Finerenone as a therapeutic option for managing chronic kidney disease (CKD) linked to type 2 diabetes (T2D) and his other potential use. A summary of current research findings
DOI:
https://doi.org/10.12775/QS.2025.43.62411Keywords
finerenone, chronic kidney disease (CKD), type 2 diabetes (T2D), diabetic kidney disease (DKD), mineralocorticoid receptor (MR)Abstract
Introduction: Chronic kidney disease (CKD) is a common, often late-diagnosed and progressive condition associated with increased morbidity and mortality, mainly due to elevated cardiovascular risk. Diabetes is the one of the leading causes of CKD. Due to the significant role that excessive mineralocorticoid receptor (MR) activation plays in the development of diabetic kidney disease (DKD), new therapies that target this pathway, are being investigated. Finerenone is a non-steroidal selective antagonist that reduces inflammation and fibrosis by blocking MR overactivity in the kidneys, heart, and blood vessels. Materials and Methods: This review is based on a comprehensive analysis of studies on the use of finerenone in patients with CKD and type 2 diabetes (T2D). Additionally, this article explores the potential applications of finerenone. The review was developed using a PubMed database and ClinicalTrials.gov. Results: The results of the FIDELIO-DKD and FIGARO-DKD trials, as well as the FIDELITY pooled analysis, showed that finerenone significantly improved renal and cardiovascular outcomes. They also showed that although hyperkalemia is a major adverse effect of finerenone treatment, the therapy is safe with appropiate monitoring and dose adjustment. In addition, its possible beneficial effects are in non-diabetic CKD, heart failure with preserved (HFpEF) and mildly reduced (HFmrEF) ejection fraction, advanced of CKD with lower estimated glomerular filtration rate (eGFR), and diabetic retinopathy. Conclusion: Clinical studies have confirmed that finerenone is a valuable addition to nephroprotective and cardioprotective strategies in the management of CKD associated with T2D, as reflected in latest clinical guidelines. Its safety profile is generally acceptable. Ongoing clinical trials will help clarify whether the approved indications for finerenone can be extended to non-diabetic CKD or additional clinical settings.
References
[1] Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group (2024). KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney international, 105(4S), S117–S314. https://doi.org/10.1016/j.kint.2023.10.018
[2] Jager, K. J., Kovesdy, C., Langham, R., Rosenberg, M., Jha, V., & Zoccali, C. (2019). A single number for advocacy and communication-worldwide more than 850 million individuals have kidney diseases. Kidney international, 96(5), 1048–1050. https://doi.org/10.1016/j.kint.2019.07.012
[3] Zdrojewski, Ł., Zdrojewski, T., Rutkowski, M., Bandosz, P., Król, E., Wyrzykowski, B., & Rutkowski, B. (2016). Prevalence of chronic kidney disease in a representative sample of the Polish population: results of the NATPOL 2011 survey. Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 31(3), 433–439. https://doi.org/10.1093/ndt/gfv369
[4] Webster, A. C., Nagler, E. V., Morton, R. L., & Masson, P. (2017). Chronic Kidney Disease. Lancet (London, England), 389(10075), 1238–1252. https://doi.org/10.1016/S0140-6736(16)32064-5
[5] Charles, C., & Ferris, A. H. (2020). Chronic Kidney Disease. Primary care, 47(4), 585–595. https://doi.org/10.1016/j.pop.2020.08.001
[6] Jankowski, J., Floege, J., Fliser, D., Böhm, M., & Marx, N. (2021). Cardiovascular Disease in Chronic Kidney Disease: Pathophysiological Insights and Therapeutic Options. Circulation, 143(11), 1157–1172. https://doi.org/10.1161/CIRCULATIONAHA.120.050686
[7] Inker, L. A., Eneanya, N. D., Coresh, J., Tighiouart, H., Wang, D., Sang, Y., Crews, D. C., Doria, A., Estrella, M. M., Froissart, M., Grams, M. E., Greene, T., Grubb, A., Gudnason, V., Gutiérrez, O. M., Kalil, R., Karger, A. B., Mauer, M., Navis, G., Nelson, R. G., … Chronic Kidney Disease Epidemiology Collaboration (2021). New Creatinine- and Cystatin C-Based Equations to Estimate GFR without Race. The New England journal of medicine, 385(19), 1737–1749. https://doi.org/10.1056/NEJMoa2102953
