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Finerenone in Chinese Patients with Type 2 Diabetes and CKD: A FIGARO-DKD Subgroup Analysis

Visual abstract summarising finerenone in Chinese patients with type 2 diabetes and chronic kidney disease.

Clinical Bottom Line

A prespecified FIGARO-DKD subgroup analysis of 325 Chinese adults with type 2 diabetes and CKD found a significant reduction in the secondary kidney outcome with finerenone but no significant cardiovascular benefit. PICO summary and expert commentary.

Summary: In a prespecified subgroup of 325 Chinese adults with type 2 diabetes and chronic kidney disease enrolled in the double-blind FIGARO-DKD trial, finerenone did not significantly reduce the primary cardiovascular composite outcome (hazard ratio 0.91; 95% confidence interval 0.50-1.67), but the secondary kidney composite outcome was significantly lowered (hazard ratio 0.48; 95% confidence interval 0.29-0.79; p=0.0029). Hyperkalaemia was frequent in both arms, although hospitalisation and discontinuation for it were uncommon.

PICO Summary

ElementDetail
Population325 Chinese adults with type 2 diabetes and chronic kidney disease (UACR 30 to 5000 mg/g, eGFR 25 to 90 mL/min/1.73 m2) on optimised renin-angiotensin system blockade; prespecified subgroup of the multicentre, double-blind FIGARO-DKD randomised controlled trial.
InterventionOral finerenone, titrated per protocol (subgroup arm n approximately 162).
ComparisonMatching placebo added to standard care (subgroup arm n approximately 163).
OutcomePrimary cardiovascular composite (CV death, non-fatal MI, non-fatal stroke, or heart-failure hospitalisation): hazard ratio 0.91 (95% CI 0.50-1.67), not statistically significant. Secondary kidney composite (kidney failure, sustained eGFR decline of at least 40%, or kidney-related death): hazard ratio 0.48 (95% CI 0.29-0.79; p=0.0029), significant. Investigator-reported hyperkalaemia was frequent in both arms; hyperkalaemia leading to hospitalisation or discontinuation was low. No absolute risk reduction or number needed to treat was reported for this subgroup.
RCT Front Endocrinol · 2025

Finerenone in Chinese T2D with CKD

FIGARO-DKD subgroup · T2D + CKD

Trial design
Chinese T2D adults with CKD Enrolled & assessed RANDOMISED 1:1 Finerenone Oral finerenone + RAS n = 162 Placebo Placebo + standard care n = 163 CV composite (primary); kidney composite (secondary)
Between-group effect (95% CI)
0 (no difference) 0.2 2 CV composite+0.91Kidney composite+0.48 ✓ Hazard ratio (95% CI) · ✓ = significant
CV composite HR
0.91
95% CI 0.50-1.67
Kidney composite HR
0.48
95% CI 0.29-0.79
Kidney p-value
0.0029
significant
Subgroup n
325
~162 vs ~163
⬡ Bottom Line

In this underpowered FIGARO-DKD subgroup, finerenone did not significantly reduce the cardiovascular composite (HR 0.91) but significantly lowered the kidney composite (HR 0.48). Read as hypothesis-generating; monitor potassium.

Expert Commentary

This prespecified subgroup analysis should be read as hypothesis-generating rather than confirmatory. The primary endpoint of the parent FIGARO-DKD trial was the cardiovascular composite, and in these 325 Chinese participants that endpoint was not met: the hazard ratio of 0.91 carries a wide confidence interval that comfortably crosses unity, so no cardiovascular benefit can be claimed here. The signal that is statistically significant is the secondary kidney composite, where a hazard ratio of 0.48 is consistent with the renal protection seen across the broader finerenone programme. The single most important limitation is statistical power: with roughly 162 patients per arm and few hard events, a subgroup of this size is prone to unstable estimates, and the apparent magnitude of the kidney effect should be interpreted with caution rather than taken at face value. The analysis was supported by Bayer, the manufacturer of finerenone, and several authors are company employees, which warrants the usual circumspection. Can I use this with my patients? Cautiously yes for a Chinese adult with type 2 diabetes and albuminuric CKD already on a maximally tolerated renin-angiotensin system blocker, but the decision should rest on the pooled phase 3 evidence, not this underpowered subgroup, and serum potassium must be monitored given the frequent hyperkalaemia. Clinicians should weigh renal benefit against that risk and not extrapolate a cardiovascular advantage that this dataset does not support.

References

Li P, Zheng H, Ma J, Lu W, Li L, Liu F, et al. Impact of finerenone on chronic kidney disease progression in Chinese patients with type 2 diabetes: a FIGARO-DKD subgroup analysis. Front Endocrinol (Lausanne). 2025;16:1568438. doi:10.3389/fendo.2025.1568438

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