ID

39019

Description

Safety and Efficacy of Mesenchymal Precursor Cells in Diabetic Nephropathy; ODM derived from: https://clinicaltrials.gov/show/NCT01843387

Link

https://clinicaltrials.gov/show/NCT01843387

Keywords

Versions (1)
  1. 11/21/19 11/21/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 21, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetic Nephropathy NCT01843387

English

Eligibility Diabetic Nephropathy NCT01843387

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women who are ≥ 50 and ≤ 85 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subjects diagnosed with type 2 diabetes at least 2 years prior to screening
Description

Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
subjects with diabetic nephropathy and ckd stage 3b-4
Description

Diabetic Nephropathy | Chronic kidney disease stage

Data type

boolean

Alias
UMLS CUI [1]
C0011881
UMLS CUI [2]
C2074731
albumin-to-creatinine ratio (acr) from a spot urine sample >30 and < 3000 mg/g at screening
Description

Urine albumin/creatinine ratio measurement Spot urine sample

Data type

boolean

Alias
UMLS CUI [1,1]
C0455271
UMLS CUI [1,2]
C0457208
subjects must be receiving standard of care treatment for their diabetic nephropathy with an angiotensin converting enzyme inhibitor (acei) and/or an angiotensin ii receptor blocker (arb) for at least 12 weeks prior to screening.
Description

Standard of Care Diabetic Nephropathy | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist

Data type

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C0011881
UMLS CUI [2]
C0003015
UMLS CUI [3]
C0521942
hba1c < 10.0% at screening
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior participation in any stem cell study
Description

Study Subject Participation Status | Stem cell Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0038250
UMLS CUI [2,2]
C0008976
women of childbearing potential
Description

Childbearing Potential

Data type

boolean

Alias
UMLS CUI [1]
C3831118
potentially unreliable subjects and those judged by the investigator to be unsuitable for the study
Description

Study Subject Participation Status Unreliable | Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C4061925
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C1548788
history of active substance abuse (including alcohol) within the past 2 years. current alcohol abuse is defined as daily consumption of >3 alcoholic beverages (i.e. > 21 alcoholic beverages per week)
Description

Substance Use Disorders | Consumption Alcoholic Beverages U/day | Consumption Alcoholic Beverages U/week

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0001967
UMLS CUI [2,3]
C0456683
UMLS CUI [3,1]
C0001948
UMLS CUI [3,2]
C0001967
UMLS CUI [3,3]
C0560588
body weight >150 kg
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
subjects with non-diabetic renal disease e.g. known polycystic kidney disease
Description

Kidney Disease | Diabetes Mellitus Absent | Polycystic Kidney Disease

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0022680
subjects with a history of a renal transplant or who have had prior dialysis within 3 months of screening and/or have not maintained a stable level of kidney function within 3 months of screening
Description

Kidney Transplantation | Dialysis | Renal function Stable Lacking

Data type

boolean

Alias
UMLS CUI [1]
C0022671
UMLS CUI [2]
C0011946
UMLS CUI [3,1]
C0232804
UMLS CUI [3,2]
C0205360
UMLS CUI [3,3]
C0332268
current or history within 6 months of screening of nyha class iii or iv heart failure
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
myocardial infarction or stroke within 6 months prior to screening
Description

Myocardial Infarction | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
any concurrent medical condition/disorder or clinically symptomatic cardiovascular, gastrointestinal, hematological, pulmonary, acute or chronic infectious disease, active retinal disease or other disorder which in the investigator's opinion would interfere with the subjects ability to complete the trial, would require administration of treatment that could affect the interpretation of the efficacy and safety variables or would preclude safe involvement in the study
Description

Comorbidity Interferes with Completion of clinical trial | Cardiovascular Disease Symptomatic | Gastrointestinal Diseases | Hematological Disease | Lung diseases | Communicable Disease | Chronic infectious disease | Retinal Diseases | Therapy Affecting Evaluation | Therapy Study Subject Participation Status Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2732579
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0231220
UMLS CUI [3]
C0017178
UMLS CUI [4]
C0018939
UMLS CUI [5]
C0024115
UMLS CUI [6]
C0009450
UMLS CUI [7]
C0151317
UMLS CUI [8]
C0035309
UMLS CUI [9,1]
C0087111
UMLS CUI [9,2]
C0392760
UMLS CUI [9,3]
C1261322
UMLS CUI [10,1]
C0087111
UMLS CUI [10,2]
C2348568
UMLS CUI [10,3]
C0332196
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Similar models

