ID

20788

Description

A Phase II, Randomized, Cross-Over, Vehicle-Controlled, Double-Blind, Multicenter Study of the Safety, Pharmacodynamics, and Preliminary Efficacy of GHRP-1/AG in Subjects With ESRD on Hemodialysis; ODM derived from: https://clinicaltrials.gov/show/NCT00381602

Link

https://clinicaltrials.gov/show/NCT00381602

Keywords

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

March 17, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility End Stage Renal Disease NCT00381602

English

Eligibility End Stage Renal Disease NCT00381602

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with esrd who have been on hd for at least 3 months and have a urea reduction rate (urr) of at least 65%.
Description

Kidney Failure, Chronic | Hemodialysis | Urea reduction ratio

Data type

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C0019004
UMLS CUI [3]
C2718317
subjects who are 18 to 70 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subjects who have a body mass index (bmi) less than 30, albumin greater than 3.3 g/dl, and mis of 5 to 10 (inclusive).
Description

Body mass index | Albumin measurement | Malnutrition Inflammation Score

Data type

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0201838
UMLS CUI [3,1]
C0162429
UMLS CUI [3,2]
C0021368
UMLS CUI [3,3]
C0449820
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who have diabetes and are currently taking insulin.
Description

Diabetes Mellitus | Insulin

Data type

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0021641
subjects who have a history of or current significant central nervous system (cns) disorders.
Description

CNS disorder

Data type

boolean

Alias
UMLS CUI [1]
C0007682
subjects who have active infection at baseline.
Description

Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450
subjects who have active or unstable cardiac or arterial disease.
Description

Heart Disease | Heart Disease Unstable | Arteriopathic disease | Arteriopathic disease Unstable

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0443343
UMLS CUI [3]
C0852949
UMLS CUI [4,1]
C0852949
UMLS CUI [4,2]
C0443343
subjects who have uncontrolled tertiary hyperparathyroid condition.
Description

HYPERPARATHYROID TERTIARY Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0745108
UMLS CUI [1,2]
C0205318
subjects who have anemia.
Description

Anemia

Data type

boolean

Alias
UMLS CUI [1]
C0002871
subjects who have a history of hepatitis or current liver disease.
Description

Hepatitis | Liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0019158
UMLS CUI [2]
C0023895
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Similar models

Eligibility End Stage Renal Disease NCT00381602

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Kidney Failure, Chronic | Hemodialysis | Urea reduction ratio
Item
subjects with esrd who have been on hd for at least 3 months and have a urea reduction rate (urr) of at least 65%.
boolean
C0022661 (UMLS CUI [1])
C0019004 (UMLS CUI [2])
C2718317 (UMLS CUI [3])
Age
Item
subjects who are 18 to 70 years of age.
boolean
C0001779 (UMLS CUI [1])
Body mass index | Albumin measurement | Malnutrition Inflammation Score
Item
subjects who have a body mass index (bmi) less than 30, albumin greater than 3.3 g/dl, and mis of 5 to 10 (inclusive).
boolean
C1305855 (UMLS CUI [1])
C0201838 (UMLS CUI [2])
C0162429 (UMLS CUI [3,1])
C0021368 (UMLS CUI [3,2])
C0449820 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus | Insulin
Item
subjects who have diabetes and are currently taking insulin.
boolean
C0011849 (UMLS CUI [1])
C0021641 (UMLS CUI [2])
CNS disorder
Item
subjects who have a history of or current significant central nervous system (cns) disorders.
boolean
C0007682 (UMLS CUI [1])
Communicable Disease
Item
subjects who have active infection at baseline.
boolean
C0009450 (UMLS CUI [1])
Heart Disease | Heart Disease Unstable | Arteriopathic disease | Arteriopathic disease Unstable
Item
subjects who have active or unstable cardiac or arterial disease.
boolean
C0018799 (UMLS CUI [1])
C0018799 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0852949 (UMLS CUI [3])
C0852949 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
HYPERPARATHYROID TERTIARY Uncontrolled
Item
subjects who have uncontrolled tertiary hyperparathyroid condition.
boolean
C0745108 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Anemia
Item
subjects who have anemia.
boolean
C0002871 (UMLS CUI [1])
Hepatitis | Liver disease
Item
subjects who have a history of hepatitis or current liver disease.
boolean
C0019158 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
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