Objective To evaluate the changes in estimated glomerular filtration rate (eGFR), urinary albumin-to-creatinine ratio (UACR) and serum potassium levels in patients with diabetic kidney disease (DKD) treated with finerenone based on real-world data, to identify baseline influencing factors for albuminuria response and serum potassium elevation, and to provide evidence for individualized medication and monitoring in DKD management.

Methods DKD patients who initiated finerenone treatment at Shandong Provincial Hospital Affiliated to Shandong First Medical University from May 2023 to January 2025 were collected. Patients were followed up for 12 months with the date of first prescription as the baseline. Baseline characteristics, concomitant medications, and longitudinal data of eGFR, UACR and serum potassium were collected. Linear mixed-effects models were applied to analyze the trajectories of the indicators. Antialbuminuric response was defined as a ≥30% reduction in UACR from baseline, and A cumulative Stratification aualysis regarding the risk of hyperkalemia was performed.

Results A total of 389 patients were included. After adjusting for confounders, eGFR showed a mild decline (β=-0.166, P=0.046), with an estimated cumulative decrease of approximately 1.99 mL·min^-1·1.73 m^-2 over 12 months. ln(UACR) decreased significantly (β=-0.070, P<0.001), corresponding to a mean monthly reduction of 6.76% in UACR. The response rates at 3, 6 and 12 months were 65.4%, 72.1% and 73.5%, respectively. Patients with stage A3 albuminuria had a more remarkable UACR reduction, while those with concomitant hyperuricemia presented weaker early antiproteinuric response. Serum potassium remained generally stable during treatment, with a hyperkalemia incidence of 2.57%. Baseline eGFR of 25 to <60 mL·min^-¹·1.73 m^-2, stage A3 albuminuria, hyperuricemia, diabetic retinopathy and advanced age were all associated with elevated serum potassium levels. Exploratory risk stratification showed that the incidence of hyperkalemia was 0.3% in patients with 0-1 risk factors and 12.0% in those with ≥2 risk factors.

Conclusion Twelve-month finerenone treatment is associated with sustained albuminuria reduction, mild eGFR decline and an overall manageable potassium-related safety profile. Stratification based on baseline risk factors helps identify populations requiring intensified serum potassium monitoring.

1. KovesdyCP. Epidemiology of chronic kidney disease: an update 2022[J]. Kidney Int Suppl, 2022, 12(1): 7-11. DOI: 10.1016/j.kisu.2021.11.003.

2. WangL, XuX, ZhangM, et al. Prevalence of chronic kidney disease in China: results from the sixth China chronic disease and risk factor surveillance[J]. JAMA Intern Med, 2023, 183(4): 298-310. DOI: 10.1001/jamainternmed.2022.6817.

3. NeuenBL, BelloAK, LevinA, et al. National health policies and strategies for addressing chronic kidney disease: data from the International Society of Nephrology Global Kidney Health Atlas[J]. PLOS Glob Public Health, 2023, 3(1): e0001467. DOI: 10.1371/journal.pgph.0001467.

4. LewisEJ, HunsickerLG, BainRP, et al. The effect of angiotensin-converting-enzyme inhibition on diabetic nephropathy[J]. N Engl J Med, 1993, 329(20): 1456-1462. DOI: 10.1056/NEJM19931111329 2004.

5. BrennerBM, CooperME, de ZeeuwD, et al. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy[J]. N Engl J Med, 2001, 345(12): 861-869. DOI: 10.1056/NEJMoa011161.

6. PerkovicV, JardineMJ, NealB, et al. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy[J]. N Engl J Med, 2019, 380(24): 2295-2306. DOI: 10.1056/NEJMoa1811744.

7. NaamanSC, BakrisGL. Diabetic nephropathy: update on pillars of therapy slowing progression[J]. Diabetes Care, 2023, 46(9): 1574-1586. DOI: 10.2337/dci23-0030.

8. AgarwalR, KolkhofP, BakrisG, et al. Steroidal and non-steroidal mineralocorticoid receptor antagonists in cardiorenal medicine[J]. Eur Heart J, 2021, 42(2): 152-161. DOI: 10.1093/eurheartj/ehaa736.

9. FunderJW. Aldosterone and mineralocorticoid receptors: physiology and pathophysiology[J]. Int J Mol Sci, 2017, 18(5): 1032. DOI: 10.3390/ijms18051032.

10. KintscherU, BakrisGL, KolkhofP. Novel non-steroidal mineralocorticoid receptor antagonists in cardiorenal disease[J]. Br J Pharmacol, 2022, 179(14): 3220-3234. DOI: 10.1111/bph.15747.

