Trial Condition(s):

Diabetic Nephropathies

Safety and efficacy of different oral doses of BAY94-8862 in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic nephropathy (ARTS-DN)

Bayer Identifier:

16243

ClinicalTrials.gov Identifier:

NCT01874431

EudraCT Number:

2012-004179-38

Study Completed

Trial Purpose

To assess a new drug, BAY94-8862 given orally at different doses, to evaluate whether it was safe and can help the well being of patients with type 2 diabetes and diabetic nephropathy. These treatment doses were compared to placebo.

Inclusion Criteria
- Men and women aged 18 years and older.The lower age limit may be higher if legally required in the participating country
 - Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active.
 - Subjects with type 2 diabetes mellitus fulfilling at least 1 of the following criteria 
 -- are on oral antidiabetics and / or insulin, 
 -- have a documented fasting glucose >/= 7.0 mmol/L in the medical history, 
 -- have a 2 hour plasma glucose >/=11.1 mmol/L during an oral glucose tolerance test in the medical history, or 
 -- have a glycated hemoglobin (HbA1c) >/=6.5%  [National Glycohemoglobin Standardization Program (NGSP) / Diabetes Control and Complications Trial (DCCT)] in the medical history or at the run-in visit
 - Subjects with a clinical diagnosis of diabetic nephropathy (DN) based on at least 1 of the following criteria:
 -- Persistent very high albuminuria defined as urinary albumin-to-creatine ratio (UACR) of >/=300 mg/g ( >/= 34 mg/mmol) in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) >/=30 mL/min/1.73 m²  but < 90 mL/min/1.73m² (Chronic Kidney Disease Epidemiology Collaboration, CKD EPI) (mL = milliliter; min = minute; m2 = square meter; g = gram; mmol = millimole) or
 -- Persistent high albuminuria defined as UACR of >/=30 mg/g but <300 mg/g in (>/=3.4mg/mmol but <34 mg/mmol) in 2 out of 3 first morning void samples and eGFR >/=30 mL/min/1.73 m² but < 90 mL/min/1.73m²
 - Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) for at least 3 months  without any adjustments to this therapy for at least 4 weeks prior to the screening visit
 - Serum potassium </= 4.8 mmol/L at both the run-in visit and the screening visit
Exclusion Criteria
- Non-diabetic renal disease
 - Glycated hemoglobin (HbA1c) >12% at the run-in visit or the screening visit
 - UACR >3000 mg/g (339mg/mmol) in any of the urinary first morning void samples at the run-in visit or screening visit
 - Hypertension with mean sitting systolic blood pressure (SBP) >/=180 mmHg or mean sitting diastolic blood pressure (DBP) >/=110 mmHg at the run-in visit or mean supine SBP >/=160 mmHg or mean sitting DBP >/=100 mmHg at the screening visit
 - Subjects with a clinical diagnosis of heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association class II-IV) at the run-in visit
 - Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic
 - Dialysis for acute renal failure within the previous 6 months prior to the run-in visit

Trial Summary

Enrollment Goal
823
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
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Investigative Site

Durban, South Africa, 4067

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Completed
 
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AMIENS, France, 80000

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Klipsruit West, South Africa, 1812

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Somerset West, South Africa, 7130

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Krugersdorp, South Africa, 1739

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Lenasia South, South Africa, 1829

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Newtown, South Africa, 2113

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Goodwood, South Africa, 7460

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Durban, South Africa, 4091

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Durban, South Africa, 4037

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Wien, Austria, 1130

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St. Pölten, Austria, 3100

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Graz, Austria, 3086

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Salzburg, Austria, 5020

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Salzburg, Austria, 5026

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Innsbruck, Austria, 6020

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Jerez de la Frontera, Spain, 11407

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Ferrol, Spain, 15405

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Merebank, South Africa, 4052

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Tongaat, South Africa, 4400

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Cape Town, South Africa, 7570

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Worcester, South Africa, 6850

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Sagunto, Spain, 46520

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Madrid, Spain, 28034

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Barcelona, Spain, 08025

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Miami, United States, 33015

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Girona, Spain, 17007

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Madrid, Spain, 28041

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Ålesund, Norway, 6026

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Bergamo, Italy, 24020

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Bergamo, Italy, 24127

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Milano, Italy, 20157

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Milano, Italy, 20134

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Napoli, Italy, 80131

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Padova, Italy, 35128

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Foggia, Italy, 71013

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Jerusalem, Israel, 9112001

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Ashkelon, Israel, 7830604

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Holon, Israel, 5822012

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Tel Aviv, Israel, 6203854

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Kfar Saba, Israel, 4428164

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Petach Tikva, Israel, 4941492

