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Abstract: TH-PO1142

Impact of Finerenone-Induced Albuminuria Reduction on CKD Outcomes in Type 2 Diabetes: A Causal Mediation Analysis

Session Information

  • Late-Breaking Posters
    November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: Diabetic Kidney Disease

  • 702 Diabetic Kidney Disease: Clinical


  • Agarwal, Rajiv, Indiana University School of Medicine, Indianapolis, Indiana, United States
  • Tu, Wanzhu, Indiana University Purdue University Indianapolis, Indianapolis, Indiana, United States
  • Farjat, Alfredo E., Bayer plc, Reading, Berkshire, United Kingdom
  • Farag, Youssef MK, Bayer US, LLC, Cambridge, Massachusetts, United States
  • Toto, Robert D., The University of Texas Southwestern Medical Center, Dallas, Texas, United States
  • Kaul, Sanjay, Cedars-Sinai Medical Center, Los Angeles, California, United States
  • Lawatscheck, Robert, Bayer AG, Berlin, Germany
  • Rohwedder, Katja, Bayer AG, Berlin, Berlin, Germany
  • Ruilope, Luis M., Institute of Research imas12, Madrid, Spain
  • Rossing, Peter, Steno Diabetes Center Copenhagen, Herlev, Denmark
  • Pitt, Bertram, University of Michigan, Ann Arbor, Michigan, United States
  • Filippatos, Gerasimos, Ethniko kai Kapodistriako Panepistemio Athenon, Athens, Attica, Greece
  • Anker, Stefan D., Charite Universitatsmedizin Berlin, Berlin, Berlin, Germany
  • Bakris, George L., University of Chicago Pritzker School of Medicine, Chicago, Illinois, United States

Group or Team Name

  • FIDELIO-DKD and FIGARO-DKD Investigators

In patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), early reduction in urine albumin-to-creatinine ratio (UACR) is associated with improved kidney and cardiovascular outcomes. This post hoc mediation analysis quantified finerenone-induced kidney and cardiovascular (CV) risk reductions over a 4-year period mediated by a change in log UACR between baseline and month 4.


The analysis used pooled data from two phase 3 trials (NCT02540993 and NCT02545049) investigating the effect of finerenone vs placebo in patients with CKD and T2D. Separate causal mediation analyses were conducted for the composite kidney (kidney failure, sustained ≥57% decrease in estimated glomerular filtration rate from baseline, or kidney death) and CV (CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) outcomes. The mediated effect of UACR reduction on the risk of cardiorenal outcomes was analyzed as a continuous variable (main finding) and as a dichotomous variable using the guideline-recommended 30% reduction threshold.


Baseline median UACR was 514 mg/g (N=12,512). UACR reduction, analyzed as a continuous variable, mediated 83% and 36% of the treatment effect of finerenone on the kidney and CV outcomes, respectively (Figure 1 C and D). When UACR change was analyzed as a dichotomous variable, the proportions mediated were 62% and 25%, respectively (Figure 1 A and B).


In patients with CKD and T2D, early albuminuria reduction with finerenone mediated a large proportion of the treatment effect against CKD progression and a modest proportion of the effect against CV outcomes.


  • Commercial Support – Bayer AG