11. PatelV, JoharapurkarA, JainM. Role of mineralocorticoid receptor antagonists in kidney diseases[J]. Drug Dev Res, 2021, 82(3): 341-363. DOI: 10.1002/ddr.21760.

12. BakrisGL, AgarwalR, AnkerSD, et al. Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes[J]. N Engl J Med, 2020, 383(23): 2219-2229. DOI: 10.1056/NEJMoa2025845.

13. PittB, FilippatosG, AgarwalR, et al. Cardiovascular events with finerenone in kidney disease and type 2 diabetes[J]. N Engl J Med, 2021, 385(24): 2252-2263. DOI: 10.1056/NEJMoa2110956.

14. AgarwalR, FilippatosG, PittB, et al. Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis[J]. Eur Heart J, 2022, 43(6): 474-484. DOI: 10.1093/eurheartj/ehab777.

15. Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2024 clinical practice guideline for the evaluation and management of chronic kidney disease[J]. Kidney Int, 2024, 105(4S): S117-S314. DOI: 10.1016/j.kint.2023.10.018.

16. McDonaghTA, MetraM, AdamoM, et al. 2023 focused update of the 2021 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure[J]. Eur Heart J, 2023, 44(37): 3627-3639. DOI: 10.1093/eurheartj/ehad195.

17. 中华医学会糖尿病学分会. 中国糖尿病肾脏病防治指南(2024年版)[J]. 中华糖尿病杂志, 2024, 16(6): 401-420.Chinese Diabetes Society. Chinese guideline for the prevention and treatment of diabetic kidney disease (2024 Edition)[J]. Chinese Journal of Diabetes, 2024, 16(6): 401-420. DOI: 10.3760/cma.j.cn115791-20241203-00705.

18. American Diabetes Association Professional Practice Committee.11. Chronic kidney disease and risk management: standards of care in diabetes-2025[J]. Diabetes Care, 2025, 48(Suppl 1): S239-S251. DOI: 10.2337/dc25-S011.

19. FilippatosG, BakrisGL, PittB, et al. Hyperkalemia risk with finerenone: results from the FIDELIO-DKD trial[J]. J Am Soc Nephrol, 2022, 33(1): 225-237. DOI: 10.1681/ASN.2021070942.

20. NeuenBL, HeerspinkHJL, VartP, et al. Estimated lifetime cardiovascular, kidney, and mortality benefits of combination treatment with SGLT2 inhibitors, GLP-1 receptor agonists, and nonsteroidal MRA compared with conventional care in patients with type 2 diabetes and albuminuria[J]. Circulation, 2024, 149(6): 450-462. DOI: 10.1161/CIRCULATIONAHA.123.067584.

21. CoreshJ, HeerspinkHJL, SangY, et al. Change in albuminuria and subsequent risk of end-stage kidney disease: an individual participant-level consortium meta-analysis of observational studies[J]. Lancet Diabetes Endocrinol, 2019, 7(2): 115-127. DOI: 10.1016/S2213-8587(18)30313-9.

22. GreenJB, MottlAK, BakrisGL, et al. Design of the Combination effect of finerenone and empagliflozin in participants with chronic kidney disease and type 2 diabetes using a UACR Endpoint study (CONFIDENCE)[J]. Nephrol Dial Transplant, 2023, 38(4): 894-903. DOI: 10.1093/ndt/gfac198.

23. NeuenBL, OshimaM, AgarwalR, et al. Sodium-glucose cotransporter 2 inhibitors and risk of hyperkalemia in people with type 2 diabetes: a meta-analysis of individual participant data from randomized, controlled trials[J]. Circulation, 2022, 145(19): 1460-1470. DOI: 10.1161/CIRCULATIONAHA.121.057736.

24. TerkerAS, EllisonDH. Renal mineralocorticoid receptor and electrolyte homeostasis[J]. Am J Physiol Regul Integr Comp Physiol, 2015, 309(9): R1068-R1070. DOI: 10.1152/ajpregu.00135.2015.

25. 郭美玲, 柴克燕, 刘蕴资, 等. 数据挖掘方法在真实世界研究中的应用进展[J]. 药物流行病学杂志, 2026, 35(4): 451-461.GuoML, ChaiKY, LiuYZ, et al. Advances in the application of data mining methods in real-world studies[J]. Chinese Journal of Pharmacoepidemiology, 2026, 35(4): 451-461. DOI: 10.12173/j.issn.1005-0698.202511032.