George L Bakris1, Rajiv Agarwal2, Stefan D Anker3, Bertram Pitt4, Luis M Ruilope5,6,7, Christina Nowack8, Peter Kolkhof9, Anna C Ferreira10, Patrick Schloemer11, Gerasimos Filippatos12,13. 1. Department of Medicine, University of Chicago Medicine, Chicago, Illinois, USA, gbakris@gmail.com. 2. Richard L. Roudebush VA Medical Center and Indiana University, Indianapolis, Indiana, USA. 3. Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany. 4. Department of Medicine, University of Michigan School of Medicine, Ann Arbor, Michigan, USA. 5. Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research i+12, Hospital Universitario 12 de Octubre, Madrid, Germany. 6. CIBER-CV, Hospital Universitario 12 de Octubre, Madrid, Spain. 7. Faculty of Sport Sciences, European University of Madrid, Madrid, Spain. 8. Research and Development, Clinical Development Operations, Bayer AG, Wuppertal, Germany. 9. Research and Development, Preclinical Research Cardiovascular, Bayer AG, Wuppertal, Germany. 10. Research and Development, Clinical Operations, Bayer SA, São Paulo, Brazil. 11. Research and Development, Statistics and Data Insights, Bayer AG, Berlin, Germany. 12. Department of Cardiology, Attikon University Hospital, Athens, Greece. 13. University of Cyprus, Medical School, Nicosia, Cyprus.
Abstract
BACKGROUND: Among diabetics, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality, and progression of their underlying disease. Finerenone is a novel, non-steroidal, selective mineralocorticoid-receptor antagonist which has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD), while revealing only a low risk of hyperkalemia. However, the effect of finerenone on renal and CV outcomes has not been investigated in long-term trials yet. METHODS: The Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease -(FIDELIO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important renal and CV outcomes in T2D patients with CKD. FIDELIO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 5.5 years. FIDELIO-DKD randomized 5,734 patients with an estimated glomerular filtration rate (eGFR) ≥25-<75 mL/min/1.73 m2 and albuminuria (urinary albumin-to-creatinine ratio ≥30-≤5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of primary outcome (overall two-sided significance level α = 0.05), the composite of time to first occurrence of kidney failure, a sustained decrease of eGFR ≥40% from baseline over at least 4 weeks, or renal death. CONCLUSION: FIDELIO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of renal and CV events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen.
RCT Entities:
BACKGROUND: Among diabetics, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality, and progression of their underlying disease. Finerenone is a novel, non-steroidal, selective mineralocorticoid-receptor antagonist which has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD), while revealing only a low risk of hyperkalemia. However, the effect of finerenone on renal and CV outcomes has not been investigated in long-term trials yet. METHODS: The Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease -(FIDELIO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important renal and CV outcomes in T2D patients with CKD. FIDELIO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 5.5 years. FIDELIO-DKD randomized 5,734 patients with an estimated glomerular filtration rate (eGFR) ≥25-<75 mL/min/1.73 m2 and albuminuria (urinary albumin-to-creatinine ratio ≥30-≤5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of primary outcome (overall two-sided significance level α = 0.05), the composite of time to first occurrence of kidney failure, a sustained decrease of eGFR ≥40% from baseline over at least 4 weeks, or renal death. CONCLUSION: FIDELIO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of renal and CV events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen.
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