Safety and Efficacy of Different Oral Doses of BAY94-8862 in Japanese Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy (ARTS-DN Japan)
NCT ID: NCT01968668
Last Updated: 2021-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
96 participants
INTERVENTIONAL
2013-10-28
2014-11-07
Brief Summary
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Primary objective of the study is investigate the change of Urinary Albumin to Creatine Ratio (UACR) after treatment with different oral doses of BAY94-8862 given once daily from baseline to Visit 8 (Day 90)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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BAY94-8862 (1.25 mg)
BAY94-8862
1.25 mg BAY94-8862 tablet once daily in the morning
BAY94-8862 (2.5 mg)
BAY94-8862
2.5 mg BAY94-8862 tablet once daily in the morning
BAY94-8862 (5 mg )
BAY94-8862
5 mg BAY94-8862 tablet once daily in the morning
BAY94-8862 (7.5 mg)
BAY94-8862
7.5 mg BAY94-8862 tablet once daily in the morning
BAY94-8862 (10 mg)
BAY94-8862
10 mg BAY94-8862 tablet once daily in the morning
Placebo
Placebo
Placebo tablet once daily in the morning
BAY 94-8862 (15 mg)
BAY 94-8862
15 mg BAY 94-8862 tablet once daily in the morning
BAY 94-8862 (20 mg)
BAY 94-8862
20 mg BAY 94-8862 tablet once daily in the morning
Interventions
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BAY94-8862
1.25 mg BAY94-8862 tablet once daily in the morning
BAY94-8862
2.5 mg BAY94-8862 tablet once daily in the morning
BAY94-8862
5 mg BAY94-8862 tablet once daily in the morning
BAY94-8862
7.5 mg BAY94-8862 tablet once daily in the morning
BAY94-8862
10 mg BAY94-8862 tablet once daily in the morning
Placebo
Placebo tablet once daily in the morning
BAY 94-8862
15 mg BAY 94-8862 tablet once daily in the morning
BAY 94-8862
20 mg BAY 94-8862 tablet once daily in the morning
Eligibility Criteria
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Inclusion Criteria
* 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/1.73 m2 Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) or
* Persistent high albuminuria defined as UACR of \>/=30 mg/g but \<300 mg/g (\>/=3.4 mg/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/1.73 m2 (CKD-EPI)
* Serum potassium \</=4.8 mmol/L at both the run-in visit and the screening visit
Exclusion Criteria
* Known bilateral clinically relevant renal artery stenosis (\>75%)
* Glycated hemoglobin(HbA1c) \>12% at the run-in visit or the screening visit
* UACR \>3000 mg/g (339 mg/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 sitting 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
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Nagoya, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Saijō, Ehime, Japan
Kurume, Fukuoka, Japan
Kurume, Fukuoka, Japan
Obihiro, Hokkaido, Japan
Amagasaki, Hyōgo, Japan
Koga, Ibaraki, Japan
Tsuchiura, Ibaraki, Japan
Tsukuba, Ibaraki, Japan
Kahoku-gun, Ishikawa-ken, Japan
Sakaidechō, Kagawa-ken, Japan
Izumisano, Osaka, Japan
Yao, Osaka, Japan
Katsushika-ku, Tokyo, Japan
Osaka, , Japan
Countries
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References
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Snelder 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.
Related Links
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Click here to find results for studies related to Bayer Healthcare products.
Other Identifiers
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16816
Identifier Type: -
Identifier Source: org_study_id
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