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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
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Locations Investigative Site Durban, South Africa, 4067 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site AMIENS, France, 80000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Klipsruit West, South Africa, 1812 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Somerset West, South Africa, 7130 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Krugersdorp, South Africa, 1739 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lenasia South, South Africa, 1829 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Newtown, South Africa, 2113 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Goodwood, South Africa, 7460 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Durban, South Africa, 4091 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Durban, South Africa, 4037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1130 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Pölten, Austria, 3100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Graz, Austria, 3086 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Salzburg, Austria, 5020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Salzburg, Austria, 5026 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Innsbruck, Austria, 6020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jerez de la Frontera, Spain, 11407 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ferrol, Spain, 15405 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Merebank, South Africa, 4052 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tongaat, South Africa, 4400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cape Town, South Africa, 7570 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Worcester, South Africa, 6850 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sagunto, Spain, 46520 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28034 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Ålesund, Norway, 6026 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bergamo, Italy, 24020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bergamo, Italy, 24127 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20157 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20134 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Padova, Italy, 35128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Foggia, Italy, 71013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jerusalem, Israel, 9112001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ashkelon, Israel, 7830604 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Holon, Israel, 5822012 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tel Aviv, Israel, 6203854 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kfar Saba, Israel, 4428164 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Petach Tikva, Israel, 4941492 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stockholm, Sweden, 141 86 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stockholm, Sweden, 111 57 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stockholm, Sweden, 113 24 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vällingby, Sweden, 162 68 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Flint, United States, 48504 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chula Vista, United States, 91910 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Orangeburg, United States, 29118 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dallas, United States, 75235-3858 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Burlington, United States, 05401 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Flushing, United States, 11355 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Birmingham, United States, 35294 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pembroke Pines, United States, 33028 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Uppsala, Sweden, 753 19 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Örebro, Sweden, 701 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Karlstad, Sweden, 651 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Skövde, Sweden, 541 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kristianstad, Sweden, 29185 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tel Aviv, Israel, 6937947 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamar, Norway, 2326 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aarhus C, Denmark, 8000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Holstebro, Denmark, DK-7500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kolding, Denmark, 6000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gentofte, Denmark, 2820 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Herlev, Denmark, 2730 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Holbaek, Denmark, 4300 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hillerød, Denmark, DK-3400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Clayton, Australia, 3168 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Box Hill, Australia, 3128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Reservoir, Australia, 3073 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oulu, Finland, 90100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tampere, Finland, 33520 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Turku, Finland, 20520 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Helsinki, Finland, 00180 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jyväskylä, Finland, 40620 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cagliari, Italy, 09134 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pisa, Italy, 56124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Monza-Brianza, Italy, 20832 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Prahran, Australia, 3181 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Melbourne, Australia, 3052 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Woolloongabba, Australia, 4102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Düsseldorf, Germany, 40210 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Neuwied, Germany, 56564 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ludwigshafen, Germany, 67059 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hannover, Germany, 30625 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bad Oeynhausen, Germany, 32545 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chattanooga, United States, 37408 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LYON CEDEX, France, 69437 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS CEDEX 15, France, 75908 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LA TRONCHE, France, 38700 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 03722 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Busan, South Korea, 49241 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 06591 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei, Taiwan, China, 10002 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Kaohsiung, Taiwan, China, 833 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Debrecen, Hungary, 4032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Eger, Hungary, 3300 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagykanizsa, Hungary, 8800 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Papa, Hungary, 8500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Budapest, Hungary, 1085 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St Leonards, Australia, 2065 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site GRONINGEN, Netherlands, 9713 GZ | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Hong Kong, Hong Kong, China | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Lisboa, Portugal, 1069-166 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Locations Investigative Site Lisboa, Portugal, 1449-005 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chrudim, Czech Republic, 537 01 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sofia, Bulgaria, 1431 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lodz, Poland, 90-153 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wroclaw, Poland, 51-162 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Olawa, Poland, 55-200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bydgoszcz, Poland, 85-822 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bialystok, Poland, 15-276 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lublin, Poland, 20-081 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warszawa, Poland | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Plovdiv, Bulgaria, 4002 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lukovit, Bulgaria, 5770 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Haskovo, Bulgaria, 6300 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stara Zagora, Bulgaria, 6000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Varna, Bulgaria, 9010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Varna, Bulgaria, 9000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ruse, Bulgaria, 7003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M4C 5T2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Scarborough, Canada, M1H 3G4 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Montreal, Canada, H1T 2M4 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vancouver, Canada, V5Z 1L8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Courtice, Canada, L1E 3C3 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M4N 3M5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MAASTRICHT, Netherlands, 6229 HX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site AlMERE, Netherlands, 1311 RL | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kitchener, Canada, N2H 5Z8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 2, Czech Republic, 12808 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vancouver, Canada, V6E 1M7 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site STRASBOURG, France, 67091 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Koprivnice, Czech Republic, 742 21 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Krnov, Czech Republic, 794 01 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
8
Primary Outcome
- Ratio of UACR at Day 90 to UACR at baselineAlbumin-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.Timeframe: Baseline and Day 90±2
Secondary Outcome
- Change from baseline to Day 90 in serum potassiumTimeframe: Baseline and Day 90±2
- Change from baseline to Day 90 in eGFRAn estimated glomerular filtration rate (eGFR) indicates the renal function. An eGFR was calculated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.Timeframe: Baseline and Day 90±2
- Change from baseline to Day 90 in KDQOL-36 domain score (Effects of Kidney Disease)The Kidney Disease QOL [KDQOL]-36 questionnaire is a specific measure of Health-Related Quality of Life (HRQoL) for chronic kidney disease (CKD) that includes effects and burden of kidney disease as well as physical and mental health scores. Index score ranges from 0 (severe problems in all items) to 100 (no problem in all items). "Effects of Kidney disease" subscore was analyzed.Timeframe: Baseline and Day 90±2
- Change from baseline to Day 90 in EQ-5D scores (EQ5D - Visual Analog Scale)EuroQol Group 5-Dimension, 3-Level (EQ-5D-3L) questionnaires consist of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. EQ VAS was analyzed for this endpoint and it ranges from 0 (worst possible health state) to 100 (best possible health state).Timeframe: Baseline and Day 90±2
Additional Information
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