ID

39080

Description

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); ODM derived from: https://clinicaltrials.gov/show/NCT01968668

Link

https://clinicaltrials.gov/show/NCT01968668

Keywords

Versions (1)
  1. 11/28/19 11/28/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 28, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetic Nephropathies NCT01968668

English

Eligibility Diabetic Nephropathies NCT01968668

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
japanese subjects with type 2 diabetes mellitus and a clinical diagnosis of dn (diabetic nephropathy) treated with at least the minimal recommended dose of an angiotensin converting enzyme inhibitor (acei) and/or angiotensin receptor blocker (arb)
Description

Japanese | Diabetes Mellitus, Non-Insulin-Dependent | Diabetic Nephropathy | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist

Data type

boolean

Alias
UMLS CUI [1]
C1556094
UMLS CUI [2]
C0011860
UMLS CUI [3]
C0011881
UMLS CUI [4]
C0003015
UMLS CUI [5]
C0521942
subjects with a clinical diagnosis of diabetic nephropathy (dn) based on at least 1 of the following criteria:
Description

Diabetic Nephropathy

Data type

boolean

Alias
UMLS CUI [1]
C0011881
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
Description

Persistent albuminuria Very high | Urine albumin/creatinine ratio measurement | Estimated Glomerular Filtration Rate | Creatinine-based formula (CKD-EPI)

Data type

boolean

Alias
UMLS CUI [1,1]
C4546070
UMLS CUI [1,2]
C0442804
UMLS CUI [2]
C0455271
UMLS CUI [3]
C3811844
UMLS CUI [4]
C2964649
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)
Description

Persistent albuminuria High | Urine albumin/creatinine ratio measurement | Estimated Glomerular Filtration Rate | Creatinine-based formula (CKD-EPI)

Data type

boolean

Alias
UMLS CUI [1,1]
C4546070
UMLS CUI [1,2]
C0205250
UMLS CUI [2]
C0455271
UMLS CUI [3]
C3811844
UMLS CUI [4]
C2964649
serum potassium </=4.8 mmol/l at both the run-in visit and the screening visit
Description

Serum potassium measurement

Data type

boolean

Alias
UMLS CUI [1]
C0302353
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
non-diabetic renal disease (confirmed by biopsy)
Description

Kidney Disease | Exception Diabetic Nephropathy

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0011881
known bilateral clinically relevant renal artery stenosis (>75%)
Description

Bilateral renal artery stenosis Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C0856760
UMLS CUI [1,2]
C0439165
glycated hemoglobin(hba1c) >12% at the run-in visit or the screening visit
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
uacr >3000 mg/g (339 mg/mmol) in any of the urinary first morning void samples at the run-in visit or screening visit
Description

Urine albumin/creatinine ratio measurement

Data type

boolean

Alias
UMLS CUI [1]
C0455271
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
Description

Hypertensive disease | Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C1319894
UMLS CUI [3,2]
C0444504
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
Description

Heart failure with reduced ejection fraction | Symptoms Persistent | New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C3839346
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0205322
UMLS CUI [3]
C1275491
concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic
Description

eplerenone | Spironolactone | Renin inhibitor | Potassium Sparing Diuretics

Data type

boolean

Alias
UMLS CUI [1]
C0961485
UMLS CUI [2]
C0037982
UMLS CUI [3]
C1960108
UMLS CUI [4]
C0304490
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Similar models

Eligibility Diabetic Nephropathies NCT01968668

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Japanese | Diabetes Mellitus, Non-Insulin-Dependent | Diabetic Nephropathy | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist
Item
japanese subjects with type 2 diabetes mellitus and a clinical diagnosis of dn (diabetic nephropathy) treated with at least the minimal recommended dose of an angiotensin converting enzyme inhibitor (acei) and/or angiotensin receptor blocker (arb)
boolean
C1556094 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0011881 (UMLS CUI [3])
C0003015 (UMLS CUI [4])
C0521942 (UMLS CUI [5])
Diabetic Nephropathy
Item
subjects with a clinical diagnosis of diabetic nephropathy (dn) based on at least 1 of the following criteria:
boolean
C0011881 (UMLS CUI [1])
Persistent albuminuria Very high | Urine albumin/creatinine ratio measurement | Estimated Glomerular Filtration Rate | Creatinine-based formula (CKD-EPI)
Item
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
boolean
C4546070 (UMLS CUI [1,1])
C0442804 (UMLS CUI [1,2])
C0455271 (UMLS CUI [2])
C3811844 (UMLS CUI [3])
C2964649 (UMLS CUI [4])
Persistent albuminuria High | Urine albumin/creatinine ratio measurement | Estimated Glomerular Filtration Rate | Creatinine-based formula (CKD-EPI)
Item
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)
boolean
C4546070 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
C0455271 (UMLS CUI [2])
C3811844 (UMLS CUI [3])
C2964649 (UMLS CUI [4])
Serum potassium measurement
Item
serum potassium </=4.8 mmol/l at both the run-in visit and the screening visit
boolean
C0302353 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Kidney Disease | Exception Diabetic Nephropathy
Item
non-diabetic renal disease (confirmed by biopsy)
boolean
C0022658 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0011881 (UMLS CUI [2,2])
Bilateral renal artery stenosis Percentage
Item
known bilateral clinically relevant renal artery stenosis (>75%)
boolean
C0856760 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
glycated hemoglobin(hba1c) >12% at the run-in visit or the screening visit
boolean
C0474680 (UMLS CUI [1])
Urine albumin/creatinine ratio measurement
Item
uacr >3000 mg/g (339 mg/mmol) in any of the urinary first morning void samples at the run-in visit or screening visit
boolean
C0455271 (UMLS CUI [1])
Hypertensive disease | Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean
Item
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
boolean
C0020538 (UMLS CUI [1])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319894 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Heart failure with reduced ejection fraction | Symptoms Persistent | New York Heart Association Classification
Item
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
boolean
C3839346 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C0205322 (UMLS CUI [2,2])
C1275491 (UMLS CUI [3])
eplerenone | Spironolactone | Renin inhibitor | Potassium Sparing Diuretics
Item
concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic
boolean
C0961485 (UMLS CUI [1])
C0037982 (UMLS CUI [2])
C1960108 (UMLS CUI [3])
C0304490 (UMLS CUI [4])
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