

, Kengo Furuichi4
, Takashi Wada5
1Nephrology Center, Toranomon Hospital, Tokyo, Japan
2Nephrology Center, Toranomon Hospital Kajigaya, Kanagawa, Japan
3Okinaka Memorial Institute for Medical Research, Tokyo, Japan
4Department of Nephrology, Kanazawa Medical University School of Medicine, Ishikawa, Japan
5Department of Nephrology and Rheumatology, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan
Nephrology Center, Toranomon Hospital, 2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, Japan, E-mail: m.yamanouchi@toranomon.gr.jp Copyright © 2026 Korean Diabetes Association
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
CONFLICTS OF INTEREST
Masayuki Yamanouchi has received lecture honoraria from Bayer and has served on advisory boards for Bayer. The other authors declare no conflicts of interest.
FUNDING
None
ACKNOWLEDGMENTS
None
| Study | Design/population | Asian representation | Main kidney/albuminuria findings relevant to Asia | Safety message | Evidentiary role/main limitation |
|---|---|---|---|---|---|
| ARTS-DN Japan | Phase IIb, placebo- controlled trial in Japanese patients with T2DM and albuminuric CKD receiving RAS inhibition | 96 Japanese participants | Nominally significant short-term UACR reduction at day 90; supportive early Japanese signal | No major hyperkalemia signal was reported, and serious adverse events were not increased | Early Japanese supportive signal; not part of the phase III evidentiary foundation and not designed for long-term kidney outcomes [27] |
| FIDELIO-DKD | Phase III randomized trial in patients with T2DM and CKD receiving optimized RAS inhibition | 5,674 Total participants; included Asian participants | Established finerenone as an evidence-based add-on therapy in T2DM and albuminuric CKD and formed part of the global foundation for later Asian interpretation | Hyperkalemia increased vs. placebo, but discontinuation due to hyperkalemia remained infrequent (2.3% vs. 0.9%) | Global trial; not designed for Asia-specific inference [13] |
| FIDELIO-DKD Asia | Post hoc analysis of Asian participants enrolled in FIDELIO-DKD | 1,327 Participants from the Asian region | Kidney composite HR 0.70 (95% CI, 0.56–0.87) for sustained ≥40% decline in eGFR, kidney failure, or kidney-related death; more stringent kidney composite HR 0.73 (95% CI, 0.55–0.97); UACR reduced by 31% at month 4 | Hyperkalemia was more frequent with finerenone, but discontinuation (2.1%) and hospitalization (1.5%) remained uncommon | Regional post hoc subgroup analysis from a single phase III trial; supportive rather than foundational [17] |
| FIDELIO-DKD China | Prespecified subgroup analysis of Chinese participants in FIDELIO-DKD | 372 Chinese participants | Kidney composite HR 0.59 (95% CI, 0.39–0.88) for sustained ≥40% decline in eGFR, kidney failure, or kidney-related death; UACR reduced by 26.8% at month 4 | Hyperkalemia-related discontinuation (4.3%) and hospitalization (1.6%) remained uncommon overall | Country-specific subgroup analysis; relatively small sample size [18] |
| FIGARO-DKD | Phase III randomized trial in a broader T2DM and CKD population receiving optimized RAS inhibition | 7,437 Total participants; included Asian participants | Extended the finerenone evidence base across a broader CKD spectrum and contributed to the pooled global foundation for Asian interpretation | Hyperkalemia increased vs. placebo, but permanent discontinuation (1.2% vs. 0.4%) and hospitalization (0.6% vs. 0.1%) remained uncommon | Global trial; not designed for Asia-specific inference [14] |
| FIGARO-DKD China | Prespecified subgroup analysis of Chinese participants in FIGARO-DKD | 325 Chinese participants | Key secondary kidney outcome HR 0.48 (95% CI, 0.29–0.79); more stringent kidney composite HR 0.40 (95% CI, 0.19–0.83); UACR reduced by 39% at month 4; chronic eGFR slope difference 2.25 mL/min/1.73 m2/year (95% CI, 0.75–3.76) | Investigator-reported hyperkalemia was similar between treatment arms; clinically meaningful hyperkalemia events were uncommon | Country-specific subgroup analysis; exploratory because of limited sample size and event counts [19] |
| FIDELITY | Prespecified pooled analysis of FIDELIO-DKD and FIGARO-DKD | 12,990 Total participants | Established the global cardiorenal foundation for finerenone in T2DM and albuminuric CKD | Hyperkalemia increased with finerenone versus placebo, but permanent discontinuation remained infrequent (1.7% vs. 0.6%) | Prespecified pooled analysis forming the global cardiorenal foundation for later Asian interpretation; not a standalone trial [15] |
