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Finerenone linked to improved KDIGO risk categories in T2D and CKD patients

Finerenone linked to improved KDIGO risk categories in T2D and CKD patients
Photo by Navy Medicine / Unsplash
Key Takeaway
Consider that finerenone-associated KDIGO risk changes are linked to CV outcomes in T2D and CKD.

This was a post hoc subanalysis of a randomized controlled trial, examining patients with type 2 diabetes and chronic kidney disease. The analysis compared outcomes in those treated with finerenone versus placebo over a 36-month follow-up period, focusing on changes in KDIGO risk categories and their relationship to a cardiovascular composite outcome.

The main results showed finerenone was associated with a higher likelihood of KDIGO risk category improvement (OR 1.47, 95% CI 1.31-1.65; p < 0.0001) and a lower likelihood of worsening (OR 0.83, 95% CI 0.77-0.90; p < 0.0001) compared to placebo. Furthermore, improvement in KDIGO risk category was associated with a reduced risk of the CV composite outcome (HR 0.82, 95% CI 0.68-0.99; p = 0.043), while worsening was associated with an increased risk (HR 1.29, 95% CI 1.06-1.56; p = 0.01).

Safety and tolerability data were not reported in this subanalysis. The key limitation is that this is a post hoc subanalysis, which means the findings are hypothesis-generating and should not be considered definitive evidence of causality. The study was funded by Bayer AG, the manufacturer of finerenone.

For clinical practice, these results suggest a potential link between finerenone's effect on CKD progression (as measured by KDIGO categories) and cardiovascular risk in this population. However, clinicians should interpret these associations cautiously, recognizing that KDIGO category changes are surrogate endpoints and that the analysis does not establish direct causation.

Study Details

Study typeRct
EvidenceLevel 2
PublishedApr 2026
View Original Abstract ↓
AIMS: In FIDELITY, finerenone improved kidney and cardiovascular (CV) outcomes in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). The Kidney Disease: Improving Global Outcomes (KDIGO) guidelines categorise CKD progression risk based on estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio (UACR). This FIDELITY post hoc subanalysis investigated KDIGO risk category changes associated with finerenone. METHODS: Improvement or worsening in KDIGO risk category was defined by variation from baseline, with specified eGFR and UACR changes. Association of these category changes with a CV composite outcome was assessed. RESULTS: Finerenone therapy led to a higher likelihood of KDIGO risk category improvement (odds ratio [OR], month 36: 1.47; 95% confidence interval [CI], 1.31-1.65; p < 0.0001) and lower likelihood of worsening (OR, month 36: 0.83; 95% CI, 0.77-0.90; p < 0.0001) vs. placebo. Risk category improvement reduced the CV composite outcome risk (hazard ratio [HR]: 0.82; 95% CI, 0.68-0.99; p = 0.043) while worsening increased this risk (HR: 1.29; 95% CI, 1.06-1.56; p = 0.01). CONCLUSIONS: Finerenone therapy is associated with greater improvement and less worsening in KDIGO risk vs. placebo. The category changes are associated with lower risk of CV events in patients with CKD and T2D. TRIAL REGISTRATION NUMBER: FIDELIO-DKD (NCT02540993) and FIGARO-DKD (NCT02545049) are registered with ClinicalTrials.gov (funded by Bayer AG).
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