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

Status of a Carbon-Ion Therapy Facility and Development for Advanced Treatment

Over 3000 cancer patients have already been treated with 140- to 400-MeV/n carbon beams produced by the heavy ion medical accelerator in Chiba (HIMAC) at the National Institute of Radiological Sciences (NIRS) since 1994. These clinical results have clearly verified the advantages of carbon ions. Based on our experience at HIMAC, a hospital-specific facility optimized for carbon-ion therapy has been designed. The prototype developments of an electron cyclotron resonance (ECR) ion source, a radio frequency quadruple (RFQ) linac, an inter digital H (IH) linac, an acceleration system of synchrotron, a beam-delivery system and other key-technology parts have been successfully finished. Thus, in co-operation with NIRS, Gunma University has been constructing a carbon-therapy facility since April, 2006. If the present clinical results are to be improved, it is necessary to create a more accurate dose distribution on tumors without an undesired dose being deposited in normal tissue. Beam-scanning methods with respiration-gated irradiation are especially important to treat a cancer tumor located in the trunk of a patient