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
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
2 other identifiers
interventional
823
22 countries
140
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2013
Shorter than P25 for phase_2
140 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2013
CompletedFirst Posted
Study publicly available on registry
June 11, 2013
CompletedStudy Start
First participant enrolled
June 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 9, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2014
CompletedResults Posted
Study results publicly available
May 4, 2021
CompletedJuly 1, 2021
June 1, 2021
1.1 years
June 7, 2013
April 15, 2021
June 30, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Ratio of UACR at Day 90 to UACR at Baseline
Albumin-to-creatinine ratio (UACR) is defined as gram of albumin per kilogram of creatinine. UACR was calculating the average of 3 first morning void samples taken on 3 consecutive days.
Baseline and Day 90±2
Secondary Outcomes (4)
Change From Baseline to Day 90 in Serum Potassium
Baseline and Day 90±2
Change From Baseline to Day 90 in eGFR
Baseline and Day 90±2
Change From Baseline to Day 90 in KDQOL-36 Domain Score (Effects of Kidney Disease)
Baseline and Day 90±2
Change From Baseline to Day 90 in EQ-5D Scores (EQ5D - Visual Analog Scale)
Baseline and Day 90±2
Study Arms (8)
Finerenone (BAY94-8862) (1.25 mg)
EXPERIMENTAL1.25 mg dose oral once daily for 90 days
Finerenone (BAY94-8862)(2.5 mg)
EXPERIMENTAL2.5 mg dose oral once daily for 90 days
Finerenone (BAY94-8862)(5 mg)
EXPERIMENTAL5 mg dose oral once daily for 90 days
Finerenone (BAY94-8862)(7.5 mg)
EXPERIMENTAL7.5 mg dose oral once daily for 90 days
Finerenone (BAY94-8862) (10 mg)
EXPERIMENTAL10 mg dose oral once daily for 90 days
Finerenone (BAY94-8862) (15 mg)
EXPERIMENTAL15 mg dose oral once daily for 90 days
Finerenone (BAY94-8862)(20 mg)
EXPERIMENTAL20 mg dose oral once daily for 90 days
Placebo
PLACEBO COMPARATORPlacebo oral dose once daily for 90 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (147)
Unknown Facility
Birmingham, Alabama, 35294, United States
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Chula Vista, California, 91910, United States
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Los Angeles, California, 90022, United States
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Los Gatos, California, 95032, United States
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New Haven, Connecticut, 06510, United States
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Miami, Florida, 33015, United States
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Pembroke Pines, Florida, 33028, United States
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Chicago, Illinois, 60611, United States
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Chicago, Illinois, 60612, United States
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Flint, Michigan, 48504, United States
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Flushing, New York, 11355, United States
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Orangeburg, South Carolina, 29118, United States
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Chattanooga, Tennessee, 37408, United States
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Dallas, Texas, 75235-3858, United States
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Burlington, Vermont, 05401, United States
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St Leonards, New South Wales, 2065, Australia
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Clayton, Victoria, 3168, Australia
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Melbourne, Victoria, 3052, Australia
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Prahran, Victoria, 3181, Australia
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Reservoir, Victoria, 3073, Australia
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Box Hill, 3128, Australia
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Woolloongabba, 4102, Australia
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Graz, 3086, Austria
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Innsbruck, 6020, Austria
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Salzburg, 5020, Austria
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Salzburg, 5026, Austria
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Sankt Pölten, 3100, Austria
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Vienna, 1130, Austria
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Haskovo, 6300, Bulgaria
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Lukovit, 5770, Bulgaria
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Plovdiv, 4002, Bulgaria
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Rousse, 7003, Bulgaria
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Sofia, 1431, Bulgaria
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Stara Zagora, 6000, Bulgaria
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Varna, 9000, Bulgaria
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Varna, 9010, Bulgaria
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Vancouver, British Columbia, V5Z 1L8, Canada
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Vancouver, British Columbia, V6E 1M7, Canada
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Courtice, Ontario, L1E 3C3, Canada
