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Review
Pharmacotherapy Finerenone in Asian Patients with Type 2 Diabetes Mellitus and Albuminuric Chronic Kidney Disease: From Evidence to Implementation
Masayuki Yamanouchi1,2,3,4,5orcid, Kengo Furuichi4orcid, Takashi Wada5orcid
Diabetes & Metabolism Journal 2026;50(4):629-640.
DOI: https://doi.org/10.4093/dmj.2026.0306
Published online: July 1, 2026
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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

corresp_icon Corresponding author: Masayuki Yamanouchi orcid Nephrology Center, Toranomon Hospital, 2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, Japan, E-mail: m.yamanouchi@toranomon.gr.jp
• Received: March 25, 2026   • Accepted: June 23, 2026

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.

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  • Finerenone reduces kidney and cardiovascular risk in patients with type 2 diabetes mellitus (T2DM) and albuminuric chronic kidney disease (CKD). Recent Asian subgroup, pooled, combination-therapy, Asian versus non-Asian, and real-world analyses have expanded the evidence base relevant to Asian practice. These data support the consistency of finerenone efficacy and safety in Asian patients and do not support withholding treatment on the basis of Asian ethnicity alone. However, the central question in Asia is shifting from whether finerenone is effective to how eligible patients can be identified, treated, monitored, and continued on therapy in routine care. This review summarizes Asian evidence from the FIDELIO-DKD, FIGARO-DKD, FIDELITY, and CONFIDENCE programs and emerging Asian real-world data. Focus is placed on persistent albuminuric risk, potassium monitoring, treatment sequencing with sodium-glucose cotransporter 2 inhibitors, and implementation feasibility across heterogeneous health-care systems. Finerenone should be considered an evidence-based add-on therapy when baseline potassium and kidney function are appropriate and early laboratory monitoring can be delivered. Simultaneous or early combination therapy may be appropriate in selected high-risk patients, but is not a universal default strategy. The practical priority is to strengthen CKD phenotyping, albuminuria testing, structured potassium monitoring, and care pathways that support sustained use of trial-proven therapy.
• Asian evidence supports finerenone efficacy and safety.
• Asian ethnicity alone should not limit finerenone treatment.
• Persistent albuminuric risk should guide finerenone use.
• Early finerenone–SGLT2 inhibitor combination may suit selected high-risk patients.
• Structured potassium monitoring supports safe finerenone use.
The burden of type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) is rising rapidly in many Asian health-care settings, making implementation of kidney-protective therapy a major clinical priority in the region [1,2]. The number of adults with diabetes in the South-East Asia Region is projected to increase by 73%, reaching 185 million by 2050, while the Western Pacific Region already accounts for 37% of adults living with diabetes worldwide and is projected to reach 254 million by 2050 [1]. CKD burden is also increasing across Asia; in an analysis of 49 Asian countries, the absolute numbers of CKD incident cases, deaths, prevalent cases, and disability-adjusted life years increased by 100% or more in nearly all countries between 1990 and 2019 [2]. CKD develops in up to approximately 40% of patients with T2DM and the coexistence of T2DM and CKD is associated with substantially higher risks of kidney failure, cardiovascular events, and premature death [35]. These trends underscore the need not only to recognize CKD in patients with T2DM, but also to phenotype kidney risk by albuminuria and estimated glomerular filtration rate (eGFR) so that evidence-based kidney-protective therapies can be delivered to appropriate patients [6].
Landmark CKD outcome trials of sodium-glucose cotransporter 2 (SGLT2) inhibitors, including Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE), Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD), and The Study of Heart and Kidney Protection With Empagliflozin (EMPA-KIDNEY), have established SGLT2 inhibition as foundational therapy for reducing cardiorenal risk in patients with CKD, including those with T2DM and albuminuric CKD [79]. However, clinically meaningful residual cardiorenal risk remains despite these advances, and post hoc analyses of SGLT2 inhibitor trials have shown that residual albuminuria during treatment remains associated with subsequent kidney and cardiovascular events [1012]. This supports the need for additional protective pathways and add-on therapies. Against this background, finerenone has emerged as an important evidence-based add-on therapy for patients with T2DM and albuminuric CKD [1315].
