funding
- Other NIH Support