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Kitchener, Ontario, N2H 5Z8, Canada
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Scarborough Village, Ontario, M1H 3G4, Canada
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Toronto, Ontario, M4C 5T2, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Chrudim, 537 01, Czechia
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Kopřivnice, 742 21, Czechia
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Krnov, 794 01, Czechia
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Prague, 12808, Czechia
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Aarhus C, 8000, Denmark
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Gentofte Municipality, 2820, Denmark
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Herlev, 2730, Denmark
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Hillerød, DK-3400, Denmark
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Holbæk, 4300, Denmark
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Holstebro, DK-7500, Denmark
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Kolding, 6000, Denmark
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Helsinki, 00180, Finland
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Jyväskylä, 40620, Finland
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Oulu, 90100, Finland
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Tampere, 33520, Finland
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Turku, 20520, Finland
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Amiens, 80000, France
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La Tronche, 38700, France
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Lyon, 69437, France
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Paris, 75908, France
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Strasbourg, 67091, France
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Hanover, Lower Saxony, 30625, Germany
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Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany
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Düsseldorf, North Rhine-Westphalia, 40210, Germany
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Ludwigshafen am Rhein, Rhineland-Palatinate, 67059, Germany
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Neuwied, Rhineland-Palatinate, 56564, Germany
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Hong Kong, Hong Kong
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Shatin, Hong Kong
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Budapest, 1085, Hungary
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Debrecen, 4032, Hungary
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Eger, 3300, Hungary
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Nagykanizsa, 8800, Hungary
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Pápa, 8500, Hungary
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Ashkelon, 7830604, Israel
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Holon, 5822012, Israel
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Jerusalem, 9112001, Israel
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Kfar Saba, 4428164, Israel
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Petah Tikva, 4941492, Israel
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Tel Aviv, 6203854, Israel
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Tel Aviv, 6937947, Israel
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Foggia, Apulia, 71013, Italy
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Napoli, Campania, 80131, Italy
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Bergamo, Lombardy, 24020, Italy
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Bergamo, Lombardy, 24127, Italy
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Milan, Lombardy, 20134, Italy
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Milan, Lombardy, 20157, Italy
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Monza-Brianza, Lombardy, 20832, Italy
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Cagliari, Sardinia, 09134, Italy
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Pisa, Tuscany, 56124, Italy
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Padua, Veneto, 35128, Italy
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Almere Stad, 1311 RL, Netherlands
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Eindhoven, 5600 PD, Netherlands
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Groningen, 9713 GZ, Netherlands
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Hoogeveen, 7909 AA, Netherlands
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Maastricht, 6229 HX, Netherlands
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Ålesund, 6026, Norway
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Hamar, 2326, Norway
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Bialystok, 15-276, Poland
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Bydgoszcz, 85-822, Poland
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Lodz, 90-153, Poland
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Lublin, 20-081, Poland
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Oława, 55-200, Poland
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Warsaw, Poland
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Wroclaw, 51-162, Poland
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Almada, 2801-951, Portugal
