The KidneyCARE Study: A National Registry Linking Patient-Reported Outcomes with Electronic Health Record (EHR) Data to Advance Kidney Disease Research

Background: Integrating patient-reported outcomes (PROs) into kidney research is essential to understanding the patient experience and advancing patient-centered care. However, these data are rarely collected at scale. The KidneyCARE™ (Community Access to Research Equity) Study, launched in 2024 by the National Kidney Foundation, is a national chronic kidney disease (CKD) registry that systematically links PROs with clinical and laboratory data from electronic health records (EHRs). Methods: English- or Spanish-speaking adults with any type or stage of kidney disease are recruited through public outreach or a health system partner. Participants complete surveys at baseline and at 6-month intervals, capturing demographics, medical and family history, lifestyle, and PROs via the EQ-5D-5L and KDQOL-36. Survey data are linked to clinical and lab data from EHRs, when available, for longitudinal, patient-centered analyses. Geisinger is the first health system contributing EHR data. Results: As of May 8, 2025, 1,419 patients from all 50 U.S. states and Puerto Rico had enrolled – 1,294 from the general population and 125 through Geisinger. To date, EHR data has been successfully linked with PROs for 53 Geisinger patients. Of the 809 who completed at least one survey question, 64% (519/809) identified as female, and 86% (697/809) identified as White, either alone or in combination with another race. The cohort spans all CKD stages and includes 21 diverse etiologies such as diabetes (15%; 121/809), hypertension (19%; 157/809), polycystic kidney disease (7%; 58/809), and glomerular diseases (13%; 105/809). Notably, 39% of participants either did not know or were unsure of their cause of kidney disease. 69% (980/1419) of participants consented to be contacted about clinical trial opportunities. Conclusion: The KidneyCARE Study demonstrates the feasibility of establishing a national registry linking PROs with EHR data. Preliminary findings reveal broad geographic and clinical representation, a wide range of kidney disease etiologies, and gaps in patients’ understanding of their condition – highlighting the need for improved patient education and engagement. This registry is building a valuable, trial-ready population for studies involving a broad range of kidney diseases. Additional efforts will be made to enrich racial and ethnic diversity within the registry. Funding: Commercial Support - Foundational support was provided through sponsorship from Bayer AG. AstraZeneca and Novartis are platinum sponsors, Boehringer-Ingelheim is a gold sponsor, and Apellis Pharmaceuticals is a silver sponsor.