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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01874431
First received: June 7, 2013
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Diabetic Nephropathies
Drug: Finerenone (BAY 94-8862)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Change of urinary albumin-to-creatinine ratio [ Time Frame: From baseline to 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in serum potassium [ Time Frame: 7 days, 30 days, 60 days, 90 days ] [ Designated as safety issue: Yes ]
  • Change in renal function [ Time Frame: 30 days, 60 days, 90 days ] [ Designated as safety issue: Yes ]
  • Change in health-related quality of life [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Health-related quality of life is assessed by the scores got from the Kidney Disease Quality of Life (KDQOL-36) and EuroQol Group 5 dimension, 3 level (EQ-5D-3L) questionnaires.

  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 120 days ] [ Designated as safety issue: Yes ]

Enrollment: 821
Study Start Date: June 2013
Study Completion Date: August 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Finerenone (BAY 94-8862) (1.25 mg)
1.25 mg dose oral once daily for 90 days
Drug: Finerenone (BAY 94-8862)
Experimental: Finerenone (BAY 94-8862)(2.5 mg)
2.5 mg dose oral once daily for 90 days
Drug: Finerenone (BAY 94-8862)
Experimental: Finerenone (BAY 94-8862)(5 mg)
5 mg dose oral once daily for 90 days
Drug: Finerenone (BAY 94-8862)
Experimental: Finerenone (BAY 94-8862)(7.5 mg)
7.5 mg dose oral once daily for 90 days
Drug: Finerenone (BAY 94-8862)
Experimental: Finerenone (BAY 94-8862) (10 mg)
10 mg dose oral once daily for 90 days
Drug: Finerenone (BAY 94-8862)
Experimental: Finerenone (BAY 94-8862) (15 mg)
15 mg dose oral once daily for 90 days
Drug: Finerenone (BAY 94-8862)
Experimental: Finerenone (BAY 94-8862)(20 mg)
20 mg dose oral once daily for 90 days
Drug: Finerenone (BAY 94-8862)
Placebo Comparator: Placebo
Placebo oral dose once daily for 90 days
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01874431