[8] Writing Group for the CKD Prognosis Consortium, Grams, M. E., Coresh, J., Matsushita, K., Ballew, S. H., Sang, Y., Surapaneni, A., Alencar de Pinho, N., Anderson, A., Appel, L. J., Ärnlöv, J., Azizi, F., Bansal, N., Bell, S., Bilo, H. J. G., Brunskill, N. J., Carrero, J. J., Chadban, S., Chalmers, J., Chen, J., … Gansevoort, R. T. (2023). Estimated Glomerular Filtration Rate, Albuminuria, and Adverse Outcomes: An Individual-Participant Data Meta-Analysis. JAMA, 330(13), 1266–1277. https://doi.org/10.1001/jama.2023.17002
[9] Levey, A. S., Grams, M. E., & Inker, L. A. (2022). Uses of GFR and Albuminuria Level in Acute and Chronic Kidney Disease. The New England journal of medicine, 386(22), 2120–2128. https://doi.org/10.1056/NEJMra2201153
[10] Kalantar-Zadeh, K., Jafar, T. H., Nitsch, D., Neuen, B. L., & Perkovic, V. (2021). Chronic kidney disease. Lancet (London, England), 398(10302), 786–802. https://doi.org/10.1016/S0140-6736(21)00519-5
[11] American Diabetes Association Professional Practice Committee; 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes—2025. Diabetes Care 1 January 2025; 48 (Supplement_1): S239–S251. https://doi.org/10.2337/dc25-S011
[12] de Boer, I. H., Rue, T. C., Hall, Y. N., Heagerty, P. J., Weiss, N. S., & Himmelfarb, J. (2011). Temporal trends in the prevalence of diabetic kidney disease in the United States. JAMA, 305(24), 2532–2539. https://doi.org/10.1001/jama.2011.861
[13] Sinha, S. K., & Nicholas, S. B. (2023). Pathomechanisms of Diabetic Kidney Disease. Journal of clinical medicine, 12(23), 7349. https://doi.org/10.3390/jcm12237349
[14] Pradhan, A., & Tripathi, U. C. (2024). Finerenone: a breakthrough mineralocorticoid receptor antagonist for heart failure, diabetes and chronic kidney disease. The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology, 76(1), 159. https://doi.org/10.1186/s43044-024-00586-z
[15] Charakterystyka produktu leczniczego, Kerendia. INN-finerenone. https://ec.europa.eu/health/documents/community-register/2022/20220216154593/anx_154593_pl.pdf [Accessed May 5, 2025]
[16] Epstein, M., Kovesdy, C. P., Clase, C. M., Sood, M. M., & Pecoits-Filho, R. (2022). Aldosterone, Mineralocorticoid Receptor Activation, and CKD: A Review of Evolving Treatment Paradigms. American journal of kidney diseases : the official journal of the National Kidney Foundation, 80(5), 658–666. https://doi.org/10.1053/j.ajkd.2022.04.016
[17] Bakris, G. L., Agarwal, R., Anker, S. D., Pitt, B., Ruilope, L. M., Rossing, P., Kolkhof, P., Nowack, C., Schloemer, P., Joseph, A., Filippatos, G., & FIDELIO-DKD Investigators (2020). Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. The New England journal of medicine, 383(23), 2219–2229. https://doi.org/10.1056/NEJMoa2025845
[18] Pitt, B., Filippatos, G., Agarwal, R., Anker, S. D., Bakris, G. L., Rossing, P., Joseph, A., Kolkhof, P., Nowack, C., Schloemer, P., Ruilope, L. M., & FIGARO-DKD Investigators (2021). Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes. The New England journal of medicine, 385(24), 2252–2263. https://doi.org/10.1056/NEJMoa2110956
[19] Agarwal, R., Filippatos, G., Pitt, B., Anker, S. D., Rossing, P., Joseph, A., Kolkhof, P., Nowack, C., Gebel, M., Ruilope, L. M., Bakris, G. L., & FIDELIO-DKD and FIGARO-DKD investigators (2022). Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis. European heart journal, 43(6), 474–484. https://doi.org/10.1093/eurheartj/ehab777
[20] Bayer. A Study Called FINE-REAL to Learn More About the Use of the Drug Finerenone in a Routine Medical Care Setting. NCT05348733. ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT05348733 [Accessed May 7, 2025]
