Rationale and design of an investigator-initiated, multicenter, prospective, placebo-controlled, double-blind, randomized trial to evaluate the effects of finerenone on vascular stiffness and cardiorenal biomarkers in type 2 diabetes and chronic kidney disease (FIVE-STAR)

• Published in: Cardiovascular diabetology Vol. 22; no. 1; pp. 194 - 11
• Main Authors: Tanaka, Atsushi, Shibata, Hirotaka, Imai, Takumi, Yoshida, Hisako, Miyazono, Motoaki, Takahashi, Naohiko, Fukuda, Daiju, Okada, Yosuke, Teragawa, Hiroki, Suwa, Satoru, Kida, Keisuke, Moroi, Masao, Taguchi, Isao, Toyoda, Shigeru, Shimabukuro, Michio, Tanabe, Kengo, Tanaka, Kenichi, Nangaku, Masaomi, Node, Koichi
• Format: Journal Article
• Language: English
• Published: England BioMed Central 31.07.2023; BMC
• Subjects: Ankle; Biomarker; Biomarkers; Blood pressure; Chronic kidney disease; Clinical trials; Consent; Creatinine; Diabetes; Diabetes mellitus (non-insulin dependent); Diabetes Mellitus, Type 2 - complications; Diabetes Mellitus, Type 2 - diagnosis; Diabetes Mellitus, Type 2 - drug therapy; Diabetic Nephropathies - diagnosis; Diabetic Nephropathies - drug therapy; Double-Blind Method; Double-blind studies; Drug dosages; Drug therapy; Ejection fraction; Epidermal growth factor receptors; Finerenone; Humans; Inflammation; Kidney diseases; Mineralocorticoid receptors; Mortality; Patients; Placebos; Potassium; Prospective Studies; Proteomics; Renal Insufficiency, Chronic - complications; Renal Insufficiency, Chronic - diagnosis; Renal Insufficiency, Chronic - drug therapy; Study Protocol; Type 2 diabetes; Vascular Stiffness; Japan; Type 2 diabetes; Biomarker; Chronic kidney disease; Finerenone; Vascular stiffness

The overactivation of mineralocorticoid receptor (MR) plays a key pathological role in the progression of cardiovascular and renal diseases by promoting pro-inflammatory and pro-fibrotic signaling. Recently, it has been found that finerenone, a novel nonsteroidal selective MR antagonist, can robustl...