| FIDELITY Asian | Asian subgroup analysis of FIDELITY | 2,858 Asian participants (22.0%); 92.3% enrolled from sites in Asia | Kidney composite HR 0.64 (95% CI, 0.50–0.82) for sustained ≥57% decline in eGFR, kidney failure, or kidney-related death; broader kidney composite HR 0.67 (95% CI, 0.56–0.80) for sustained ≥40% decline in eGFR, kidney failure, or kidney- related death; UACR reduced by 33% at month 4; chronic eGFR slope difference 1.08 mL/min/1.73 m2/year (95% CI, 0.53–1.63) | Hyperkalemia was more frequent with finerenone, but hospitalization and permanent discontinuation remained uncommon under trial conditions | Main pooled Asian interpretive framework; does not establish a uniquely Asian biologic treatment effect [20] |
| FIDELITY Asian by baseline kidney function | Asian pooled subanalysis focused on chronic eGFR slope, UACR regression, and safety according to baseline kidney function | 2,858 Asian participants | Chronic eGFR slope difference 1.08 mL/min/1.73 m2/year (95% CI, 0.53–1.63); UACR reduced by 34% at month 4; regression from high or very high albuminuria to normal or mildly increased albuminuria 39.5% vs. 14.8% | Overall adverse events were broadly similar between groups; hyperkalemia remained monitor-dependent | Post hoc pooled subanalysis; interpretation applies within the studied population [21] |
| CONFIDENCE | Randomized trial of finerenone, empagliflozin, or simultaneous combination in patients with T2DM, eGFR 30–90 mL/min/1.73 m2, and UACR 100–5,000 mg/g on background RAS inhibition | 818 Randomized participants | In the overall trial population, simultaneous initiation yielded a 29% greater short-term UACR reduction than finerenone alone and a 32% greater reduction than empagliflozin alone | Hyperkalemia leading to drug discontinuation was uncommon; combination therapy did not eliminate potassium risk | UACR-endpoint trial; not a hard kidney outcome trial [28] |
| CONFIDENCE Asia | Prespecified participant-level exploratory analysis of Asian participants in CONFIDENCE | 360 Asian participants (46% of trial population) | Combination reduced UACR by 53% at day 180, corresponding to a 30% greater reduction than finerenone alone and a 34% greater reduction than empagliflozin alone | Hyperkalemia remained clinically relevant in Asian participants, including with combination therapy | Supports short-term additive albuminuria lowering in Asian participants; not definitive evidence of long-term kidney superiority [22] |
T2DM, type 2 diabetes mellitus; CKD, chronic kidney disease; ARTS-DN, Mineralocorticoid Receptor Antagonist Tolerability Study-Diabetic Nephropathy; RAS, renin-angiotensin system; UACR, urinary albumin-to-creatinine ratio; FIDELIO-DKD, Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease; HR, hazard ratio; CI, confidence interval; eGFR, estimated glomerular filtration rate; FIGARO-DKD, Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease; FIDELITY, pooled analysis of FIDELIO-DKD and FIGARO-DKD; CONFIDENCE, Combination Effect of Finerenone and Empagliflozin in Participants with Chronic Kidney Disease and Type 2 Diabetes Using a Urinary Albumin-to-Creatinine Ratio Endpoint.
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| Study | Design/population | Asian representation | Main kidney/albuminuria findings relevant to Asia | Safety message | Evidentiary role/main limitation |
|---|---|---|---|---|---|
| ARTS-DN Japan | Phase IIb, placebo- controlled trial in Japanese patients with T2DM and albuminuric CKD receiving RAS inhibition | 96 Japanese participants | Nominally significant short-term UACR reduction at day 90; supportive early Japanese signal | No major hyperkalemia signal was reported, and serious adverse events were not increased | Early Japanese supportive signal; not part of the phase III evidentiary foundation and not designed for long-term kidney outcomes [ |
| FIDELIO-DKD | Phase III randomized trial in patients with T2DM and CKD receiving optimized RAS inhibition | 5,674 Total participants; included Asian participants | Established finerenone as an evidence-based add-on therapy in T2DM and albuminuric CKD and formed part of the global foundation for later Asian interpretation | Hyperkalemia increased vs. placebo, but discontinuation due to hyperkalemia remained infrequent (2.3% vs. 0.9%) | Global trial; not designed for Asia-specific inference [ |
| FIDELIO-DKD Asia | Post hoc analysis of Asian participants enrolled in FIDELIO-DKD | 1,327 Participants from the Asian region | Kidney composite HR 0.70 (95% CI, 0.56–0.87) for sustained ≥40% decline in eGFR, kidney failure, or kidney-related death; more stringent kidney composite HR 0.73 (95% CI, 0.55–0.97); UACR reduced by 31% at month 4 | Hyperkalemia was more frequent with finerenone, but discontinuation (2.1%) and hospitalization (1.5%) remained uncommon | Regional post hoc subgroup analysis from a single phase III trial; supportive rather than foundational [ |
| FIDELIO-DKD China | Prespecified subgroup analysis of Chinese participants in FIDELIO-DKD | 372 Chinese participants | Kidney composite HR 0.59 (95% CI, 0.39–0.88) for sustained ≥40% decline in eGFR, kidney failure, or kidney-related death; UACR reduced by 26.8% at month 4 | Hyperkalemia-related discontinuation (4.3%) and hospitalization (1.6%) remained uncommon overall | Country-specific subgroup analysis; relatively small sample size [ |
