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Please prepare and upload your E-Poster no later than March 14, 2026 11.59PM CET. After this date, you will no longer be able to prepare and upload your E-poster and it will not be displayed and accessible on the congress website.
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The CONFIDENCE trial demonstrated that simultaneous initiation of finerenone and empagliflozin resulted in a marked reduction in urinary albumin-to-creatinine ratio (UACR). Simultaneous initiation also led to an acute reduction in estimated glomerular filtration rate (eGFR). The frequency of the acute eGFR reduction, its determinants, and associations with changes in clinical parameters are unknown.
The CONFIDENCE trial randomized 818 adults with type 2 diabetes and chronic kidney disease to empagliflozin 10 mg, finerenone 10 or 20 mg, or their combination. We defined acute reduction in eGFR as the change in eGFR from baseline to day 14. We then compared the proportion of participants who experienced reductions in eGFR >10%, >0 to 10%, or an increase in eGFR among treatment groups, and assessed the association of acute reduction in eGFR by quartile with UACR, systolic blood pressure (BP), kidney injury biomarkers, and safety outcomes. Kidney injury biomarkers were measured from first morning void urine samples collected at baseline and day 30 using Olink ExploreHT proteomics.
A total of 761 (93%) patients had eGFR data available at baseline and day 14. Mean baseline eGFR (mL/min/1.73 m2 [standard deviation]) was 54.2 (17) and median baseline UACR was 579 (interquartile range 292, 1092). The least-squares mean reductions from baseline in eGFR (mL/min/1.73 m2 [95% CI]) on day 14 were −6.1 (−7.1, −5.1), −1.3 (−2.3, −0.3), and −4.0 (−5.1, −3.0) in the combination, finerenone, and empagliflozin groups, respectively. Reductions in eGFR were mostly reversible after a 4-week washout in the overall population and prespecified subgroups (by eGFR, UACR, and diuretic use). An acute reduction in eGFR >10% was more common in the combination group (148 [58.5%]) compared with the finerenone (75 [30.0%]) and empagliflozin groups (122 [47.3%]). Characteristics independently associated with an acute reduction in eGFR >10% were higher baseline eGFR (odds ratio [OR] 1.09 [95% CI 1.04, 1.14]), higher systolic BP (OR 1.07 [95% CI 1.01, 1.13]), and combination treatment (OR 1.6 [95% CI 1.1, 2.3] vs empagliflozin; OR 2.9 [95% CI 2.0, 4.3] vs finerenone). On day 14, changes from baseline in UACR and systolic BP were associated with eGFR changes in all treatment groups (Figure). Rates of adverse events with combination treatment were comparable to those with finerenone or empagliflozin regardless of acute changes in eGFR. Urinary kidney injury biomarkers, including clusterin, cystatin-C, neutrophil gelatinase-associated lipocalin (NGAL), and kidney injury molecule-1 (KIM-1) were not significantly increased from baseline at day 30 with finerenone, empagliflozin, or their combination. These biomarkers were also not differentially regulated by either drug in patients with >10% eGFR change versus those without. Osteopontin levels were modestly increased (≤10%) with empagliflozin and combination therapy, but did not change with finerenone at day 30.
Acute reduction in eGFR was common and reversible with simultaneous initiation of finerenone and empagliflozin, was not associated with more frequent adverse events or an unfavorable kidney injury biomarker profile, and correlated with changes in UACR and systolic BP. Acute change in eGFR with finerenone and empagliflozin appears to reflect a favorable hemodynamic treatment response.
