ID

20015

Description

The Canadian Prevention of Renal and Cardiovascular Endpoints Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00231803

Link

https://clinicaltrials.gov/show/NCT00231803

Keywords

Versions (1)
  1. 2/3/17 2/3/17 -
Uploaded on

February 3, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Kidney Disease NCT00231803

English

Eligibility Chronic Kidney Disease NCT00231803

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
stratum 1 (expected about 50% of trial subjects): diabetes mellitus (by clinical history with documented prior plasma glucose levels in the diabetic range, or on hypoglycemic medications) and ckd as documented by calculated (cockroft-gault equation) creatinine clearance between 25 and 60 mls/min/1.73m2 derived from the screening serum creatinine value and the next most recent known value from more than 2 weeks prior; or
Description

Diabetes Mellitus | Plasma glucose result Range Diabetic | Hypoglycemic Agents | Chronic Kidney Diseases | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2,1]
C0455280
UMLS CUI [2,2]
C1514721
UMLS CUI [2,3]
C0241863
UMLS CUI [3]
C0020616
UMLS CUI [4]
C1561643
UMLS CUI [5]
C2711451
UMLS CUI [6]
C0201976
stratum 2 (expected about 20% of trial subjects): non-diabetic with ckd as defined for stratum 1 and proteinuria of > 1g/l by dipstick in random urine at screening; or
Description

Diabetic Absent | Chronic Kidney Disease | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine measurement, serum | Proteinuria Urine dipstick test

Data type

boolean

Alias
UMLS CUI [1,1]
C0241863
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C1561643
UMLS CUI [3]
C2711451
UMLS CUI [4]
C0201976
UMLS CUI [5,1]
C0033687
UMLS CUI [5,2]
C0430370
stratum 3 (expected about 30% of trial subjects): non-diabetic with ckd as defined for stratum 1, but without proteinuria as for stratum 2 at screening
Description

Diabetic Absent | Chronic Kidney Disease | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine measurement, serum | Proteinuria Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0241863
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C1561643
UMLS CUI [3]
C2711451
UMLS CUI [4]
C0201976
UMLS CUI [5,1]
C0033687
UMLS CUI [5,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
unwilling to provide informed consent
Description

Informed Consent Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
likely to die of any known existing disease within 6 months
Description

Cessation of life Probably | Death caused by Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C0750492
UMLS CUI [2,1]
C0011065
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0012634
recently unstable/advanced cardiovascular disease (mi or acute coronary syndrome, hospitalized heart failure, tia or stroke, leg amputation or gangrene in past 6 months)
Description

Cardiovascular Disease Unstable | Cardiovascular Disease Advanced | Myocardial Infarction | Acute Coronary Syndrome | Hospitalization Due to Heart failure | Transient Ischemic Attack | Cerebrovascular accident | Amputation of lower limb | Gangrene

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0205179
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0948089
UMLS CUI [5,1]
C0019993
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C0018801
UMLS CUI [6]
C0007787
UMLS CUI [7]
C0038454
UMLS CUI [8]
C0337308
UMLS CUI [9]
C0017086
currently receiving active treatment for a malignant, neoplastic disease other than localized non-melanoma skin cancer
Description

cancer treatment | Skin carcinoma Localized

Data type

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2,1]
C0699893
UMLS CUI [2,2]
C0392752
progressive kidney disease currently treated by immunotherapy
Description

Immunotherapy RENAL DISEASE PROGRESSIVE

Data type

boolean

Alias
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C0748293
currently receiving dialysis or likely to do so within 6 months
Description

Dialysis procedure | Dialysis procedure Probably

Data type

boolean

Alias
UMLS CUI [1]
C0011946
UMLS CUI [2,1]
C0011946
UMLS CUI [2,2]
C0750492
current organ transplant recipient (or planned within 6 months)
Description

Transplanted organ Recipient | Transplanted organ Recipient Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0524930
UMLS CUI [1,2]
C1709854
UMLS CUI [2,1]
C0524930
UMLS CUI [2,2]
C1709854
UMLS CUI [2,3]
C1301732
currently receiving ongoing care for ckd, or cardiovascular disease, in a multiple intervention, disease management program.
Description

Medical care Chronic Kidney Disease | Medical care Cardiovascular Disease | Intervention multiple | Disease management program

Data type

boolean

Alias
UMLS CUI [1,1]
C0496675
UMLS CUI [1,2]
C1561643
UMLS CUI [2,1]
C0496675
UMLS CUI [2,2]
C0007222
UMLS CUI [3,1]
C0184661
UMLS CUI [3,2]
C0439064
UMLS CUI [4]
C1303150
currently enrolled in another interventional trial
Description

Study Subject Participation Status | Enrollment Interventional Study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1516879
UMLS CUI [2,2]
C3274035
residing in a location not amenable to follow up for the trial
Description

