title: A randomized controlled study of finerenone versus placebo in Japanese patients with type 2 diabetes mellitus and diabetic nephropathy.
abstract: OBJECTIVE
  Finerenone (BAY 94-8862) is a novel non-steroidal mineralocorticoid receptor antagonist. The aim of this study was to compare the efficacy and safety of seven once-daily oral doses of finerenone (1.25-20mg) and placebo in 96 patients with type 2 diabetes mellitus (T2DM) and diabetic nephropathy (DN) receiving a RAS blocker.
  
  
  METHODS
  ARTS-DN Japan was a multicenter, randomized, double-blind, placebo-controlled, phase 2b study.
  
  
  RESULTS
  Analysis of the urinary albumin-to-creatinine ratio (UACR) at day 90 relative to baseline indicated a nominally significant effect of finerenone. The UACR at day 90 relative to baseline for each finerenone treatment group was numerically reduced compared with placebo. No serious adverse events (AEs) or deaths were reported and no patients experienced treatment-emergent AEs resulting in discontinuation of study drug. Small mean increases in serum potassium level were observed in the finerenone treatment groups (0.025-0.167mmol/L) compared with the placebo group (-0.075mmol/L); no patients developed hyperkalemia.
  
  
  CONCLUSIONS
  When given in addition to a RAS inhibitor, finerenone reduced albuminuria without adverse effects on serum potassium levels or renal function in Japanese patients with T2DM and DN.
authors.affiliation: Kawagoe Clinic, Saitama Medical University, Saitama, Japan. Electronic address: skataya@saitama-med.ac.jp.
authors.forename: Shigehiro
authors.initials: S
authors.lastname: Katayama
authors.affiliation: Jiyugaoka Yamada Clinic, Hokkaido, Japan.
authors.forename: Daishiro
authors.initials: D
authors.lastname: Yamada
authors.affiliation: Nakayama Clinic, Aichi, Japan.
authors.forename: Mikihiro
authors.initials: M
authors.lastname: Nakayama
authors.affiliation: Bayer Yakuhin, Ltd, Osaka, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Yamada
authors.affiliation: Bayer Yakuhin, Ltd, Osaka, Japan.
authors.forename: Masafumi
authors.initials: M
authors.lastname: Myoishi
authors.affiliation: Bayer Yakuhin, Ltd, Osaka, Japan.
authors.forename: Masaharu
authors.initials: M
authors.lastname: Kato
authors.affiliation: Global Clinical Development, Bayer Pharma AG, Wuppertal, Germany.
authors.forename: Christina
authors.initials: C
authors.lastname: Nowack
authors.affiliation: Heart Diseases Research, Global Drug Discovery, Bayer Pharma AG, Wuppertal, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Kolkhof
authors.affiliation: AMC Nishi Umeda Clinic, Osaka, Japan.
authors.forename: Yoshimitsu
authors.initials: Y
authors.lastname: Yamasaki
mesh_terms: D000368:Aged; D000419:Albuminuria / Q000209:etiology / Q000517:prevention & control*; D015415:Biomarkers / Q000097:blood / Q000652:urine; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D003928:Diabetic Nephropathies / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology / Q000652:urine; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006801:Humans; D007564:Japan; D007668:Kidney / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D000451:Mineralocorticoid Receptor Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D009287:Naphthyridines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D051437:Renal Insufficiency / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism / Q000503:physiopathology; D012084:Renin-Angiotensin System / Q000187:drug effects; D015203:Reproducibility of Results
chemical_list: D015415:Biomarkers; D000451:Mineralocorticoid Receptor Antagonists; D009287:Naphthyridines; C576501:finerenone
keywords: Albuminuria; Diabetic nephropathy; Finerenone; MRA; Type 2 diabetes