In Asia, the practical question is increasingly shifting from whether finerenone is effective to how eligible patients can be identified and treated safely in routine care. Clinical uptake may be influenced by heterogeneous monitoring capacity, access to albuminuria testing, reimbursement, and the ability of health systems to implement evidence-supported care [16]. Recent Asian analyses from the Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease (FIDELIO-DKD), Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD), pooled analysis of FIDELIO-DKD and FIGARO-DKD (FIDELITY), and Combination Effect of Finerenone and Empagliflozin in Participants with Chronic Kidney Disease and Type 2 Diabetes Using a Urinary Albumin-to-Creatinine Ratio Endpoint (CONFIDENCE) programs have expanded the evidence base relevant to finerenone use in Asian patients [1722]. This review summarizes these data and examines how they should inform patient selection, potassium monitoring, and the positioning of finerenone alone or in combination with SGLT2 inhibitors in Asian practice.
The pivotal phase III program has established finerenone as an evidence-based add-on therapy for patients with T2DM and albuminuric CKD receiving optimized renin-angiotensin system inhibition [1315], and recent Asian analyses have supported the consistency of its efficacy and safety in Asian participants [1722]. The central question has therefore shifted from whether finerenone works in Asia to how eligible patients can be identified, monitored, and sustainably treated in routine care.
This review focuses on that interface. It does not propose a separate ethnicity-based treatment rule; rather, it integrates Asian subgroup, pooled, combination-therapy, and real-world data to address three practical decisions: identifying patients with persistent albuminuric risk, assessing the feasibility of potassium monitoring, and positioning finerenone relative to SGLT2 inhibitor therapy. Across Asia, barriers to implementation may include incomplete CKD phenotyping by albuminuria, inadequate post-initiation laboratory follow-up, and health-system heterogeneity in access to monitoring and reimbursement [16].
In patients with T2DM and albuminuric CKD, substantial residual cardiorenal risk remains despite major advances in standard-of-care therapy, including renin-angiotensin system inhibition and SGLT2 inhibition. Landmark CKD outcome trials of canagliflozin, dapagliflozin, and empagliflozin have established SGLT2 inhibition as foundational therapy [79]. However, post hoc analyses of SGLT2 inhibitor trials have shown that residual albuminuria during treatment remains strongly associated with subsequent kidney and cardiovascular events, even among patients receiving SGLT2 inhibitors [1012]. Thus, persistent albuminuria is not merely a residual laboratory abnormality, but a marker of ongoing treatable cardiorenal risk. This residual albuminuric risk supports the need for additional protective pathways beyond hemodynamic mechanisms alone.
Mineralocorticoid receptor overactivation is one biologically plausible contributor to this residual risk [2325]. Beyond its effects on sodium retention and blood pressure, mineralocorticoid receptor activation can promote kidney and vascular injury through proinflammatory and profibrotic signaling in multiple cell types [2325]. Finerenone, a selective nonsteroidal mineralocorticoid receptor antagonist, targets these pathways and is therefore best understood not simply as an additional antiproteinuric agent, but as a mechanism-based intervention aimed at residual inflammatory and fibrotic risk [26].
For the present review, the purpose of discussing mechanism is not to provide a comprehensive mechanistic review. Rather, it is to explain why finerenone deserves consideration as part of multidrug cardiorenal protection in patients with T2DM and albuminuric CKD, particularly when residual albuminuric risk persists despite contemporary foundational care. This mechanistic rationale also helps frame the clinical question addressed in later sections: not whether finerenone should replace existing therapies, but how it should be positioned alongside renin-angiotensin system inhibition, SGLT2 inhibitors, and monitoring-based risk management in routine Asian practice.
The foundation of the current finerenone evidence base in T2DM and albuminuric CKD is the FIDELIO-DKD and FIGARO-DKD phase III trials and their prespecified pooled analysis, FIDELITY [1315]. These trials established finerenone as an evidence-based add-on therapy for patients with T2DM and albuminuric CKD receiving optimized renin-angiotensin system inhibition, at a time when baseline use of SGLT2 inhibitors was limited.
