title: Rationale, design, and baseline characteristics of ARTS-DN: a randomized study to assess the safety and efficacy of finerenone in patients with type 2 diabetes mellitus and a clinical diagnosis of diabetic nephropathy.
abstract: OBJECTIVE
  Finerenone decreases albuminuria in patients having heart failure with reduced ejection fraction and mild-to-moderate (stage 2-3) chronic kidney disease. The MinerAlocorticoid Receptor Antagonist Tolerability Study-Diabetic Nephropathy (ARTS-DN; NCT01874431) is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 2b study. ARTS-DN investigated whether the mineralocorticoid receptor antagonist finerenone reduces albuminuria without causing major alterations in serum potassium levels in patients with type 2 diabetes mellitus and a clinical diagnosis of DN who were receiving a renin-angiotensin-system (RAS) inhibitor.
  
  
  METHODS
  Patients were randomized to oral finerenone 1.25-20 mg or placebo once daily. The primary objectives were to assess the ratio of the urinary albumin-to-creatinine ratio at day 90 to that at baseline in patients receiving finerenone, and to compare it with that in the placebo group. Additional exploratory analyses included evaluating changes from baseline in serum potassium levels, efficacy and safety biomarkers, and health-related quality of life.
  
  
  RESULTS
  Of 1,501 patients screened, 821 (the sample population) received at least one dose of finerenone/placebo. Baseline characteristics included: male, 77.8%; white, 84.2%; very high albuminuria (formerly macroalbuminuria), 38.4%; high albuminuria (formerly microalbuminuria), 60.3%; median (range) estimated glomerular filtration rate, 66.3 (24.5-130.7) ml/min/1.73 m(2); and systolic blood pressure (mean ± standard deviation), 138.1 ± 14.4 mm Hg. There was a history of cardiovascular disease in 39.6%, diabetic neuropathy in 20.0%, and diabetic retinopathy in 19.9% of patients.
  
  
  CONCLUSIONS
  ARTS-DN is the first phase 2b trial of finerenone in combination with a RAS inhibitor in patients with type 2 diabetes mellitus and a clinical diagnosis of DN.
authors.affiliation: Institute of Investigation and Hypertension Unit, Hospital 12 de Octubre, Madrid, Spain.
authors.forename: Luis M
authors.initials: LM
authors.lastname: Ruilope
authors.forename: Rajiv
authors.initials: R
authors.lastname: Agarwal
authors.forename: Juliana C
authors.initials: JC
authors.lastname: Chan
authors.forename: Mark E
authors.initials: ME
authors.lastname: Cooper
authors.forename: Ron T
authors.initials: RT
authors.lastname: Gansevoort
authors.forename: Hermann
authors.initials: H
authors.lastname: Haller
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Remuzzi
authors.forename: Peter
authors.initials: P
authors.lastname: Rossing
authors.forename: Roland E
authors.initials: RE
authors.lastname: Schmieder
authors.forename: Christina
authors.initials: C
authors.lastname: Nowack
authors.forename: Anna C
authors.initials: AC
authors.lastname: Ferreira
authors.forename: Alexander
authors.initials: A
authors.lastname: Pieper
authors.forename: Nina
authors.initials: N
authors.lastname: Kimmeskamp-Kirschbaum
authors.forename: George L
authors.initials: GL
authors.lastname: Bakris
mesh_terms: D000368:Aged; D000419:Albuminuria / Q000188:drug therapy* / Q000652:urine; D057911:Angiotensin Receptor Antagonists / Q000627:therapeutic use; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use; D000959:Antihypertensive Agents / Q000627:therapeutic use; D001794:Blood Pressure; D003404:Creatinine / Q000652:urine; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D003928:Diabetic Nephropathies / Q000188:drug therapy* / Q000209:etiology / Q000652:urine; D004311:Double-Blind Method; D065627:Familial Primary Pulmonary Hypertension / Q000150:complications / Q000188:drug therapy; D005260:Female; D005919:Glomerular Filtration Rate; D006801:Humans; D008297:Male; D008875:Middle Aged; D000451:Mineralocorticoid Receptor Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D009287:Naphthyridines / Q000008:administration & dosage* / Q000009:adverse effects; D011188:Potassium / Q000097:blood
chemical_list: D057911:Angiotensin Receptor Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors; D000959:Antihypertensive Agents; D000451:Mineralocorticoid Receptor Antagonists; D009287:Naphthyridines; C576501:finerenone; D003404:Creatinine; D011188:Potassium