Clinical Trial Details

NCT ID: NCT02540993
Date Last Changed: September 13, 2017

Overview

Research Study Summary

A clinical trial seeking patients for a research study for the treatment of Diabetic Kidney Disease

Research Study Title

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate the Safety and Efficacy of Finerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease

Purpose

The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.

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Recruitment Details

Phase
3
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Bayer
Duration
48 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Inclusion Criteria:

  • Men or women ≥18 years of age

  • Subjects with Type 2 diabetes mellitus as defined by the American Diabetes Association

  • Diagnosis of diabetic kidney disease (DKD) with persistent high albuminuria or persistent very high albuminuria at the Run-in and Screening visits:

  • Pretreated with either angiotensin-converting enzyme inhibitor(ACEI) or angiotensin receptor blocker (ARB) at maximal tolerated labeled dose without adjustments

  • Serum potassium < =4.8 mmol/L.

Exclusion Criteria:

  • Confirmed significant non-diabetic renal disease, including clinically relevant renal artery stenosis

  • Uncontrolled arterial hypertension (ie, mean sitting systolic blood pressure (SBP) ≥170 mmHg, sitting diastolic blood pressure (DBP) ≥110 mmHg at run in visit, or mean sitting SBP ≥160 mmHg, sitting DBP ≥100 mmHg at screening)

  • Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms New York Heart Association (NYHA class II - IV) at run in visit (class 1A recommendation for mineralcorticoid receptor antagonist (MRAs)

  • Dialysis for acute renal failure within 12 weeks of run in visit

  • Renal allograft in place or scheduled kidney transplant within next 12 months

  • Glycated hemoglobin HbA1c > 12%.

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Poland Katowice 40-040 Research Site
Poland Krakow 30-015 Research Site
Poland Krakow 31-209 Research Site
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Poland Kraków 30-002 Research Site
Poland Lodz 90-153 Research Site
Poland Lodz 90-549 Research Site
Poland Lodz 91-089 Research Site
Poland Lublin 20-538 Research Site
Poland Poznan 60-192 Research Site
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Poland Warszawa 01-868 Research Site
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Poland Wroclaw 51-162 Research Site
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Portugal Lisboa Loures 2674-514 Research Site
Portugal Porto Senhora da Hora - Matosinhos 4464-513 Research Site
Portugal Viana do Castelo Vana do Castelo 4901-858 Research Site
Portugal Almada 2801-951 Research Site
Portugal Amadora 2720-276 Research Site
Portugal Braga 4710-243 Research Site
Portugal Covilhã Research Site
Portugal Leiria 2410-197 Research Site
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Romania Maramures Baia Mare 430222 Research Site
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Russian Federation Arkhangelsk 163001 Research Site
Russian Federation Irkutsk 664079 Research Site
Russian Federation Izhevsk 426063 Research Site
Russian Federation Kazan 420012 Research Site
Russian Federation Kemerovo 650002 Research Site
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Russian Federation Nizhny Novgorod 603018 Research Site
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Russian Federation Omsk 644024 Research Site
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Russian Federation Orenburg 460000 Research Site
Russian Federation Perm 614097 Research Site
Russian Federation Ryazan 390026 Research Site
Russian Federation Saratov 410030 Research Site
Russian Federation St. Petersburg 190068 Research Site
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Slovakia Nitra 949 11 Research Site
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South Africa Eastern Cape Port Elizabeth 6045 Research Site
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South Africa Mpumalanga Middelburg 1050 Research Site
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South Africa Western Cape Cape Town 7569 Research Site
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Ukraine Cherkasy 18009 Research Site
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