Design and baseline characteristics of the finerenone in reducing cardiovascular mortality and morbidity in diabetic kidney disease trial

Background: Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that 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 CV and renal outcomes has not yet been investigated in long-term trials. Patients and Methods: The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate >= 25 mL/min/1.73 m(2) and albuminuria (urinary albumin-to-creatinine ratio >= 30 to <= 5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level alpha = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Conclusions: FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen. Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049

International Sports Justice

This book deals with the dispute settlement mechanisms of a multitude of international sports organizations, considering the development of international sports justice and its relationship with ordinary justice. The Authors are all eminent scholars, independent practitioners, in-house lawyers and arbitrators, who provide in-depth review and insight into the complexities of the topic. The book is divided into three parts. The first covers the functioning, procedures and case law of the Court of Arbitration for Sport and of Sport Resolutions. The second part focuses on the internal justice mechanisms of major sports associations and organisations in several sports. Particular attention is given to the structure and rules of sports internal judicial bodies, the relevant proceedings, the eligibility, employment, economic and technical disputes, by also taking into due account the relevant case law. The third part deals with international sports leagues and their peculiarities. Finally, the conclusions offer a brief comparative analysis of the examined sports justice systems in order to identify the critical issues, but also the best practices, hopefully paving the way for achieving the best possible international sports justice