Article open access publication

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

American Journal of Nephrology, Karger Publishers, ISSN 0250-8095

Volume 40, 6, 2014

DOI:10.1159/000371497, Dimensions: pub.1012166483, PMID: 25591469,

Authors

Ruilope, Luis M (1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Agarwal, Rajiv (1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Chan, Juliana C. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Cooper, Mark E. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Gansevoort, Ron T (1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Haller, Hermann (1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Remuzzi, Giuseppe (1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Rossing, Peter (1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Schmieder, Roland E (1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Nowack, Christina (1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Ferreira, Anna C (1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Pieper, Alexander (1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Kimmeskamp-Kirschbaum, Nina (1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Bakris, George L. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

Affiliations

Organisations

  1. (1) Baker IDI Heart and Diabetes Institute, grid.1051.5
  2. (2) Chinese University of Hong Kong, grid.10784.3a
  3. (3) Hannover Medical School, grid.10423.34
  4. (4) Hospital Universitario 12 De Octubre, grid.144756.5
  5. (5) Institute of Investigation and Hypertension Unit, Hospital 12 de Octubre, Madrid, Spain;, Richard L. Roudebush VA Medical Center, Indianapolis, Ind., USA;, Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, SAR, China;, Baker IDI Heart and Diabetes Institute, Melbourne, Australia;, Department of Nephrology, University Medical Center Groningen, Groningen, The Netherlands;, Departments of Nephrology and Hypertension, Hannover Medical School, Hannover, Department of Nephrology and Hypertension, University Hospital Erlangen, Erlangen, Global Clinical Development, Bayer HealthCare AG, Leverkusen, M.A.R.C.O. GmbH & Co. KG, Düsseldorf, and, Global Research and Development Statistics, Bayer HealthCare AG, Leverkusen, Germany;, IRCCS - Istituto di Ricerche Farmacologiche Mario Negri, Clinical Research Center for Rare Diseases ‘Aldo e Cele Daccò', Ranica (Bergamo), and, Unit of Nephrology and Dialysis, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy;, Steno Diabetes Center, Gentofte, Denmark;, Global Clinical Development, Bayer S.A., Bayer HealthCare, São Paulo, Brazil;, The University of Chicago Medicine, Chicago, Ill., USA
  6. (6) Ospedale Papa Giovanni XXIII, grid.460094.f
  7. (7) Richard L. Roudebush VA Medical Center, grid.280828.8
  8. (8) Steno Diabetes Center, grid.419658.7, Capital Region
  9. (9) University Medical Center Groningen, grid.4494.d
  10. (10) University of Chicago, grid.170205.1

Description

BACKGROUND/AIMS: 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. CONCLUSION: 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.

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