New Evidence Positions Finerenone as Foundational Therapy Across the CKD Spectrum

Three landmark trials published simultaneously in The New England Journal of Medicine, Journal of the American Medical Association, and The Lancet have substantially expanded the clinical case for finerenone (Kerendia; Bayer) beyond its established indication in chronic kidney disease (CKD) associated with type 2 diabetes (T2D).

Presented as late-breaking data at the 63rd European Renal Association Congress in Glasgow, the findings suggest that millions more patients with CKD—including those without diabetes and those with glomerular diseases—may benefit from the nonsteroidal mineralocorticoid receptor antagonist (MRA).^1,3,4

Finerenone works by selectively blocking the mineralocorticoid receptor, which when overactivated drives inflammation, fibrosis, and fluid retention in the kidneys and heart. Unlike older steroidal MRAs such as spironolactone (Aldactone; Pfizer) and eplerenone (Inspra; Pfizer), finerenone's distinct pharmacologic profile produces more potent anti-inflammatory and antifibrotic effects with a comparatively lower risk of adverse events.^1,3,4

FIND-CKD: Efficacy in Nondiabetic CKD

The phase 3 FIND-CKD trial (NCT05047263) enrolled 1584 adults without diabetes who had CKD, an estimated glomerular filtration rate (eGFR) of 25 to less than 90 mL/min/1.73 m², and albuminuria, all of whom were receiving background renin-angiotensin system (RAS) inhibitor therapy. Finerenone met the primary end point, significantly slowing the annual rate of eGFR decline by 0.7 mL/min/1.73 m² per year compared with placebo (95% CI, 0.3-1.1; P < .001). Finerenone also reduced the risk of a composite cardiovascular-kidney outcome—comprising kidney failure, a sustained eGFR decline of at least 57%, hospitalization for heart failure, or cardiovascular death—by 23% versus placebo (HR, 0.77 [95% CI, 0.60-0.99]; P = .043).^1,2

FIND-CKD Subanalysis: Benefits Extend to Glomerular Diseases

A prespecified exploratory subanalysis of the FIND-CKD population focused on the 903 participants with CKD due to glomerular diseases, including immunoglobulin A nephropathy (46.1%), focal segmental glomerulosclerosis (23.8%), and membranous nephropathy (10.0%). Among these patients, the total eGFR slope through 32 months was –3.50 mL/min/1.73 m² per year with finerenone compared with −4.23 mL/min/1.73 m² per year with placebo, a difference of about 0.73 mL/min/1.73 m² per year (95% CI, 0.22-1.24). Finerenone reduced albuminuria at month 12 by 42% (95% CI, 35%-48%) and lowered the risk of kidney failure or a 40% or greater eGFR decline (7.42 vs 9.60 events per 100 patient-years; HR, 0.74; 95% CI, 0.57-0.97).³

INFINITY: A Pooled View Across the CKD Spectrum

The INFINITY analysis, published in The Lancet, pooled individual participant data from FIND-CKD alongside the prior phase 3 FIDELIO-DKD (NCT02540993) and FIGARO-DKD (NCT02545049) trials in patients with T2D and CKD. In 14,574 individuals followed for a median of 3.1 years, finerenone reduced the risk of a composite kidney outcome comprising kidney failure or sustained 57% or more decline in eGFR (HR, 0.76; 95% CI, 0.68-0.86). Finerenone also reduced the risk of hospitalization for heart failure or cardiovascular death by 20% and all-cause mortality by 12% versus placebo. Investigators reported that these benefits were consistent regardless of diabetes status, CKD etiology, level of kidney function, or degree of albuminuria.^4-6

Unmet Need and Clinical Significance

The simultaneous publication of 3 major trial packages in a single week marks an unusual milestone in nephrology. Katherine R. Tuttle, MD, FASN, FACP, FNKF, executive director for research at Providence Inland Northwest Health and professor of medicine at the University of Washington School of Medicine, has emphasized the magnitude of the unmet need these data address.

