Abstract: SA-PO0410
Finerenone Safety and Effectiveness Across CKD Stages in Type 2 Diabetes: Analysis of Four US Databases from the FOUNTAIN Platform
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
- Kovesdy, Csaba P., The University of Tennessee Health Science Center Department of Medicine, Memphis, Tennessee, United States
- Walsh, Michael, McMaster University, Hamilton, Ontario, Canada
- Oberprieler, Nikolaus G., Bayer AG, Berlin, Germany
- Liu, Fangfang, Bayer AG, Berlin, Germany
- Li, Li, Bayer AG, Berlin, Germany
- Argyriou, George, EPAM Systems Inc, Newtown, Pennsylvania, United States
- Farjat, Alfredo E., Bayer BV, Hoofddorp, Noord-Holland, Netherlands
- Rodriguez Molina, Daloha, Bayer AG, Berlin, Germany
Group or Team Name
- FOUNTAIN research platform
Background
Finerenone, a non-steroidal mineralocorticoid receptor antagonist, is increasingly used in chronic kidney disease (CKD) with type 2 diabetes (T2D). Real-world evidence is needed to contextualize effectiveness and safety across CKD stages in routine care.
Methods
We conducted a single-arm, new-user cohort study in four U.S. databases mapped to the OMOP Common Data Model (HealthVerity (HV), Optum EHR CKD (OEC), Optum Clinformatics Claims (CDM), Merative MarketScan (MS)) within the FOUNTAIN (FinerenOne mUltidatabase NeTwork for Evidence generAtIoN) research platform. Adults with CKD stages 2–4 and T2D initiating finerenone were included; kidney failure was excluded. Effectiveness was assessed as percent change in urine albumin-to-creatinine ratio (UACR) at ~4 months after finerenone initiation. Hyperkalemia was evaluated using diagnostic codes and a laboratory threshold (K+ ≥ 5.5 mmol/L), overall and by CKD stage.
Results
Cohort sizes were 30,623 (HV), 5,133 (OEC), 7,413 (CDM), and 2,390 (MS); 45,559 in total. Median follow-up was approximately one year. Across databases, initiators were predominantly older adults with common cardiometabolic comorbidities and frequent use of kidney-protective background therapies. At ~4 months, UACR decreased significantly and to a similar extent in patients with different CKD stages (figure). Hyperkalemia estimates were aligned with finerenone’s known safety profile, with higher risk associated with advanced CKD stages (table).
Conclusion
In four U.S. data sources, finerenone initiation in CKD with T2D was associated with early reductions in albuminuria and a predictable hyperkalemia safety profile across CKD stages. These findings support that finerenone is safe and effective across the CKD spectrum in routine practice.
Funding
- Commercial Support – Bayer AG