Why the study?
Despite standard of care, patients with CKD and T2D progress to dialysis, heart failure hospitalization, and premature death, driven in part by mineralocorticoid receptor overactivation.
Does finerenone improve kidney failure and cardiovascular outcomes in patients with chronic kidney disease and type 2 diabetes?
Does finerenone improve kidney failure and cardiovascular outcomes in patients with chronic kidney disease and type 2 diabetes?
This review outlines the rationale and design of the FIDELIO-DKD and FIGARO-DKD trials investigating finerenone for cardiorenal protection in patients with CKD and T2D.
Finerenone's cardiorenal role in CKD with T2D remains unproven; these trial designs leave open whether benefits will be confirmed.
Despite the standard of care, patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) progress to dialysis, are hospitalized for heart failure and die prematurely. Overactivation of the mineralocorticoid receptor (MR) causes inflammation and fibrosis that damages the kidney and heart. Finerenone, a nonsteroidal, selective MR antagonist, confers kidney and heart protection in both animal models and Phase II clinical studies; the effects on serum potassium and kidney function are minimal. Comprising the largest CKD outcomes program to date, FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) and FIGARO-DKD (FInerenone in reducinG cArdiovascular moRtality and mOrbidity in Diabetic Kidney Disease) are Phase III trials investigating the efficacy and safety of finerenone on kidney failure and cardiovascular outcomes from early to advanced CKD in T2D. By including echocardiograms and biomarkers, they extend our understanding of pathophysiology; by including quality of life measurements, they provide patient-centered outcomes; and by including understudied yet high-risk cardiorenal subpopulations, they have the potential to widen the scope of therapy in T2D with CKD. Trial registration number: FIDELIO-DKD (NCT02540993) and FIGARO-DKD (NCT02545049).
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Agarwal et al. (2020) studied this question.
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