FIDELIO-DKD enrolled patients with more advanced albuminuric CKD and demonstrated that finerenone reduced the risk of kidney disease progression [13]. FIGARO-DKD included a broader CKD population with greater representation of earlier CKD stages and demonstrated cardiovascular benefit, with supportive kidney findings [14]. FIDELITY integrated these complementary trial populations and provided the most comprehensive estimate of finerenone effects on cardiovascular and kidney composite outcomes, with an expected increase in hyperkalemia that infrequently led to permanent discontinuation [15].
Asian analyses add important clinical context to the global finerenone evidence by clarifying how efficacy and safety should be interpreted in Asian patients with T2DM and albuminuric CKD. The key Asian subgroup, pooled, country-specific, and combination-therapy studies relevant to finerenone use in this population are summarized in Table 1.
An earlier Japanese phase IIb trial, Mineralocorticoid Receptor Antagonist Tolerability Study-Diabetic Nephropathy Japan (ARTS-DN Japan), provided an initial short-term signal that finerenone could reduce albuminuria in Japanese patients with T2DM and albuminuric CKD receiving renin-angiotensin system (RAS) inhibition, without a major hyperkalemia signal [27]. However, because this study was small, short-term, and not designed to evaluate kidney or cardiovascular outcomes, it should be viewed as supportive background evidence rather than part of the phase III outcome-trial foundation.
Regional and country-specific analyses from the phase III program first showed that the kidney benefits and albuminuria-lowering effects of finerenone were not limited to the global aggregate population. In FIDELIO-DKD Asia, finerenone reduced the risk of the kidney composite outcome based on sustained ≥40% decline in eGFR, kidney failure, or kidney-related death [17]. In the China subgroup of FIDELIO-DKD, finerenone reduced urinary albumin-to-creatinine ratio (UACR) at month 4 and showed directionally consistent kidney and cardiovascular findings [18]. In the China subgroup of FIGARO-DKD, finerenone reduced UACR and was associated with favorable kidney outcome estimates [19]. These analyses are clinically useful because they support the applicability of the phase III trial findings to Asian populations, while remaining subgroup or regional analyses within larger global trials.
The FIDELITY Asian analysis then provided the most important pooled Asian dataset. Of 12,990 participants in FIDELITY, 2,858 self-identified as Asian, most of whom were enrolled from sites in Asia [20]. This analysis showed that Asian participants were not merely a geographic subset, but a clinically meaningful population in whom efficacy and safety could be interpreted directly [20]. In Asian participants, finerenone reduced kidney composite outcomes based on sustained ≥57% or ≥40% decline in eGFR, kidney failure, or kidney-related death [20]. Finerenone also reduced UACR at month 4 and attenuated chronic eGFR decline in Asian participants [20].
The subsequent FIDELITY Asian analysis by baseline kidney function made the pooled Asian evidence more clinically useful [21]. It reinforced that both albuminuria and kidney function should inform risk interpretation and treatment positioning in Asian patients. Finerenone reduced UACR, attenuated chronic eGFR decline, and increased regression to normal or mildly increased albuminuria across clinically relevant kidney function strata [21]. These findings support the use of albuminuria not merely as a descriptive biomarker, but as a practical tool for identifying persistent treatable risk.
Taken together, Asian analyses support the consistency and applicability of finerenone evidence in Asian patients, but they should not be overinterpreted as proving a uniquely Asian treatment effect. Their contribution lies in convergent interpretation within the phase III framework: they help clarify which Asian patients resemble the trial populations, how residual albuminuric risk should be recognized, and why potassium monitoring and treatment feasibility are central to implementation. The next section therefore focuses on the direct Asian versus non-Asian comparison of efficacy and safety, before turning to combination therapy, monitoring, and real-world implementation.
Asian versus non-Asian comparisons should be interpreted as tests of clinical consistency rather than as a basis for separate ethnicity-based treatment rules. In FIDELITY, finerenone showed no evidence of diminished efficacy in Asian participants compared with non-Asian participants (Fig. 1) [20]. The cardiovascular composite outcome showed broadly similar treatment effects in Asian and non-Asian participants. For kidney composite outcomes, the point estimates were more favorable in Asian participants, with statistically significant treatment-by-subpopulation interactions for both the ≥57% and ≥40% eGFR composite kidney outcomes [20]. These findings support the efficacy of finerenone in Asian patients, but they should not be overinterpreted as evidence of a uniquely Asian biologic response because the analyses were post hoc, ethnicity was not randomized, and baseline risk profiles differed between subpopulations.
