SAFETY ANALYSES OF INITIAL EGFR DECLINE WITH FINERENONE, EMPAGLIFLOZIN, AND COMBINATION THERAPY, AND BIOMARKERS OF ACUTE KIDNEY INJURY

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Abstract Title *

SAFETY ANALYSES OF INITIAL EGFR DECLINE WITH FINERENONE, EMPAGLIFLOZIN, AND COMBINATION THERAPY, AND BIOMARKERS OF ACUTE KIDNEY INJURY

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Co-author 1

Hiddo J. L. Heerspink h.j.lambers.heerspink@umcg.nl University of Groningen; University Medical Center Groningen Department of Clinical Pharmacy and Pharmacology Groningen Netherlands *

Co-author 2

Amy K. Mottl amy_mottl@med.unc.edu UNC School of Medicine University of North Carolina Kidney Center Chapel Hill, NC United States -

Co-author 3

Julio Rosenstock juliorosenstock@dallasdiabetes.com Velocity Clinical Research at Medical City Dallas Diabetes Research Consulting Dallas, TX United States -

Co-author 4

Masaomi Nangaku mnangaku@m.u-tokyo.ac.jp The University of Tokyo Graduate School of Medicine Division of Nephrology and Endocrinology Tokyo Japan -

Co-author 5

Janet B. McGill jmcgill@wustl.edu Washington University in St. Louis Division of Endocrinology, Metabolism & Lipid Research St. Louis, MO United States -

Co-author 6

Jennifer B. Green Jennifer.Green@duke.edu Duke University School of Medicine Division of Endocrinology, Department of Medicine and Duke Clinical Research Institute Durham, NC United States -

Co-author 7

Peter Rossing peter.rossing@regionh.dk Steno Diabetes Center Copenhagen and University of Copenhagen Department of Clinical Medicine Copenhagen Denmark -

Co-author 8

Muthiah Vaduganathan mvaduganathan@bwh.harvard.edu Brigham and Women's Hospital and Harvard Medical School Division of Cardiovascular Medicine Boston, MA United States -

Co-author 9

Johannes F.E. Mann prof.j.mann@googlemail.com KfH Kidney Centre Munich and Friedrich Alexander University Department of Nephrology & Hypertension Munchen Germany -

Co-author 10

Mario Berger mario.berger@bayer.com Bayer AG R&D, Translational Sciences, Pharmaceuticals Wuppertal Germany -

Co-author 11

Na Li linda.li@bayer.com Bayer Healthcare Global Medical and Evidence Beijing China -

Co-author 12

Meike Brinker meike.brinker@bayer.com Bayer AG Cardiology and Nephrology Clinical Development Wuppertal Germany -

Co-author 13

Charlie Scott charlie.scott@bayer.com Bayer Healthcare Inc Clinical Statistics and Analytics Whippany, NJ United States -

Co-author 14

Li Li li.li9@bayer.com Bayer AG Global Medical and Evidence Berlin Germany -

Co-author 15

Rajiv Agarwal ragarwal@iu.edu Richard L. Roudebush VA Medical Center, Indiana University School of Medicine Division of Nephrology Indianapolis, IN United States -

Introduction

The phase 2 CONFIDENCE trial (NCT05254002) assessed the efficacy and safety of combined initiation of the nonsteroidal mineralocorticoid receptor antagonist, finerenone and the sodium–glucose cotransporter 2 inhibitor, empagliflozin, in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). The CONFIDENCE trial met its primary endpoint of establishing a greater reduction in albuminuria following initial combination therapy when compared with either therapy alone. Finerenone and empagliflozin are both associated with an acute dip in estimated glomerular filtration rate (eGFR). This analysis of CONFIDENCE evaluated the association of acute change in eGFR with biomarkers of acute kidney injury (AKI).

Methods

Participants in CONFIDENCE were aged ≥18 years and diagnosed with CKD and T2D with UACR of 100 to ≤5000 mg/g, an estimated glomerular filtration rate of 30 to 90 mL/min/1.73 m2, and on a renin-angiotensin system inhibitor. Participants were randomized 1:1:1 to once-daily finerenone (10 or 20 mg) plus empagliflozin (10 mg), finerenone (10 or 20 mg) plus placebo, or empagliflozin (10 mg) plus placebo. Change in eGFR from baseline to day 14 (acute phase), biomarker and safety events (AKI) were assessed.

Results

Data on the acute change in eGFR following randomization to treatment, and its association with biomarkers of AKI will be presented.

Conclusion

The results from this analysis will offer insights on the association of early decline in eGFR following initiation of combination treatment, finerenone alone or empagliflozin alone, and its association with biomarkers of AKI.

Kewords