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Stockholm, Sweden, 141 86

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Stockholm, Sweden, 111 57

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Stockholm, Sweden, 113 24

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Vällingby, Sweden, 162 68

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Flint, United States, 48504

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Chula Vista, United States, 91910

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Los Gatos, United States, 95032

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New Haven, United States, 06510

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Los Angeles, United States, 90022

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Chicago, United States, 60612

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Chicago, United States, 60611

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Orangeburg, United States, 29118

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Dallas, United States, 75235-3858

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Burlington, United States, 05401

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Flushing, United States, 11355

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Birmingham, United States, 35294

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Pembroke Pines, United States, 33028

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Uppsala, Sweden, 753 19

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Örebro, Sweden, 701 85

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Karlstad, Sweden, 651 85

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Skövde, Sweden, 541 85

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Kristianstad, Sweden, 29185

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Tel Aviv, Israel, 6937947

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Hamar, Norway, 2326

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Aarhus C, Denmark, 8000

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Holstebro, Denmark, DK-7500

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Kolding, Denmark, 6000

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Gentofte, Denmark, 2820

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Herlev, Denmark, 2730

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Holbaek, Denmark, 4300

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Hillerød, Denmark, DK-3400

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Clayton, Australia, 3168

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Box Hill, Australia, 3128

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Reservoir, Australia, 3073

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Oulu, Finland, 90100

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Tampere, Finland, 33520

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Turku, Finland, 20520

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Helsinki, Finland, 00180

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Jyväskylä, Finland, 40620

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Cagliari, Italy, 09134

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Pisa, Italy, 56124

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Monza-Brianza, Italy, 20832

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Prahran, Australia, 3181

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Melbourne, Australia, 3052

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Woolloongabba, Australia, 4102

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Düsseldorf, Germany, 40210

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Neuwied, Germany, 56564

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Ludwigshafen, Germany, 67059

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Hannover, Germany, 30625

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Bad Oeynhausen, Germany, 32545

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Chattanooga, United States, 37408

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LYON CEDEX, France, 69437

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PARIS CEDEX 15, France, 75908

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LA TRONCHE, France, 38700

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Seoul, South Korea, 03722

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Busan, South Korea, 49241

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Seoul, South Korea, 06591

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Taipei, Taiwan, China, 10002

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Taipei, Taiwan, China, 11217

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Taipei, Taiwan, China, 110

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Kaohsiung, Taiwan, China, 833

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Debrecen, Hungary, 4032

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Eger, Hungary, 3300

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Nagykanizsa, Hungary, 8800

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Papa, Hungary, 8500

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Budapest, Hungary, 1085

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St Leonards, Australia, 2065

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GRONINGEN, Netherlands, 9713 GZ

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HOOGEVEEN, Netherlands, 7909 AA

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EINDHOVEN, Netherlands, 5600 PD

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Hong Kong, Hong Kong, China

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Shatin, Hong Kong, China

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Lisboa, Portugal, 1069-166

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Almada, Portugal, 2801-951

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Lisboa, Portugal, 1449-005

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Chrudim, Czech Republic, 537 01

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Sofia, Bulgaria, 1431

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Lodz, Poland, 90-153

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Wroclaw, Poland, 51-162

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Olawa, Poland, 55-200

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Bydgoszcz, Poland, 85-822

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Bialystok, Poland, 15-276

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Lublin, Poland, 20-081

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Warszawa, Poland

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Plovdiv, Bulgaria, 4002

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Lukovit, Bulgaria, 5770

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Haskovo, Bulgaria, 6300

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Stara Zagora, Bulgaria, 6000

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Varna, Bulgaria, 9010

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Varna, Bulgaria, 9000

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Ruse, Bulgaria, 7003

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Toronto, Canada, M4C 5T2

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Scarborough, Canada, M1H 3G4

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Montreal, Canada, H1T 2M4

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Vancouver, Canada, V5Z 1L8

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Courtice, Canada, L1E 3C3

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Toronto, Canada, M4N 3M5

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MAASTRICHT, Netherlands, 6229 HX

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AlMERE, Netherlands, 1311 RL

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Kitchener, Canada, N2H 5Z8

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Praha 2, Czech Republic, 12808

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Vancouver, Canada, V6E 1M7

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STRASBOURG, France, 67091

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Koprivnice, Czech Republic, 742 21

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Locations

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Krnov, Czech Republic, 794 01

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Completed
 

Trial Design