The safety findings point in the same direction, although potassium requires specific attention. Investigator-reported hyperkalemia was more frequent in Asian participants, yet laboratory-defined serum potassium elevations and clinically consequential hyperkalemia events were broadly comparable between Asian and non-Asian participants receiving finerenone (Fig. 1) [20]. Hyperkalemia leading to permanent discontinuation or hospitalization remained uncommon in both subpopulations [20]. Thus, potassium risk is clinically relevant and monitor-dependent, but the available evidence does not support withholding finerenone on the basis of Asian ethnicity alone.
The CONFIDENCE Asia analysis provides complementary evidence for combination therapy [22]. In Asian participants, simultaneous initiation of finerenone and empagliflozin produced a 30% greater UACR reduction than finerenone alone and a 34% greater reduction than empagliflozin alone at day 180; the corresponding differences in Europe/North America were similar at 29% and 31%, respectively [22]. These estimates were derived from between-group comparisons of UACR change based on least-squares mean pairwise ratios. However, because CONFIDENCE was a 180-day UACR-endpoint trial, these data support consistency of short-term albuminuria lowering rather than establishing long-term kidney or cardiovascular outcome benefits of simultaneous initiation in Asian patients.
Taken together, Asian versus non-Asian comparisons do not support a separate therapeutic principle based on ethnicity. Rather, they suggest that the more important clinical task in Asia is to identify patients with persistent albuminuric risk, confirm that potassium and kidney function can be monitored, and avoid unnecessary delay in initiating or continuing finerenone in patients who remain eligible for treatment.
Building on the Asian UACR findings summarized above, CONFIDENCE supports simultaneous initiation of finerenone and an SGLT2 inhibitor as a short-term albuminuria-lowering strategy in patients with T2DM and albuminuric CKD [28]. Simultaneous or early combination therapy should therefore be considered a reasonable option for selected higher-risk patients with persistent or substantial albuminuria, particularly A3 albuminuria (UACR >300 mg/g) or clearly persistent UACR elevation, appropriate baseline serum potassium and eGFR, and capacity for early laboratory monitoring, rather than a universal default strategy.
These findings reinforce the need to measure UACR and act on persistent albuminuric risk in Asian practice, rather than relying on eGFR alone. They also support targeting complementary pathways through SGLT2 inhibition and mineralocorticoid receptor blockade.
The feasibility of simultaneous initiation will differ across Asian settings. Where UACR testing and early potassium reassessment are routinely available, simultaneous initiation may be realistic for selected high-risk patients. Where monitoring infrastructure is limited, reimbursement or access barriers exist, or specialist follow-up is difficult, sequential initiation after SGLT2 inhibitor therapy remains appropriate. Thus, CONFIDENCE supports early combination therapy as an evidence-based strategy for short-term albuminuria lowering, while leaving the timing of initiation to be individualized according to risk, access, and monitoring capacity.
For clinicians considering finerenone in Asian patients with T2DM and albuminuric CKD, the main practical safety concern is hyperkalemia. The FIDELITY Asian analysis provides the key numerical context: among Asian participants, hyperkalemia leading to hospitalization occurred in 1.1% receiving finerenone versus <0.1% receiving placebo, and hyperkalemia leading to permanent discontinuation in 1.5% versus 0.6%, respectively [20]. Risk was highest in participants with lower baseline eGFR. In recent Japanese real-world data, the largest potassium rise occurred during the first 1–2 months after initiation [29]. Potassium risk is therefore real and monitor-dependent, but not prohibitive, supporting proactive monitoring rather than avoidance.
Combination therapy with an SGLT2 inhibitor does not eliminate this issue. In the CONFIDENCE Asia analysis, the combination of finerenone and empagliflozin was still associated with hyperkalemia and laboratory-assessed potassium elevations, indicating that SGLT2 inhibitor co-administration should not be viewed as a substitute for potassium monitoring [30]. Finerenone should therefore be used when baseline potassium and kidney function are appropriate, early laboratory reassessment can be completed, and reversible contributors to hyperkalemia have been reviewed. Temporary interruption and reinitiation after potassium normalization are reasonable approaches to managing transient elevations while preserving the opportunity for sustained kidney protection.