Eligibility Diabetic Nephropathy NCT01843387

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men and women who are ≥ 50 and ≤ 85 years old
boolean
C0001779 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
subjects diagnosed with type 2 diabetes at least 2 years prior to screening
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Diabetic Nephropathy | Chronic kidney disease stage
Item
subjects with diabetic nephropathy and ckd stage 3b-4
boolean
C0011881 (UMLS CUI [1])
C2074731 (UMLS CUI [2])
Urine albumin/creatinine ratio measurement Spot urine sample
Item
albumin-to-creatinine ratio (acr) from a spot urine sample >30 and < 3000 mg/g at screening
boolean
C0455271 (UMLS CUI [1,1])
C0457208 (UMLS CUI [1,2])
Standard of Care Diabetic Nephropathy | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist
Item
subjects must be receiving standard of care treatment for their diabetic nephropathy with an angiotensin converting enzyme inhibitor (acei) and/or an angiotensin ii receptor blocker (arb) for at least 12 weeks prior to screening.
boolean
C2936643 (UMLS CUI [1,1])
C0011881 (UMLS CUI [1,2])
C0003015 (UMLS CUI [2])
C0521942 (UMLS CUI [3])
Hemoglobin A1c measurement
Item
hba1c < 10.0% at screening
boolean
C0474680 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Stem cell Clinical Trial
Item
prior participation in any stem cell study
boolean
C2348568 (UMLS CUI [1])
C0038250 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
Childbearing Potential
Item
women of childbearing potential
boolean
C3831118 (UMLS CUI [1])
Study Subject Participation Status Unreliable | Study Subject Participation Status Inappropriate
Item
potentially unreliable subjects and those judged by the investigator to be unsuitable for the study
boolean
C2348568 (UMLS CUI [1,1])
C4061925 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
Substance Use Disorders | Consumption Alcoholic Beverages U/day | Consumption Alcoholic Beverages U/week
Item
history of active substance abuse (including alcohol) within the past 2 years. current alcohol abuse is defined as daily consumption of >3 alcoholic beverages (i.e. > 21 alcoholic beverages per week)
boolean
C0038586 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0001967 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0001948 (UMLS CUI [3,1])
C0001967 (UMLS CUI [3,2])
C0560588 (UMLS CUI [3,3])
Body Weight
Item
body weight >150 kg
boolean
C0005910 (UMLS CUI [1])
Kidney Disease | Diabetes Mellitus Absent | Polycystic Kidney Disease
Item
subjects with non-diabetic renal disease e.g. known polycystic kidney disease
boolean
C0022658 (UMLS CUI [1])
C0011849 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0022680 (UMLS CUI [3])
Kidney Transplantation | Dialysis | Renal function Stable Lacking
Item
subjects with a history of a renal transplant or who have had prior dialysis within 3 months of screening and/or have not maintained a stable level of kidney function within 3 months of screening
boolean
C0022671 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
C0232804 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
Heart failure New York Heart Association Classification
Item
current or history within 6 months of screening of nyha class iii or iv heart failure
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Myocardial Infarction | Cerebrovascular accident
Item
myocardial infarction or stroke within 6 months prior to screening
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Comorbidity Interferes with Completion of clinical trial | Cardiovascular Disease Symptomatic | Gastrointestinal Diseases | Hematological Disease | Lung diseases | Communicable Disease | Chronic infectious disease | Retinal Diseases | Therapy Affecting Evaluation | Therapy Study Subject Participation Status Excluded
Item
any concurrent medical condition/disorder or clinically symptomatic cardiovascular, gastrointestinal, hematological, pulmonary, acute or chronic infectious disease, active retinal disease or other disorder which in the investigator's opinion would interfere with the subjects ability to complete the trial, would require administration of treatment that could affect the interpretation of the efficacy and safety variables or would preclude safe involvement in the study
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0007222 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0017178 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
C0024115 (UMLS CUI [5])
C0009450 (UMLS CUI [6])
C0151317 (UMLS CUI [7])
C0035309 (UMLS CUI [8])
C0087111 (UMLS CUI [9,1])
C0392760 (UMLS CUI [9,2])
C1261322 (UMLS CUI [9,3])
C0087111 (UMLS CUI [10,1])
C2348568 (UMLS CUI [10,2])
C0332196 (UMLS CUI [10,3])
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