"This is the first therapy in more than 3 decades that has been tested and shown benefit for people with T1D and CKD," she noted in a separate context related to the FINE-ONE trial in type 1 diabetes (T1D). "The unmet need is enormous, as the T1D population is now living longer but with a high burden of comorbidity, prominently CKD." The same framework applies broadly across nondiabetic CKD populations, where effective options have historically been scarce.^7,8

Hiddo J. L. Heerspink, PhD, principal investigator of the FINE-ONE trial and professor of clinical trials at the University Medical Center Groningen, noted that finerenone's mechanism addresses pathways that sodium-glucose cotransporter 2 inhibitors and glucagon-like peptide-1 receptor agonists cannot fill on their own in certain CKD populations. "MRA overactivation is implicated in many types of kidney diseases, including [both type 1 and type 2] diabetes, as well as other nephropathies," he noted, highlighting the breadth of the mechanistic rationale underlying these findings.⁷

Implications for Pharmacy Practice

Pharmacists should be aware that the primary safety concern with finerenone across all trials remains hyperkalemia. Tuttle noted that while elevated potassium occurred more often with finerenone than placebo in clinical trials, rates of treatment discontinuation and hospitalization due to hyperkalemia were low with appropriate monitoring protocols in place. "Potassium should be normal when these agents are initiated and monitored closely in people with CKD," she advised.⁷

For pharmacists counseling patients currently on background RAS inhibitor therapy who may be candidates for finerenone initiation, baseline and longitudinal monitoring of serum potassium and eGFR are essential. CYP3A4-mediated drug interactions—including contraindicated concomitant use with strong CYP3A4 inhibitors—require clinical attention as finerenone's use expands to broader CKD populations. Bayer has indicated plans to submit the FIND-CKD data to the FDA to extend finerenone's indication to nondiabetic CKD.⁷

REFERENCES

1. Heerspink HJL, Neuen BL, Agarwal R, et al. Finerenone in persons with chronic kidney disease without diabetes. N Engl J Med. Published Online June 4, 2026. Accessed June 12, 2026. doi:10.1056/NEJMoa2604625

2. A trial to learn how well finerenone works and how safe it is in adult participants with non-diabetic chronic kidney disease (FIND-CKD). ClinicalTrials.gov Identifier: NCT05047263. Updated February 13, 2026. Accessed June 12, 2026. https://clinicaltrials.gov/study/NCT05047263

3. Neuen BL, Perkovic V, Agarwal R, et al. Finerenone in patients with chronic kidney disease due to glomerular diseases: a randomized clinical trial. JAMA. Published Online June 5, 2026. Accessed June 12, 2026. doi:10.1001/jama.2026.9923

4. Neuen BL, Heerspink HJL, Perkovic V, et al. Efficacy and safety of finerenone in patients with chronic kidney disease: an individual participant data pooled analysis (INFINITY). Lancet. 2026;407(10546):2375-2386. doi:10.1016/S0140-6736(26)01009-3

5. Efficacy and safety of finerenone in subjects with type 2 diabetes mellitus and diabetic kidney disease (FIDELIO-DKD). ClinicalTrials.gov Identifier: NCT02540993. Updated July 24, 2023. Accessed June 12, 2026. https://clinicaltrials.gov/study/NCT02540993

6. Efficacy and safety of finerenone in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease (FIGARO-DKD). ClinicalTrials.gov Identifier: NCT02545049. Updated April 15, 2022. Accessed June 12, 2026. https://clinicaltrials.gov/study/NCT02545049

7. Tuttle KR, Heerspink HJL, Halpern L. Experts weigh in on finerenone’s priority review for CKD in type 1 diabetes. Pharmacy Times. Published June 1, 2026. Accessed June 12, 2026. https://www.pharmacytimes.com/view/experts-weigh-in-on-finerenone-s-priority-review-for-ckd-in-type-1-diabetes?ekey=bGhhbHBlcm5AbWpobGlmZXNjaWVuY2VzLmNvbQ%3D%3D

8. A Study to Learn How Well the Study Treatment Finerenone Works and How Safe it is in People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 1 Diabetes (FINE-ONE). ClinicalTrials.gov Identifier: NCT05901831. Updated October 21, 2025. Accessed June 12, 2026. https://clinicaltrials.gov/study/NCT05901831