[21] Desai, N. R., Navaneethan, S. D., Nicholas, S. B., Pantalone, K. M., Wanner, C., Hamacher, S., Gay, A., & Wheeler, D. C. (2023). Design and rationale of FINE-REAL: A prospective study of finerenone in clinical practice. Journal of diabetes and its complications, 37(4), 108411. https://doi.org/10.1016/j.jdiacomp.2023.108411
[22] Nicholas, S. B., Correa-Rotter, R., Desai, N. R., Guo, L., Navaneethan, S. D., Pantalone, K. M., Wanner, C., Hamacher, S., Fatoba, S. T., Horvat-Broecker, A., Garreta-Rufas, A., Gay, A., Merz, M., & Wheeler, D. C. (2024). First interim results from FINE-REAL: a prospective, non-interventional, phase 4 study providing insights into the use and safety of finerenone in a routine clinical setting. Journal of nephrology, 37(8), 2223–2232. https://doi.org/10.1007/s40620-024-02070-y
[23] Pitt, B., Kober, L., Ponikowski, P., Gheorghiade, M., Filippatos, G., Krum, H., Nowack, C., Kolkhof, P., Kim, S. Y., & Zannad, F. (2013). Safety and tolerability of the novel non-steroidal mineralocorticoid receptor antagonist BAY 94-8862 in patients with chronic heart failure and mild or moderate chronic kidney disease: a randomized, double-blind trial. European heart journal, 34(31), 2453–2463. https://doi.org/10.1093/eurheartj/eht187
[24] Ferreira, J. P., Anker, S. D., Palmer, B. F., Pitt, B., Rossing, P., Ruilope, L. M., Wanner, C., Farag, Y. M. K., Horvat-Broecker, A., Lambelet, M., Brinker, M., Rohwedder, K., & Filippatos, G. (2025). Incident hyperkalaemia risk model in chronic kidney disease and diabetes: the FIDELITY programme. European heart journal, ehaf258. Advance online publication. https://doi.org/10.1093/eurheartj/ehaf258
[25] Heerspink, H. J. L., Agarwal, R., Bakris, G. L., Cherney, D. Z. I., Lam, C. S. P., Neuen, B. L., Sarafidis, P. A., Tuttle, K. R., Wanner, C., Brinker, M. D., Dizayee, S., Kolkhof, P., Schloemer, P., Vesterinen, P., Perkovic, V., & FIND-CKD investigators (2025). Design and baseline characteristics of the Finerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease (FIND-CKD) randomized trial. Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 40(2), 308–319. https://doi.org/10.1093/ndt/gfae132
[26] Bayer. A Trial to Learn How Well Finerenone Works and How Safe it is in Adult Participants With Non-diabetic Chronic Kidney Disease (FIND-CKD). NCT05047263. ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT05047263 [Accessed May 7, 2025]
[27] Heerspink, H. J. L., Birkenfeld, A. L., Cherney, D. Z. I., Colhoun, H. M., Ji, L., Mathieu, C., Groop, P. H., Pratley, R. E., Rosas, S. E., Rossing, P., Skyler, J. S., Tuttle, K. R., Lawatscheck, R., Scott, C., Edfors, R., Scheerer, M. F., Kolkhof, P., & McGill, J. B. (2023). Rationale and design of a randomised phase III registration trial investigating finerenone in participants with type 1 diabetes and chronic kidney disease: The FINE-ONE trial. Diabetes research and clinical practice, 204, 110908. https://doi.org/10.1016/j.diabres.2023.110908
[28] Bayer. A Study to Learn How Well the Study Treatment Finerenone Works and How Safe it is in People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 1 Diabetes (FINE-ONE). NCT05901831. ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT05901831 [Accessed May 7, 2025]
[29] Solomon, S. D., McMurray, J. J. V., Vaduganathan, M., Claggett, B., Jhund, P. S., Desai, A. S., Henderson, A. D., Lam, C. S. P., Pitt, B., Senni, M., Shah, S. J., Voors, A. A., Zannad, F., Abidin, I. Z., Alcocer-Gamba, M. A., Atherton, J. J., Bauersachs, J., Chang-Sheng, M., Chiang, C. E., Chioncel, O., … FINEARTS-HF Committees and Investigators (2024). Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. The New England journal of medicine, 391(16), 1475–1485. https://doi.org/10.1056/NEJMoa2407107
[30] Bayer. Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone on Morbidity (Events Indicating Disease Worsening) & Mortality (Death Rate) in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40% (FINEARTS-HF). NCT04435626. ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT04435626 [Accessed May 7, 2025]