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35294
United States, California
Chula Vista, California, United States, 91910
Los Angeles, California, United States, 90022
Los Gatos, California, United States, 95032
United States, Connecticut
New Haven, Connecticut, United States, 06510
United States, Florida
Miami, Florida, United States, 33015
Pembroke Pines, Florida, United States, 33028
United States, Illinois
Chicago, Illinois, United States, 60612
Chicago, Illinois, United States, 60611
United States, Michigan
Flint, Michigan, United States, 48504
United States, New York
Flushing, New York, United States, 11355
United States, South Carolina
Orangeburg, South Carolina, United States, 29118
United States, Tennessee
Chattanooga, Tennessee, United States, 37408
United States, Texas
Dallas, Texas, United States, 75235-3858
Houston, Texas, United States, 77054
United States, Vermont
Burlington, Vermont, United States, 05401
Australia, New South Wales
St Leonards, New South Wales, Australia, 2065
Australia, Victoria
Clayton, Victoria, Australia, 3168
Melbourne, Victoria, Australia, 3052
Prahran, Victoria, Australia, 3181
Australia
Box Hill, Australia, 3128
Reservoir, Australia, 3073
Woolloongabba, Australia, 4102
Austria
Graz, Austria, 3086
Innsbruck, Austria, 6020
Salzburg, Austria, 5020
Salzburg, Austria, 5026
St. Pölten, Austria, 3100
Wien, Austria, 1030
Wien, Austria, 1090
Wien, Austria, 1130
Bulgaria
Haskovo, Bulgaria, 6300
Lukovit, Bulgaria, 5770
Plovdiv, Bulgaria, 4002
Ruse, Bulgaria, 7003
Sofia, Bulgaria, 1431
Stara Zagora, Bulgaria, 6000
Varna, Bulgaria, 9000
Varna, Bulgaria, 9010
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1L8
Vancouver, British Columbia, Canada, V6E 1M7
Canada, Ontario
Courtice, Ontario, Canada, L1E 3C3
Kitchener, Ontario, Canada, N2H 5Z8
Scarborough, Ontario, Canada, M1H 3G4
Toronto, Ontario, Canada, M4C 5T2
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Montreal, Quebec, Canada, H1T 2M4
Canada
Quebec, Canada, G1R 2J6
Czech Republic
Bilovec, Czech Republic, 74301
Chrudim, Czech Republic, 537 01
Koprivnice, Czech Republic, 742 21
Krnov, Czech Republic, 794 01
Praha 2, Czech Republic, 12808
Praha 4, Czech Republic, 149 00
Praha 4, Czech Republic, 140 21
Denmark
Aarhus C, Denmark, 8000
Gentofte, Denmark, 2820
Herlev, Denmark, 2730
Hillerød, Denmark, DK-3400
Holbaek, Denmark, 4300
Holstebro, Denmark, DK-7500
Kolding, Denmark, 6000
Køge, Denmark, DK-4600
Finland
Helsinki, Finland, 00180
Jyväskylä, Finland, 40620
Oulu, Finland, 90100
Tampere, Finland, 33520
Turku, Finland, 20520
France
Amiens, France, 80000
La Tronche, France, 38700
Lyon Cedex, France, 69437
Paris Cedex 15, France, 75908
Reims, France, 51092
Strasbourg, France, 67091
Germany
Heidelberg, Baden-Württemberg, Germany, 69120
Hannover, Niedersachsen, Germany, 30625
Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
Düsseldorf, Nordrhein-Westfalen, Germany, 40210
Ludwigshafen, Rheinland-Pfalz, Germany, 67059
Neuwied, Rheinland-Pfalz, Germany, 56564
Magdeburg, Sachsen-Anhalt, Germany, 39120
Hong Kong
Hong Kong, Hong Kong
Shatin, Hong Kong
Hungary
Budapest, Hungary, 1085
Budapest, Hungary, 1212
Debrecen, Hungary, 4032
Eger, Hungary, 3301
Nagykanizsa, Hungary, 8800
Papa, Hungary, 8500
Israel
Ashkelon, Israel, 7830604
Hadera, Israel, 3810101
Holon, Israel, 58100
Jerusalem, Israel, 9112001
Kfar Saba, Israel, 4428164
Petach Tikva, Israel, 4941492
Tel Aviv, Israel, 6937947
Tel Aviv, Israel, 62038
Tel Hashomer, Israel, 5262000
Italy
Ranica, Bergamo, Italy, 24020
Bollate, Milano, Italy, 20134
Bergamo, Italy, 24127
Cagliari, Italy, 09134
Desio, Italy, 20832
Milano, Italy, 20157
Napoli, Italy, 80131
Padova, Italy, 35128
Pisa, Italy, 56124
San Giovanni Rotondo, Italy, 71013
Treviglio, Italy, 24047
Korea, Republic of
Busan, Korea, Republic of, 602-739
Seoul, Korea, Republic of, 137-701
Seoul, Korea, Republic of, 120-752
Netherlands
AlMERE, Netherlands, 1311 RL
Eindhoven, Netherlands, 5600 PD
Groningen, Netherlands, 9713 GZ
Hoogeveen, Netherlands, 7909 AA
Maastricht, Netherlands, 6229 HX
Norway
Hamar, Norway, 2326
Ålesund, Norway, 6026
Poland
Bialystok, Poland, 15-276
Bydgoszcz, Poland, 85-822
Lodz, Poland, 90-153
Lodz, Poland, 90-752
Lublin, Poland, 20-081
Olawa, Poland, 55-200
Olsztyn, Poland, 10-561
Warszawa, Poland
Wroclaw, Poland, 51-162
Portugal
Almeda, Portugal, 2801-951
Coimbra, Portugal, 3000-075
Faro, Portugal, 8000-386
Lisboa, Portugal, 1069-166
Lisboa, Portugal, 1449-005
Lisboa, Portugal, 1500-650
South Africa
Klipsruit West, Gauteng, South Africa, 1812
Krugersdorp, Gauteng, South Africa, 1739
Lenasia South, Gauteng, South Africa, 1829
Newtown, Gauteng, South Africa, 2113
Parktown, Gauteng, South Africa
Durban, KwaZulu Natal, South Africa, 4091
Durban, KwaZulu Natal, South Africa, 4037
Durban, Kwazulu-Natal, South Africa, 4067
Merebank, Kwazulu-Natal, South Africa, 4052
Tongaat, Kwazulu-Natal, South Africa, 4400
Cape Town, Western Cape, South Africa, 7570
Goodwood, Western Cape, South Africa, 7460
Somerset West, Western Cape, South Africa, 7130
Worcester, Western Cape, South Africa, 6850
Spain
Ferrol, A Coruña, Spain, 15405
Jerez de la Frontera, Cádiz, Spain, 11407
Sagunto, Valencia, Spain, 46520
Barcelona, Spain, 08025
Girona, Spain, 17007
Madrid, Spain, 28034
Madrid, Spain, 28041
Sweden
Karlstad, Sweden, 651 85
Kristianstad, Sweden, 29185
Skövde, Sweden, 541 85
Stockholm, Sweden, 141 86
Stockholm, Sweden, 111 57
Stockholm, Sweden, 113 61
Uppsala, Sweden, 753 19
Vällingby, Sweden, 162 68
Örebro, Sweden, 701 85
Taiwan
Kaohsiung, Taiwan, 833
Taipei, Taiwan, 11217
Taipei, Taiwan, 110
Taipei, Taiwan, 100
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01874431     History of Changes
Other Study ID Numbers: 16243, 2012-004179-38
Study First Received: June 7, 2013
Last Updated: August 14, 2014
Health Authority: Austria: Austrian Medicines and Medical Devices Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Health and Medicines Authority
Finland: Finnish Medicines Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: INFARMED - National Authority of Medicines and Health Products
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Taiwan : Food and Drug Administration
United States: Food and Drug Administration
Bulgaria: Bulgarian Drug Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Diabetic Nephropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on September 30, 2014