Design and baseline characteristics of the finerenone in reducing kidney failure and disease progression in diabetic kidney disease trial

George L. Bakris, Rajiv Agarwal, Stefan D. Anker, Bertram Pitt, Luis M. Ruilope, Christina Nowack, Peter Kolkhof, Anna C. Ferreira, Patrick Schloemer, Gerasimos Filippatos

Research output: Contribution to journalArticle

1 Citation (Scopus)

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.

Original languageEnglish (US)
JournalAmerican Journal of Nephrology
DOIs
StateAccepted/In press - Jan 1 2019

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Kidney Diseases
Diabetic Nephropathies
Renal Insufficiency
Disease Progression
Chronic Renal Insufficiency
Type 2 Diabetes Mellitus
Kidney
Albuminuria
Glomerular Filtration Rate
Placebos
Mineralocorticoid Receptor Antagonists
Hyperkalemia
Risk Reduction Behavior
Albumins
Creatinine
BAY 94-8862
Morbidity
Safety
Mortality

Keywords

  • Aldosterone
  • Clinical
  • Diabetes
  • Kidney
  • Mineralocorticoid
  • Outcomes

ASJC Scopus subject areas

  • Nephrology

Cite this

Design and baseline characteristics of the finerenone in reducing kidney failure and disease progression in diabetic kidney disease trial. / Bakris, George L.; Agarwal, Rajiv; Anker, Stefan D.; Pitt, Bertram; Ruilope, Luis M.; Nowack, Christina; Kolkhof, Peter; Ferreira, Anna C.; Schloemer, Patrick; Filippatos, Gerasimos.

In: American Journal of Nephrology, 01.01.2019.

Research output: Contribution to journalArticle

Bakris, George L. ; Agarwal, Rajiv ; Anker, Stefan D. ; Pitt, Bertram ; Ruilope, Luis M. ; Nowack, Christina ; Kolkhof, Peter ; Ferreira, Anna C. ; Schloemer, Patrick ; Filippatos, Gerasimos. / Design and baseline characteristics of the finerenone in reducing kidney failure and disease progression in diabetic kidney disease trial. In: American Journal of Nephrology. 2019.
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T1 - Design and baseline characteristics of the finerenone in reducing kidney failure and disease progression in diabetic kidney disease trial

AU - Bakris, George L.

AU - Agarwal, Rajiv

AU - Anker, Stefan D.

AU - Pitt, Bertram

AU - Ruilope, Luis M.

AU - Nowack, Christina

AU - Kolkhof, Peter

AU - Ferreira, Anna C.

AU - Schloemer, Patrick

AU - Filippatos, Gerasimos

PY - 2019/1/1

Y1 - 2019/1/1

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AB - 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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KW - Mineralocorticoid

KW - Outcomes

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