ID

23796

Descrição

A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease Including Assessment of Quality of Life (EPPIC-2); ODM derived from: https://clinicaltrials.gov/show/NCT00501046

Link

https://clinicaltrials.gov/show/NCT00501046

Palavras-chave

Versões (1)
  1. 13/07/2017 13/07/2017 -
Transferido a

13 de julho de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Chronic Kidney Disease NCT00501046

Inglês

Eligibility Chronic Kidney Disease NCT00501046

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18 years or older
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
moderate to severe ckd, not anticipated to require dialysis or renal transplant within the next 6 months
Descrição

Chronic Kidney Disease Moderate | Chronic Kidney Disease Severe | Dialysis Unexpected | Kidney Transplantation Unexpected

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1561643
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C1561643
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0011946
UMLS CUI [3,2]
C4055646
UMLS CUI [4,1]
C0022671
UMLS CUI [4,2]
C4055646
patient survival expected to be no less than one year
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
serum creatinine in men >= 2.0 mg/dl (>= 177 µmol/l) and <= 5.0 mg/dl (<= 442
Descrição

Creatinine measurement, serum | Gender

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0079399
µmol/l), and in women >= 1.5 mg/dl (>= 133 µmol/l) and <= 5.0 mg/dl (<= 442 µmol/l) at screening
Descrição

Creatinine measurement, serum | Gender | Screening

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0220908
urinary total protein to urinary total creatinine ratio must be >= 0.5 on a spot void obtained at screening
Descrição

Urine protein/creatinine ratio measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1096054
blood pressure <= 160/90 mmhg at both screening and baseline visits. in addition, blood pressure, if measured, must have been stable in hypertensive patients over the 3 months prior to screening, with no more than 1 blood pressure reading > 160/90 mmhg
Descrição

Blood pressure | Patient Hypertensive Stable blood pressure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1271104
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0857121
UMLS CUI [2,3]
C0428896
in patients being treated for hypertension, they should be on a stable anti-hypertensive regimen
Descrição

Therapeutic procedure Hypertensive disease | Antihypertensive therapy Stable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0020538
UMLS CUI [2,1]
C0585941
UMLS CUI [2,2]
C0205360
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
obstructive or reversible cause of kidney disease
Descrição

Kidney Disease Obstructive | Kidney Disease Cause Reversible

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0549186
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0205343
nephrotic syndrome defined as a ratio of urinary total protein to urinary creatinine of > 6.0 as measured on a spot void
Descrição

Nephrotic Syndrome | Urine protein/creatinine ratio measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027726
UMLS CUI [2]
C1096054
adult polycystic kidney disease
Descrição

Polycystic Kidney Disease Adult

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0022680
UMLS CUI [1,2]
C0001675
history of previous kidney transplant
Descrição

Kidney Transplantation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022671
history of recent (within the past 6 months) accelerated or malignant hypertension
Descrição

Malignant Hypertension

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020540
uncontrolled arrhythmia or severe cardiac disease within the past 6 months
Descrição

Cardiac Arrhythmia Uncontrolled | Heart Disease Severe

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0205082
history of malabsorption, inflammatory bowel disease, hiatal hernia, active peptic ulcer, or severe gi dysmotility, not attributable to the use of a phosphate binder
Descrição

Malabsorption | Inflammatory Bowel Diseases | Hiatal Hernia | Peptic Ulcer | Gastrointestinal dysmotility Severe | Phosphate Binder Etiology aspects Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3714745
UMLS CUI [2]
C0021390
UMLS CUI [3]
C3489393
UMLS CUI [4]
C0030920
UMLS CUI [5,1]
C1836923
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C2267031
UMLS CUI [6,2]
C0015127
UMLS CUI [6,3]
C0332197
received any investigational agent or participated in a clinical study within the previous 3 months
Descrição

Investigational New Drugs | Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2348568
presence of any significant medical condition that might create an undue risk with study participation, or significantly confound the collection of safety and efficacy data in this study
Descrição

Medical condition At risk Study Subject Participation Status | Medical condition Interferes with Safety Study data | Medical condition Interferes with Effectiveness Study data

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0036043
UMLS CUI [2,4]
C0681873
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C1280519
UMLS CUI [3,4]
C0681873
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Similar models