Living place Amenable Clinical Study Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0337646
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C3274571
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Similar models

Eligibility Chronic Kidney Disease NCT00231803

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus | Plasma glucose result Range Diabetic | Hypoglycemic Agents | Chronic Kidney Diseases | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine measurement, serum
Item
stratum 1 (expected about 50% of trial subjects): diabetes mellitus (by clinical history with documented prior plasma glucose levels in the diabetic range, or on hypoglycemic medications) and ckd as documented by calculated (cockroft-gault equation) creatinine clearance between 25 and 60 mls/min/1.73m2 derived from the screening serum creatinine value and the next most recent known value from more than 2 weeks prior; or
boolean
C0011849 (UMLS CUI [1])
C0455280 (UMLS CUI [2,1])
C1514721 (UMLS CUI [2,2])
C0241863 (UMLS CUI [2,3])
C0020616 (UMLS CUI [3])
C1561643 (UMLS CUI [4])
C2711451 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Diabetic Absent | Chronic Kidney Disease | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine measurement, serum | Proteinuria Urine dipstick test
Item
stratum 2 (expected about 20% of trial subjects): non-diabetic with ckd as defined for stratum 1 and proteinuria of > 1g/l by dipstick in random urine at screening; or
boolean
C0241863 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1561643 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C0033687 (UMLS CUI [5,1])
C0430370 (UMLS CUI [5,2])
Diabetic Absent | Chronic Kidney Disease | Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine measurement, serum | Proteinuria Absent
Item
stratum 3 (expected about 30% of trial subjects): non-diabetic with ckd as defined for stratum 1, but without proteinuria as for stratum 2 at screening
boolean
C0241863 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1561643 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C0033687 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unwilling
Item
unwilling to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Cessation of life Probably | Death caused by Disease
Item
likely to die of any known existing disease within 6 months
boolean
C0011065 (UMLS CUI [1,1])
C0750492 (UMLS CUI [1,2])
C0011065 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0012634 (UMLS CUI [2,3])
Cardiovascular Disease Unstable | Cardiovascular Disease Advanced | Myocardial Infarction | Acute Coronary Syndrome | Hospitalization Due to Heart failure | Transient Ischemic Attack | Cerebrovascular accident | Amputation of lower limb | Gangrene
Item
recently unstable/advanced cardiovascular disease (mi or acute coronary syndrome, hospitalized heart failure, tia or stroke, leg amputation or gangrene in past 6 months)
boolean
C0007222 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0948089 (UMLS CUI [4])
C0019993 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0018801 (UMLS CUI [5,3])
C0007787 (UMLS CUI [6])
C0038454 (UMLS CUI [7])
C0337308 (UMLS CUI [8])
C0017086 (UMLS CUI [9])
cancer treatment | Skin carcinoma Localized
Item
currently receiving active treatment for a malignant, neoplastic disease other than localized non-melanoma skin cancer
boolean
C0920425 (UMLS CUI [1])
C0699893 (UMLS CUI [2,1])
C0392752 (UMLS CUI [2,2])
Immunotherapy RENAL DISEASE PROGRESSIVE
Item
progressive kidney disease currently treated by immunotherapy
boolean
C0021083 (UMLS CUI [1,1])
C0748293 (UMLS CUI [1,2])
Dialysis procedure | Dialysis procedure Probably
Item
currently receiving dialysis or likely to do so within 6 months
boolean
C0011946 (UMLS CUI [1])
C0011946 (UMLS CUI [2,1])
C0750492 (UMLS CUI [2,2])
Transplanted organ Recipient | Transplanted organ Recipient Planned
Item
current organ transplant recipient (or planned within 6 months)
boolean
C0524930 (UMLS CUI [1,1])
C1709854 (UMLS CUI [1,2])
C0524930 (UMLS CUI [2,1])
C1709854 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Medical care Chronic Kidney Disease | Medical care Cardiovascular Disease | Intervention multiple | Disease management program
Item
currently receiving ongoing care for ckd, or cardiovascular disease, in a multiple intervention, disease management program.
boolean
C0496675 (UMLS CUI [1,1])
C1561643 (UMLS CUI [1,2])
C0496675 (UMLS CUI [2,1])
C0007222 (UMLS CUI [2,2])
C0184661 (UMLS CUI [3,1])
C0439064 (UMLS CUI [3,2])
C1303150 (UMLS CUI [4])
Study Subject Participation Status | Enrollment Interventional Study
Item
currently enrolled in another interventional trial
boolean
C2348568 (UMLS CUI [1])
C1516879 (UMLS CUI [2,1])
C3274035 (UMLS CUI [2,2])
Living place Amenable Clinical Study Follow-up
Item
residing in a location not amenable to follow up for the trial
boolean
C0337646 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
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