Kidney Week

Abstract: TH-PO1204

Joint Effects of Urine Albumin-to-Creatinine Ratio (UACR) and eGFR on Efficacy and Safety with Simultaneous Initiation of Finerenone and an SGLT2 Inhibitor in the CONFIDENCE Trial

Session Information

• Late-Breaking Research Posters
  November 06, 2025 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Diabetic Kidney Disease

• 702 Diabetic Kidney Disease: Clinical

Authors

• Mottl, Amy K., University of North Carolina Kidney Center, UNC School of Medicine, Chapel Hill, North Carolina, United States

Amy K. Mottl, MD, MPH, FASN

• Scott, Charlie, Clinical Statistics and Analytics, Bayer US LLC, Whippany, New Jersey, United States

Charlie Scott, MS

• Li, Li, Bayer AG, Berlin, Germany

Li Li, MD, MPH, MBA

• Agarwal, Rajiv, Division of Nephrology, Richard L. Roudebush VA Medical Center & Indiana University School of Medicine, Indianapolis, Indiana, United States

Rajiv Agarwal, MD, MS, FASN

Background

CONFIDENCE (NCT05254002) demonstrated simultaneous initiation of finerenone and a SGLT2i to be well-tolerated and superior to either monotherapy in reducing UACR at 180 days. Albuminuria and eGFR are independent, additive risk factors for kidney endpoints. This analysis reports on the influence of baseline eGFR and UACR on the safety and efficacy of the studied treatments.

Methods

CONFIDENCE was a randomized, double dummy trial in adults with T2D and CKD with eGFR 25–90 mL/min/1.73 m² and UACR 100–5000 mg/g. Participants were randomized 1:1:1 to finerenone, empagliflozin, or both, on a background of maximal ACEi/ARB. Linear mixed models and logistic regression were used to model the joint effects of baseline UACR and eGFR on UACR reduction from baseline to day 180.

Results

Baseline characteristics were generally well-balanced across treatment groups. In a mixed-effects model analysis, patients with higher baseline eGFR and greater degrees of albuminuria experienced more pronounced reduction in albuminuria (Figure). In an adjusted logistic regression model, combination therapy was associated with increased odds of achieving a ≥30% reduction in UACR from baseline to day 180, compared to monotherapy with finerenone (OR 2.14 [95% CI 1.45–3.17]) or empagliflozin (OR 2.21 [95% CI 1.50–3.27]). Other independent predictors were age (OR 1.23 per 10 years [1.05–1.45]), female sex (OR 1.95 [1.32–2.86]), and the presence of ASCVD (OR 1.63 [1.13–2.35]). AEs occurred with similar frequency across the eGFR/UACR categories. However, hyperkalemia was observed more frequently in individuals with lower eGFR and higher albuminuria in all treatment groups. Notably, treatment-induced changes in serum K⁺ were similar across all strata.

Conclusion

Greater albuminuria lowering is seen with a higher baseline eGFR or UACR, older age, in women, and those with ASCVD. Benefits of combination therapy were not dependent on these factors.

Funding

• Commercial Support – The study and this analysis were funded by Bayer AG, Leverkusen, Germany. Medical writing and/or editorial assistance was provided by Anna Thompson, PhD, and Melissa Ward, BA, both of Scion (a division of Prime, London, UK). This assistance was funded by Bayer AG, Wuppertal, Germany according to Good Publication Practice guidelines.

Digital Object Identifier (DOI)

• doi: 10.1681/ASN.2025fxgzpywn