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

Luis M. Ruilope, Rajiv Agarwal, Juliana C. Chan, Mark E. Cooper, Ron T. Gansevoort, Hermann Haller, Giuseppe Remuzzi, Peter Rossing, Roland E. Schmieder, Christina Nowack, Anna C. Ferreira, Alexander Pieper, Nina Kimmeskamp-Kirschbaum, George L. Bakris

Research output: Contribution to journalArticle

Abstract

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 m2; 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.

Original languageEnglish
Pages (from-to)572-581
Number of pages10
JournalAmerican Journal of Nephrology
Volume40
Issue number6
DOIs
Publication statusPublished - Feb 24 2014

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Diabetic Nephropathies
Type 2 Diabetes Mellitus
Albuminuria
Safety
Placebos
Mineralocorticoid Receptor Antagonists
Renin-Angiotensin System
Potassium
Blood Pressure
Diabetic Neuropathies
Diabetic Retinopathy
BAY 94-8862
Serum
Glomerular Filtration Rate
Chronic Renal Insufficiency
Albumins
Creatinine
Cardiovascular Diseases
Heart Failure
Biomarkers

Keywords

  • Antagonist
  • Diabetic nephropathy
  • Heart failure
  • Mineralocorticoid receptor
  • Type 2 diabetes mellitus

ASJC Scopus subject areas

  • Nephrology
  • Medicine(all)

Cite this

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. / Ruilope, Luis M.; Agarwal, Rajiv; Chan, Juliana C.; Cooper, Mark E.; Gansevoort, Ron T.; Haller, Hermann; Remuzzi, Giuseppe; Rossing, Peter; Schmieder, Roland E.; Nowack, Christina; Ferreira, Anna C.; Pieper, Alexander; Kimmeskamp-Kirschbaum, Nina; Bakris, George L.

In: American Journal of Nephrology, Vol. 40, No. 6, 24.02.2014, p. 572-581.

Research output: Contribution to journalArticle

Ruilope, LM, Agarwal, R, Chan, JC, Cooper, ME, Gansevoort, RT, Haller, H, Remuzzi, G, Rossing, P, Schmieder, RE, Nowack, C, Ferreira, AC, Pieper, A, Kimmeskamp-Kirschbaum, N & Bakris, GL 2014, '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, vol. 40, no. 6, pp. 572-581. https://doi.org/10.1159/000371497
Ruilope, Luis M. ; Agarwal, Rajiv ; Chan, Juliana C. ; Cooper, Mark E. ; Gansevoort, Ron T. ; Haller, Hermann ; Remuzzi, Giuseppe ; Rossing, Peter ; Schmieder, Roland E. ; Nowack, Christina ; Ferreira, Anna C. ; Pieper, Alexander ; Kimmeskamp-Kirschbaum, Nina ; Bakris, George L. / 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. In: American Journal of Nephrology. 2014 ; Vol. 40, No. 6. pp. 572-581.
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abstract = "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 m2; 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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T2 - 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

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AU - Agarwal, Rajiv

AU - Chan, Juliana C.

AU - Cooper, Mark E.

AU - Gansevoort, Ron T.

AU - Haller, Hermann

AU - Remuzzi, Giuseppe

AU - Rossing, Peter

AU - Schmieder, Roland E.

AU - Nowack, Christina

AU - Ferreira, Anna C.

AU - Pieper, Alexander

AU - Kimmeskamp-Kirschbaum, Nina

AU - Bakris, George L.

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N2 - 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 m2; 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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KW - Antagonist

KW - Diabetic nephropathy

KW - Heart failure

KW - Mineralocorticoid receptor

KW - Type 2 diabetes mellitus

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