[31] Schaefer, F., Montini, G., Kang, H. G., Walle, J. V., Zaritsky, J., Schreuder, M. F., Litwin, M., Scalise, A., Scott, H., Potts, J., Iveli, P., Breitenstein, S., & Warady, B. A. (2024). Investigating the use of finerenone in children with chronic kidney disease and proteinuria: design of the FIONA and open-label extension studies. Trials, 25(1), 203. https://doi.org/10.1186/s13063-024-08021-z
[32] Bayer. A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria (FIONA). NCT05196035. ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT05196035 [Accessed May 7, 2025]
[33] Bayer. A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria (FIONA OLE). NCT05457283. ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT05457283 [Accessed May 7, 2025]
[34] Green, J. B., Mottl, A. K., Bakris, G., Heerspink, H. J. L., Mann, J. F. E., McGill, J. B., Nangaku, M., Rossing, P., Scott, C., Gay, A., & Agarwal, R. (2023). 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). Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 38(4), 894–903. https://doi.org/10.1093/ndt/gfac198
[35] Bayer. A Study to Learn How Well the Treatment Combination of Finerenone and Empagliflozin Works and How Safe it is Compared to Each Treatment Alone in Adult Participants With Long-term Kidney Disease (Chronic Kidney Disease) and Type 2 Diabetes (CONFIDENCE). NCT05254002. ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT05254002 [Accessed May 7, 2025]
[36] Zhou, L., & Li, W. (2024). Effectiveness and safety of finerenone in Chinese CKD patients without diabetes: a retrospective, real-world study. International urology and nephrology, 56(12), 3877–3885. https://doi.org/10.1007/s11255-024-04142-1
[37] Vaduganathan, M., Filippatos, G., Claggett, B. L., Desai, A. S., Jhund, P. S., Henderson, A., Brinker, M., Kolkhof, P., Schloemer, P., Lay-Flurrie, J., Viswanathan, P., Lam, C. S. P., Senni, M., Shah, S. J., Voors, A. A., Zannad, F., Rossing, P., Ruilope, L. M., Anker, S. D., Pitt, B., … Solomon, S. D. (2024). Finerenone in heart failure and chronic kidney disease with type 2 diabetes: FINE-HEART pooled analysis of cardiovascular, kidney and mortality outcomes. Nature medicine, 30(12), 3758–3764. https://doi.org/10.1038/s41591-024-03264-4
[38] Mima, A., Lee, R., Murakami, A., Gotoda, H., Akai, R., Kidooka, S., Nakamoto, T., Kido, S., & Lee, S. (2023). Effect of finerenone on diabetic kidney disease outcomes with estimated glomerular filtration rate below 25 mL/min/1.73 m2. Metabolism open, 19, 100251. https://doi.org/10.1016/j.metop.2023.100251
[39] Rossing, P., Garweg, J. G., Anker, S. D., Osonoi, T., Pitt, B., Rosas, S. E., Ruilope, L. M., Zhu, D., Brinker, M., Finis, D., Leal, S., Schmelter, T., & Bakris, G. (2023). Effect of finerenone on the occurrence of vision-threatening complications in patients with non-proliferative diabetic retinopathy: Pooled analysis of two studies using routine ophthalmological examinations from clinical trial participants (ReFineDR/DeFineDR). Diabetes, obesity & metabolism, 25(3), 894–898. https://doi.org/10.1111/dom.14915
[40] Bayer. A Study That Uses Data From Routine Eye Examinations of Patients Participating in Studies FIDELIO-DKD and FIGARO-DKD to Explore Whether Finerenone Can Delay the Progression of a Diabetes Complication That Affects the Eyes (Diabetic Retinopathy ,DR) (ReFineDR). NCT04477707. ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT04477707 [Accessed May 7, 2025]
[41] Bayer. A Study That Uses Data From Routine Eye Examinations of Patients Participating in Studies FIDELIO-DKD and FIGARO-DKD to Explore Whether Finerenone Can Delay the Progression of a Diabetes Complication That Affects the Eyes (Diabetic Retinopathy, DR) (DeFineDR). NCT04795726. ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT04795726 [Accessed May 7, 2025]
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Copyright (c) 2025 Cezary Kubuj, Grzegorz Adaśko, Michał Świda, Jakub Bazarewicz, Urszula Mazur, Marcin Siwik, Daniel Dmowski, Anna Michalska, Paulina Ogonowska, Julia Waszak

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