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Lisbon, 1069-166, Portugal
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Lisbon, 1449-005, Portugal
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Klipsruit West, Gauteng, 1812, South Africa
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Krugersdorp, Gauteng, 1739, South Africa
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Lenasia South, Gauteng, 1829, South Africa
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Newtown, Gauteng, 2113, South Africa
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Durban, KwaZulu-Natal, 4037, South Africa
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Durban, KwaZulu-Natal, 4067, South Africa
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Durban, KwaZulu-Natal, 4091, South Africa
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Merebank, KwaZulu-Natal, 4052, South Africa
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Tongaat, KwaZulu-Natal, 4400, South Africa
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Cape Town, Western Cape, 7570, South Africa
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Goodwood, Western Cape, 7460, South Africa
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Somerset West, Western Cape, 7130, South Africa
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Worcester, Western Cape, 6850, South Africa
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Busan, 49241, South Korea
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Seoul, 03722, South Korea
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Seoul, 06591, South Korea
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Ferrol, A Coruña, 15405, Spain
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Jerez de la Frontera, Cádiz, 11407, Spain
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Sagunto, Valencia, 46520, Spain
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Barcelona, 08025, Spain
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Girona, 17007, Spain
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Madrid, 28034, Spain
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Madrid, 28041, Spain
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Karlstad, 651 85, Sweden
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Kristianstad, 29185, Sweden
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Örebro, 701 85, Sweden
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Skövde, 541 85, Sweden
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Stockholm, 111 57, Sweden
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Stockholm, 113 24, Sweden
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Stockholm, 141 86, Sweden
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Uppsala, 753 19, Sweden
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Vällingby, 162 68, Sweden
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Kaohsiung City, 833, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 110, Taiwan
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Taipei, 11217, Taiwan
Related Publications (6)
Bakris GL, Agarwal R, Chan JC, Cooper ME, Gansevoort RT, Haller H, Remuzzi G, Rossing P, Schmieder RE, Nowack C, Kolkhof P, Joseph A, Pieper A, Kimmeskamp-Kirschbaum N, Ruilope LM; Mineralocorticoid Receptor Antagonist Tolerability Study-Diabetic Nephropathy (ARTS-DN) Study Group. Effect of Finerenone on Albuminuria in Patients With Diabetic Nephropathy: A Randomized Clinical Trial. JAMA. 2015 Sep 1;314(9):884-94. doi: 10.1001/jama.2015.10081.
PMID: 26325557RESULTSnelder N, Heinig R, Drenth HJ, Joseph A, Kolkhof P, Lippert J, Garmann D, Ploeger B, Eissing T. Population Pharmacokinetic and Exposure-Response Analysis of Finerenone: Insights Based on Phase IIb Data and Simulations to Support Dose Selection for Pivotal Trials in Type 2 Diabetes with Chronic Kidney Disease. Clin Pharmacokinet. 2020 Mar;59(3):359-370. doi: 10.1007/s40262-019-00820-x.
PMID: 31583611RESULTChung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.
PMID: 33107592RESULTOstrominski JW, Filippatos G, Claggett BL, Miao ZM, Desai AS, Jhund PS, Henderson A, Rohwedder K, Brinker MD, Scalise A, Schloemer P, Lam CSP, Senni M, Shah SJ, Voors AA, Zannad F, Rossing P, Ruilope LM, Anker SD, Pitt B, Agarwal R, McMurray JJV, Solomon SD, Vaduganathan M. Effect of Finerenone on Morbidity and Mortality in CKD. J Am Soc Nephrol. 2025 Sep 12. doi: 10.1681/ASN.0000000823. Online ahead of print. No abstract available.
PMID: 40938666DERIVEDAgarwal R, Ruilope LM, Ruiz-Hurtado G, Haller H, Schmieder RE, Anker SD, Filippatos G, Pitt B, Rossing P, Lambelet M, Nowack C, Kolkhof P, Joseph A, Bakris GL. Effect of finerenone on ambulatory blood pressure in chronic kidney disease in type 2 diabetes. J Hypertens. 2023 Feb 1;41(2):295-302. doi: 10.1097/HJH.0000000000003330. Epub 2022 Dec 8.
PMID: 36583355DERIVEDErraez S, Lopez-Mesa M, Gomez-Fernandez P. Mineralcorticoid receptor blockers in chronic kidney disease. Nefrologia (Engl Ed). 2021 May-Jun;41(3):258-275. doi: 10.1016/j.nefro.2020.10.001. Epub 2020 Dec 24. English, Spanish.
PMID: 33358451DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer AG
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2013
First Posted
June 11, 2013
Study Start
June 12, 2013
Primary Completion
July 9, 2014
Study Completion
August 7, 2014
Last Updated
July 1, 2021
Results First Posted
May 4, 2021
Record last verified: 2021-06