Fig. 2 summarizes a practical framework for finerenone implementation in Asian clinical practice. Finerenone should be considered in patients with T2DM and persistent albuminuric CKD despite optimized standard therapy, and UACR measurement is essential for eligibility assessment. Patients without meaningful albuminuria are less directly represented in the outcome trials. Before initiation, clinicians should confirm acceptable baseline serum potassium and kidney function within the locally approved range, and review reversible contributors to hyperkalemia, including potassium supplements, nonsteroidal anti-inflammatory drugs, high dietary potassium intake, and dehydration.
Treatment positioning should follow the principles discussed in the section on combination therapy: finerenone may be introduced sequentially after SGLT2 inhibitor initiation when albuminuria persists, or considered earlier in selected high-risk patients with A3 albuminuria when monitoring is feasible. Whichever sequence is chosen, serum potassium and kidney function should be assessed before initiation, reassessed early after initiation (for example, within 4 weeks), and monitored periodically thereafter; mild elevations should prompt review of reversible factors before permanent discontinuation is considered.
Implementation should also be viewed as a system-level process. In settings where UACR testing and potassium monitoring are reliably available, including Korea, where contemporary diabetes guidelines increasingly emphasize cardiorenal risk reduction [31], finerenone can be incorporated into a residual-risk management pathway. In settings where these components are inconsistent, the priority is to strengthen CKD phenotyping and monitoring infrastructure before or alongside treatment initiation. The goal is not a separate Asian treatment rule, but to ensure that evidence-supported therapy reaches appropriate patients safely and sustainably across heterogeneous Asian health-care systems.
Real-world evidence does not replace randomized evidence, but it addresses practical questions trials were not designed to answer: whether finerenone is initiated and continued in routine care, whether potassium-related discontinuation is common, and whether monitoring pathways are deliverable. Japanese observational studies reported attenuation of eGFR decline and albuminuria reductions after finerenone initiation, without frequent severe hyperkalemia or potassium-related treatment failure; these uncontrolled studies provide implementation signals, not causal evidence [3234]. A Chinese single-center study of 42 patients found that 68.4% achieved ≥30% UACR reduction over 6 months; discontinuation due to hyperkalemia and acute kidney injury each occurred in one patient [35].
Larger and more safety-focused real-world datasets provide complementary information. The FinerenOne mUltidatabase NeTwork for evidence generAtIoN (FOUNTAIN) database study in Japan showed low early hyperkalemia incidence and no hyperkalemia-related hospitalizations during short-term follow-up, with finerenone frequently co-prescribed with SGLT2 inhibitors [36]. A Japanese single-center cohort of 280 patients found incident hyperkalemia (≥5.5 mEq/L) in 38 patients and severe hyperkalemia (≥6.0 mEq/L) in five, with the largest potassium rise during the first 1–2 months; patients with reduced kidney function or higher baseline potassium maintained higher potassium levels during follow-up [29]. Taken together, these data support the feasibility of finerenone use in monitored Asian settings while confirming the need for early potassium monitoring.
Korean real-world evidence remains an important gap. The ongoing observational FINE-REAL Korea study, an observational study of finerenone use in routine clinical care in South Korea, is expected to provide local data on patient characteristics, initiation and discontinuation patterns, concomitant therapies, and hyperkalemia-related outcomes [37]. Until such data become available, Korean implementation should be guided by the global and Asian trial evidence and contemporary Korean diabetes guidelines [31]. The limitations of all existing real-world data must remain explicit: observational studies are vulnerable to selection bias, confounding by indication, and center-level differences in monitoring intensity; they cannot prove long-term comparative effectiveness, define optimal sequencing, or be generalized uncritically across Asia.
Despite the growing evidence base, several gaps remain. Asian participants should not be treated as a homogeneous population: Asia includes countries with substantial differences in CKD epidemiology, dietary potassium intake, albuminuria testing access, reimbursement, and specialist care. Existing Asian analyses support the clinical consistency of finerenone efficacy and safety within studied populations, but they do not fully define implementation across diverse Asian health-care systems. For example, CONFIDENCE Asia included participants from India, Japan, the Republic of Korea, and Taiwan, whereas mainland China and many Southeast Asian countries were not represented [22]. Available pharmacokinetic data do not support clinically meaningful ethnicity-based differences in finerenone exposure that would justify separate dosing rules [38], but whether dietary potassium intake, concomitant diuretic use, potassium binder availability, frailty, and access to timely laboratory reassessment modify hyperkalemia risk in Asian practice remains uncertain.
