New Clinical Guidelines Recommend Finerenone for CKD Associated With T2D

An update to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines recommends finerenone (Kerendia), a first-in-class, nonsteroidal mineralocorticoid receptor antagonist (ns-MRA), as part of a comprehensive treatment regimen for patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). A consensus report jointly published by KDIGO and the American Diabetes Association (ADA) echoes the recommendation.

The FDA approved finerenone in July 2021 based on the results of the pivotal FIDELIO-DKD trial, then approved an updated label in September 2022 based on findings from the phase III FIGARO-DKD cardiovascular outcomes study. Finerenone is indicated to reduce the risk of estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction (MI), and hospitalization for heart failure in CKD associated with type 1 diabetes.

The new clinical guidelines recommend finerenone for patients with CKD associated with T2D and an eGFR of ≥25 mL/min/1.73 m², as well as normal serum potassium concentration and albuminuria despite treatment with a renin-angiotensin system (RAS) inhibitor at the maximum tolerated dose.

“Kerendia’s inclusion in the KDIGO guideline update and ADA and KDIGO consensus report reinforces its foundational and critical role in a multipillar treatment strategy for patients with CKD associated with T2D who seek cardiorenal risk reduction and continue to struggle with persistent albuminuria despite current standard of care treatment,” said George Bakris, MD, coauthor of the report and director of the Comprehensive Hypertension Center at the University of Chicago, in a statement. “It is compelling that we now have a general agreement between diabetologists and nephrologists on the use of Kerendia as part of a treatment plan for patients with CKD associated with T2D.”

Both the ADA and the American Association of Clinical Endocrinology have included finerenone in clinical recommendations in the past year. The KDIGO recommendations and joint report based finerenone’s inclusion on FIDELIO-DKD and FIGARO-DKD findings in addition to an exploratory pooled analysis of the trials that includes more than 13,000 patients with CKD associated with T2D. The FIDELITY analysis is one of the largest cardiorenal outcomes programs to research the incidence of fatal and nonfatal cardiovascular events and progression of kidney disease in this patient group.

In the FIDELIO-DKD trial, finerenone reduced the incidence of a sustained decline in eGFR of 40% or greater, kidney failure, or renal death—all part of a composite end point. It also reduced the risk of cardiovascular death, nonfatal MI, nonfatal stroke, or hospitalization for heart failure as a secondary composite end point. In FIGARO-DKD, finerenone reduced the incidence of cardiovascular death, nonfatal MI, nonfatal stroke, or hospitalization for heart failure as a main composite end point. Safety findings were satisfactory across both studies.

Overall, the updated guidelines diversify recommendations for treating patients with CKD associated with T1D, with agreement between key provider groups for these patients.

“There has been a longstanding need in the CKD space for treatment options and multimodal approaches to patient care,” said Daniel J. Wilson, MD, FACP, FCCP, senior medical director of cardiovascular and renal, US Medical Affairs at Bayer. “… KERENDIA’s comprehensive clinical trial program, inclusive of patients comprising a range of disease severity and demonstrated evidence in providing cardiorenal risk reduction, has helped establish its place as an important piece of a comprehensive treatment paradigm for CKD associated with T2D.”

Reference

Bayer’s KERENDIA (finerenone) recommended as part of comprehensive treatment strategy for chronic kidney disease associated with type 2 diabetes in newly published clinical recommendations. News release. Bayer. October 27, 2022. Accessed November 18, 2022. https://bayer2019tf.q4web.com/news/news-details/2022/Bayers-KERENDIA-finerenone-Recommended-as-Part-of-Comprehensive-Treatment-Strategy-for-Chronic-Kidney-Disease-Associated-With-Type-2-Diabetes-in-Newly-Published-Clinical-Recommendations/default.aspx