| FIGARO-DKD | Phase III randomized trial in a broader T2DM and CKD population receiving optimized RAS inhibition | 7,437 Total participants; included Asian participants | Extended the finerenone evidence base across a broader CKD spectrum and contributed to the pooled global foundation for Asian interpretation | Hyperkalemia increased vs. placebo, but permanent discontinuation (1.2% vs. 0.4%) and hospitalization (0.6% vs. 0.1%) remained uncommon | Global trial; not designed for Asia-specific inference [ |
| FIGARO-DKD China | Prespecified subgroup analysis of Chinese participants in FIGARO-DKD | 325 Chinese participants | Key secondary kidney outcome HR 0.48 (95% CI, 0.29–0.79); more stringent kidney composite HR 0.40 (95% CI, 0.19–0.83); UACR reduced by 39% at month 4; chronic eGFR slope difference 2.25 mL/min/1.73 m2/year (95% CI, 0.75–3.76) | Investigator-reported hyperkalemia was similar between treatment arms; clinically meaningful hyperkalemia events were uncommon | Country-specific subgroup analysis; exploratory because of limited sample size and event counts [ |
| FIDELITY | Prespecified pooled analysis of FIDELIO-DKD and FIGARO-DKD | 12,990 Total participants | Established the global cardiorenal foundation for finerenone in T2DM and albuminuric CKD | Hyperkalemia increased with finerenone versus placebo, but permanent discontinuation remained infrequent (1.7% vs. 0.6%) | Prespecified pooled analysis forming the global cardiorenal foundation for later Asian interpretation; not a standalone trial [ |
| FIDELITY Asian | Asian subgroup analysis of FIDELITY | 2,858 Asian participants (22.0%); 92.3% enrolled from sites in Asia | Kidney composite HR 0.64 (95% CI, 0.50–0.82) for sustained ≥57% decline in eGFR, kidney failure, or kidney-related death; broader kidney composite HR 0.67 (95% CI, 0.56–0.80) for sustained ≥40% decline in eGFR, kidney failure, or kidney- related death; UACR reduced by 33% at month 4; chronic eGFR slope difference 1.08 mL/min/1.73 m2/year (95% CI, 0.53–1.63) | Hyperkalemia was more frequent with finerenone, but hospitalization and permanent discontinuation remained uncommon under trial conditions | Main pooled Asian interpretive framework; does not establish a uniquely Asian biologic treatment effect [ |
| FIDELITY Asian by baseline kidney function | Asian pooled subanalysis focused on chronic eGFR slope, UACR regression, and safety according to baseline kidney function | 2,858 Asian participants | Chronic eGFR slope difference 1.08 mL/min/1.73 m2/year (95% CI, 0.53–1.63); UACR reduced by 34% at month 4; regression from high or very high albuminuria to normal or mildly increased albuminuria 39.5% vs. 14.8% | Overall adverse events were broadly similar between groups; hyperkalemia remained monitor-dependent | Post hoc pooled subanalysis; interpretation applies within the studied population [ |
| CONFIDENCE | Randomized trial of finerenone, empagliflozin, or simultaneous combination in patients with T2DM, eGFR 30–90 mL/min/1.73 m2, and UACR 100–5,000 mg/g on background RAS inhibition | 818 Randomized participants | In the overall trial population, simultaneous initiation yielded a 29% greater short-term UACR reduction than finerenone alone and a 32% greater reduction than empagliflozin alone | Hyperkalemia leading to drug discontinuation was uncommon; combination therapy did not eliminate potassium risk | UACR-endpoint trial; not a hard kidney outcome trial [ |
| CONFIDENCE Asia | Prespecified participant-level exploratory analysis of Asian participants in CONFIDENCE | 360 Asian participants (46% of trial population) | Combination reduced UACR by 53% at day 180, corresponding to a 30% greater reduction than finerenone alone and a 34% greater reduction than empagliflozin alone | Hyperkalemia remained clinically relevant in Asian participants, including with combination therapy | Supports short-term additive albuminuria lowering in Asian participants; not definitive evidence of long-term kidney superiority [ |
T2DM, type 2 diabetes mellitus; CKD, chronic kidney disease; ARTS-DN, Mineralocorticoid Receptor Antagonist Tolerability Study-Diabetic Nephropathy; RAS, renin-angiotensin system; UACR, urinary albumin-to-creatinine ratio; FIDELIO-DKD, Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease; HR, hazard ratio; CI, confidence interval; eGFR, estimated glomerular filtration rate; FIGARO-DKD, Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease; FIDELITY, pooled analysis of FIDELIO-DKD and FIGARO-DKD; CONFIDENCE, Combination Effect of Finerenone and Empagliflozin in Participants with Chronic Kidney Disease and Type 2 Diabetes Using a Urinary Albumin-to-Creatinine Ratio Endpoint.