The optimal timing of finerenone initiation relative to SGLT2 inhibitor therapy also remains unresolved. CONFIDENCE established that simultaneous initiation provides greater short-term UACR reduction, but was not designed to determine whether it improves long-term kidney or cardiovascular outcomes compared with sequential initiation. Evidence on treatment persistence, dose adjustment, and unnecessary discontinuation in routine Asian care is also limited. Future implementation studies should evaluate UACR testing rates, prescribing patterns, monitoring adherence, and reimbursement barriers to distinguish pharmacologic limitations from health-system gaps. The expanding finerenone evidence base, including Finerenone Efficacy and Safety in Chronic Kidney Disease and Type One Diabetes (FINE-ONE) in type 1 diabetes mellitus and CKD [39] and Finerenone in Non-Diabetic CKD (FIND-CKD) in non-diabetic CKD [40], should further motivate Asian studies that address albuminuria phenotyping, potassium monitoring, and treatment persistence across diverse settings.
Recent Asian subgroup, pooled, combination-therapy, and real-world analyses have strengthened the evidence base for finerenone in patients with T2DM and albuminuric CKD. Overall, these data support the consistency of finerenone efficacy and safety in Asian patients and do not support withholding finerenone on the basis of Asian ethnicity alone. At the same time, the available evidence does not justify a separate ethnicity-based treatment rule or a universal default strategy for simultaneous combination therapy.
The more important question for Asian practice is how to translate trial-proven therapy into routine care. Finerenone should be considered for patients with persistent albuminuric risk when baseline potassium and kidney function are appropriate and early laboratory monitoring can be delivered. SGLT2 inhibitors remain foundational therapy, and finerenone should be positioned as an evidence-based add-on therapy that may be introduced sequentially or, in selected high-risk patients, considered earlier as part of combination treatment. The timing of initiation should be individualized according to albuminuric risk, potassium risk, monitoring feasibility, tolerability, cost, and reimbursement.
Thus, the practical challenge in Asia is not simply to determine whether finerenone works, but to ensure that eligible patients are identified, treated, monitored, and continued on therapy safely. Wider use will require reliable UACR testing, structured potassium monitoring, appropriate management of reversible hyperkalemia risk factors, and health-system pathways that support sustained treatment. Future research should clarify optimal sequencing, long-term outcomes of combination therapy, real-world treatment persistence, and intra-Asian differences in implementation. Finerenone is therefore best viewed not as a region-specific therapy, but as a trial-proven therapy whose benefit in Asia will depend on accurate CKD phenotyping, careful monitoring, and practical systems for sustained use.

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

Fig. 1
Asian versus non-Asian comparison of efficacy and safety in pooled analysis of FIDELIO-DKD and FIGARO-DKD (FIDELITY). (A) Treatment effects of finerenone versus placebo on cardiovascular (CV) and kidney outcomes in the Asian and non-Asian subpopulations of FIDELITY. Hazard ratios (HRs) and 95% confidence intervals (CIs) are shown for the composite CV outcome and composite kidney outcomes defined by kidney failure, sustained ≥57% or ≥40% decline in estimated glomerular filtration rate (eGFR) from baseline, or kidney-related death. Interaction P values compare treatment effects between Asian and non-Asian subpopulations. (B) Selected hyperkalemia-related safety outcomes among finerenone-treated participants in Asian and non-Asian subpopulations. Outcomes include serum potassium >5.5 mmol/L, serum potassium >6.0 mmol/L, hyperkalemia leading to permanent treatment discontinuation, and hyperkalemia leading to hospitalization. The figure was constructed from published data reported in the FIDELITY Asian analysis.
