Highlights of 2025: the rise of finerenone

If the late 2010s and early 2020s was the story of SGLT2 inhibitors for the treatment of cardiovascular/renal/metabolic (CVRM) conditions, then the sub-plot of the last few years has been about the non-steroidal mineralocorticoid receptor antagonist (nsMRA) finerenone. The CKD trials involving finerenone will be well known to nephrologists.

FIDELIO-DKD included patients with more advanced diabetic kidney disease (DKD; eGFR down to 25 mL/min/1.73 m²) and found that those randomised to finerenone had a reduction in progression to kidney failure or drop in eGFR of 40%.¹ FIGARO-DKD was a randomised controlled trial (RCT) looking at the effects of finerenone compared to placebo in patients with type 2 diabetes and earlier stage DKD on cardiovascular mortality and morbidity.² The trial was positive, with a significant mortality benefit shown in the finerenone group compared to control subjects. Both trials led to recommendations for the addition of finerenone to optimised RAAS inhibitor therapies and SGLT2 inhibitors for the treatment of DKD in patients with sufficient proteinuria.³

These studies were compelling but, at the time, rather dwarfed by the SGLT2 inhibitor outcome studies. Fast-forward to 2025 and the evidence around both these agents has moved on when tested in combination. The CONFIDENCE study published earlier this year (see summary) and was an RCT of finerenone monotherapy, empagliflozin monotherapy, or the combination of both finerenone and empagliflozin in patients with type 2 diabetes and albuminuric CKD.⁴ As in all these studies, subjects were established on maximised RAAS inhibitor therapy prior to enrolment. 

The results were compelling, with a reduction from baseline urine ACR in patients randomised to combined finerenone and empagliflozin therapy that was 29% greater than in those randomised to finerenone monotherapy and 32% greater than in those randomised to empagliflozin monotherapy. More than half of those patients who received combination treatment achieved a >50% reduction in uACR, as compared to around a third with either finerenone or empagliflozin monotherapy. 

This is further evidence of the effectiveness of finerenone and adds to the thought that it may soon be considered a treatment for cardiorenal disease. It follows publication of the FINEARTS-HF study at the end of 2024, which showed a reduction in heart failure events or cardiovascular death in patients with heart failure with mildly reduced or preserved ejection fraction compared to placebo.⁵ Incidentally, in FINEARTS-HF nearly 50% of the study population had an eGFR <60 mL/min/1.73 m².

The CONFIDENCE study has moved finerenone more into the foreground of therapies for proteinuric DKD and should give real confidence to clinicians about the powerful synergistic effects of the treatment in combination with SGLT2i therapies. Moreover, the fact that there is growing evidence for the cardiovascular benefits of therapy in populations with or at risk of kidney disease, and in areas of disease overlap such as patients with heart failure with preserved ejection fraction, means that the treatment is likely to play an important role in preventing disease progression in CKD and CVRM conditions. 

References

1. Bakris GL, Agarwal R, Anker SD et al; FIDELIO-DKD Investigators (2020) Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes. N Engl J Med 383: 2219–29
2. Pitt B, Filippatos G, Agarwal R et al; FIGARO-DKD Investigators (2021) Cardiovascular events with finerenone in kidney disease and type 2 diabetes. N Engl J Med 385: 2252–63
3. NICE (2023) Finerenone for treating chronic kidney disease in type 2 diabetes (TA877). NICE, London. Available at: https://www.nice.org.uk/guidance/ta877 (accessed 01.12.25)
4. Agarwal R, Green JB, Heerspink HJL et al; CONFIDENCE Investigators (2025) Finerenone with empagliflozin in chronic kidney disease and type 2 diabetes. N Engl J Med 393: 533–43
5. Solomon SD, McMurray JJV, Vaduganathan M et al; FINEARTS-HF Committees and Investigators (2024) Finerenone in heart failure with mildly reduced or preserved ejection fraction. N Engl J Med 391: 1475–85