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

The Gaia-ESO Survey: Calibrating the lithium-age relation with open clusters and associations. I. Cluster age range and initial membership selections

Previous studies of open clusters have shown that lithium depletion is not only strongly age dependent but also shows a complex pattern with other parameters that is not yet understood. For pre- and main-sequence late-type stars, these parameters include metallicity, mixing mechanisms, convection structure, rotation, and magnetic activity. We perform a thorough membership analysis for a large number of stars observed within the Gaia-ESO survey (GES) in the field of 20 open clusters, ranging in age from young clusters and associations, to intermediate-age and old open clusters. Based on the parameters derived from the GES spectroscopic observations, we obtained lists of candidate members for each of the clusters in the sample by deriving RV distributions and studying the position of the kinematic selections in the EW(Li) versus Teff plane to obtain lithium members. We used gravity indicators to discard field contaminants and studied [Fe/H] metallicity to further confirm the membership of the candidates. We also made use of studies using recent data from the Gaia DR1 and DR2 releases to assess our member selections. We identified likely member candidates for the sample of 20 clusters observed in GES (iDR4) with UVES and GIRAFFE, and conducted a comparative study that allowed us to characterize the properties of these members, as well as identify field contaminant stars, both lithium-rich giants and non-giant outliers. This work is the first step towards the calibration of the lithium-age relation and its dependence on other GES parameters. During this project we aim to use this relation to infer the ages of GES field stars, and identify their potential membership to young associations and stellar kinematic groups of different ages