ID

20788

Beschrijving

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

Trefwoorden

  1. 17-03-17 17-03-17 -
Geüploaded op

17 maart 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility End Stage Renal Disease NCT00381602

Eligibility End Stage Renal Disease NCT00381602

Inclusion Criteria
Beschrijving

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%.
Beschrijving

Kidney Failure, Chronic | Hemodialysis | Urea reduction ratio

Datatype

boolean

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

Age

Datatype

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).
Beschrijving

Body mass index | Albumin measurement | Malnutrition Inflammation Score

Datatype

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
Beschrijving

Exclusion Criteria

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

Diabetes Mellitus | Insulin

Datatype

boolean

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

CNS disorder

Datatype

boolean

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

Communicable Disease

Datatype

boolean

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

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

Datatype

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.
Beschrijving

HYPERPARATHYROID TERTIARY Uncontrolled

Datatype

boolean

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

Anemia

Datatype

boolean

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

Hepatitis | Liver disease

Datatype

boolean

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

Similar models

Eligibility End Stage Renal Disease NCT00381602

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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