Eligibility Chronic Kidney Disease NCT00501046

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18 years or older
boolean
C0001779 (UMLS CUI [1])
Chronic Kidney Disease Moderate | Chronic Kidney Disease Severe | Dialysis Unexpected | Kidney Transplantation Unexpected
Item
moderate to severe ckd, not anticipated to require dialysis or renal transplant within the next 6 months
boolean
C1561643 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C1561643 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0011946 (UMLS CUI [3,1])
C4055646 (UMLS CUI [3,2])
C0022671 (UMLS CUI [4,1])
C4055646 (UMLS CUI [4,2])
Life Expectancy
Item
patient survival expected to be no less than one year
boolean
C0023671 (UMLS CUI [1])
Creatinine measurement, serum | Gender
Item
serum creatinine in men >= 2.0 mg/dl (>= 177 µmol/l) and <= 5.0 mg/dl (<= 442
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Creatinine measurement, serum | Gender | Screening
Item
µmol/l), and in women >= 1.5 mg/dl (>= 133 µmol/l) and <= 5.0 mg/dl (<= 442 µmol/l) at screening
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0220908 (UMLS CUI [3])
Urine protein/creatinine ratio measurement
Item
urinary total protein to urinary total creatinine ratio must be >= 0.5 on a spot void obtained at screening
boolean
C1096054 (UMLS CUI [1])
Blood pressure | Patient Hypertensive Stable blood pressure
Item
blood pressure <= 160/90 mmhg at both screening and baseline visits. in addition, blood pressure, if measured, must have been stable in hypertensive patients over the 3 months prior to screening, with no more than 1 blood pressure reading > 160/90 mmhg
boolean
C1271104 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0857121 (UMLS CUI [2,2])
C0428896 (UMLS CUI [2,3])
Therapeutic procedure Hypertensive disease | Antihypertensive therapy Stable
Item
in patients being treated for hypertension, they should be on a stable anti-hypertensive regimen
boolean
C0087111 (UMLS CUI [1,1])
C0020538 (UMLS CUI [1,2])
C0585941 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Kidney Disease Obstructive | Kidney Disease Cause Reversible
Item
obstructive or reversible cause of kidney disease
boolean
C0022658 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0205343 (UMLS CUI [2,3])
Nephrotic Syndrome | Urine protein/creatinine ratio measurement
Item
nephrotic syndrome defined as a ratio of urinary total protein to urinary creatinine of > 6.0 as measured on a spot void
boolean
C0027726 (UMLS CUI [1])
C1096054 (UMLS CUI [2])
Polycystic Kidney Disease Adult
Item
adult polycystic kidney disease
boolean
C0022680 (UMLS CUI [1,1])
C0001675 (UMLS CUI [1,2])
Kidney Transplantation
Item
history of previous kidney transplant
boolean
C0022671 (UMLS CUI [1])
Malignant Hypertension
Item
history of recent (within the past 6 months) accelerated or malignant hypertension
boolean
C0020540 (UMLS CUI [1])
Cardiac Arrhythmia Uncontrolled | Heart Disease Severe
Item
uncontrolled arrhythmia or severe cardiac disease within the past 6 months
boolean
C0003811 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Malabsorption | Inflammatory Bowel Diseases | Hiatal Hernia | Peptic Ulcer | Gastrointestinal dysmotility Severe | Phosphate Binder Etiology aspects Absent
Item
history of malabsorption, inflammatory bowel disease, hiatal hernia, active peptic ulcer, or severe gi dysmotility, not attributable to the use of a phosphate binder
boolean
C3714745 (UMLS CUI [1])
C0021390 (UMLS CUI [2])
C3489393 (UMLS CUI [3])
C0030920 (UMLS CUI [4])
C1836923 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C2267031 (UMLS CUI [6,1])
C0015127 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
Investigational New Drugs | Study Subject Participation Status
Item
received any investigational agent or participated in a clinical study within the previous 3 months
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Medical condition At risk Study Subject Participation Status | Medical condition Interferes with Safety Study data | Medical condition Interferes with Effectiveness Study data
Item
presence of any significant medical condition that might create an undue risk with study participation, or significantly confound the collection of safety and efficacy data in this study
boolean
C3843040 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0036043 (UMLS CUI [2,3])
C0681873 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1280519 (UMLS CUI [3,3])
C0681873 (UMLS CUI [3,4])
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