dmj-2026-0306f1.jpg
Fig. 2
Practical implementation framework for finerenone use in Asian patients with type 2 diabetes mellitus (T2DM) and albuminuric chronic kidney disease (CKD). This framework summarizes a practical approach to CKD phenotyping, finerenone candidacy assessment, potassium-monitoring feasibility, treatment positioning, and longitudinal follow-up in Asian clinical practice. It assumes optimized standard therapy, including renin-angiotensin system (RAS) inhibitor therapy when tolerated and sodium-glucose cotransporter 2 (SGLT2) inhibitor therapy when appropriate. Finerenone may be introduced sequentially for persistent albuminuric risk, whereas early combination with an SGLT2 inhibitor may be considered in selected higher-risk patients when potassium, kidney function, and follow-up capacity allow appropriate monitoring. The figure is intended as an implementation framework rather than a fixed treatment algorithm, and treatment decisions should be individualized according to albuminuric risk, potassium risk, estimated glomerular filtration rate (eGFR), tolerability, local approval, reimbursement, and monitoring capacity. UACR, urinary albumin-to-creatinine ratio.
dmj-2026-0306f2.jpg
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Table 1
Key global, Asian subgroup, pooled, and combination-therapy studies relevant to finerenone use in patients with T2DM and albuminuric CKD
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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        Finerenone in Asian Patients with Type 2 Diabetes Mellitus and Albuminuric Chronic Kidney Disease: From Evidence to Implementation
        Diabetes Metab J. 2026;50(4):629-640.   Published online July 1, 2026
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      Finerenone in Asian Patients with Type 2 Diabetes Mellitus and Albuminuric Chronic Kidney Disease: From Evidence to Implementation
      Image Image Image
      Fig. 1 Asian versus non-Asian comparison of efficacy and safety in pooled analysis of FIDELIO-DKD and FIGARO-DKD (FIDELITY). (A) Treatment effects of finerenone versus placebo on cardiovascular (CV) and kidney outcomes in the Asian and non-Asian subpopulations of FIDELITY. Hazard ratios (HRs) and 95% confidence intervals (CIs) are shown for the composite CV outcome and composite kidney outcomes defined by kidney failure, sustained ≥57% or ≥40% decline in estimated glomerular filtration rate (eGFR) from baseline, or kidney-related death. Interaction P values compare treatment effects between Asian and non-Asian subpopulations. (B) Selected hyperkalemia-related safety outcomes among finerenone-treated participants in Asian and non-Asian subpopulations. Outcomes include serum potassium >5.5 mmol/L, serum potassium >6.0 mmol/L, hyperkalemia leading to permanent treatment discontinuation, and hyperkalemia leading to hospitalization. The figure was constructed from published data reported in the FIDELITY Asian analysis.
      Fig. 2 Practical implementation framework for finerenone use in Asian patients with type 2 diabetes mellitus (T2DM) and albuminuric chronic kidney disease (CKD). This framework summarizes a practical approach to CKD phenotyping, finerenone candidacy assessment, potassium-monitoring feasibility, treatment positioning, and longitudinal follow-up in Asian clinical practice. It assumes optimized standard therapy, including renin-angiotensin system (RAS) inhibitor therapy when tolerated and sodium-glucose cotransporter 2 (SGLT2) inhibitor therapy when appropriate. Finerenone may be introduced sequentially for persistent albuminuric risk, whereas early combination with an SGLT2 inhibitor may be considered in selected higher-risk patients when potassium, kidney function, and follow-up capacity allow appropriate monitoring. The figure is intended as an implementation framework rather than a fixed treatment algorithm, and treatment decisions should be individualized according to albuminuric risk, potassium risk, estimated glomerular filtration rate (eGFR), tolerability, local approval, reimbursement, and monitoring capacity. UACR, urinary albumin-to-creatinine ratio.
      Graphical abstract
      Finerenone in Asian Patients with Type 2 Diabetes Mellitus and Albuminuric Chronic Kidney Disease: From Evidence to Implementation
      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]
      Table 1 Key global, Asian subgroup, pooled, and combination-therapy studies relevant to finerenone use in patients with T2DM and albuminuric CKD

      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.

      Yamanouchi M, Furuichi K, Wada T. Finerenone in Asian Patients with Type 2 Diabetes Mellitus and Albuminuric Chronic Kidney Disease: From Evidence to Implementation. Diabetes Metab J. 2026;50(4):629-640.
      Received: Mar 25, 2026; Accepted: Jun 23, 2026
      DOI: https://doi.org/10.4093/dmj.2026.0306.

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