ID

31806

Description

A Study of the Pharmacokinetics of Albiglutide in Normal and Renally Impaired Subjects.; ODM derived from: https://clinicaltrials.gov/show/NCT00938158

Link

https://clinicaltrials.gov/show/NCT00938158

Keywords

Versions (1)
  1. 9/29/18 9/29/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 29, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Renal Impairment NCT00938158

English

Eligibility Renal Impairment NCT00938158

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
normal renal function or renal impairment
Description

Renal function | Renal Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C1565489
stable hemodialysis treatment for at least 3 months before screening and able to tolerate a hemodialysis treatment lasting 3-4 hours with blood flow rates of >200ml/min (cohort 3 only)
Description

Hemodialysis Stable | Hemodialysis Hour Quantity Blood Flow Rate

Data type

boolean

Alias
UMLS CUI [1,1]
C0019004
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0019004
UMLS CUI [2,2]
C0439227
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C1999075
neither pregnant nor lactating
Description

Pregnancy Absent | Breast Feeding Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
hba1c 6-10.5% inclusive
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
females of childbearing potential must be practicing adequate contraception.
Description

Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
inability to meet the pk objectives of the study
Description

PK Objectives Fulfill Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0031327
UMLS CUI [1,2]
C0018017
UMLS CUI [1,3]
C1550543
UMLS CUI [1,4]
C1299582
history of hypoglycemia unawareness or severe hypoglycemia
Description

Loss of hypoglycemic warning | Hypoglycemia Severe

Data type

boolean

Alias
UMLS CUI [1]
C0342317
UMLS CUI [2,1]
C0020615
UMLS CUI [2,2]
C0205082
liver function tests greater than or equal to 2 times the uln
Description

Increased liver function tests

Data type

boolean

Alias
UMLS CUI [1]
C0877359
clinically significant cardiovascular and/or cerebrovascular disease
Description

Cardiovascular Diseases | Cerebrovascular Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0007820
positive test results for hepatitis b, hepatitis c, or hiv
Description

Hepatitis B positive | Hepatitis C positive | HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0856706
UMLS CUI [2]
C1112419
UMLS CUI [3]
C0019699
documented hypertension or hypotension at screening
Description

Hypertensive disease | Hypotension

Data type

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0020649
known hepatic or biliary abnormalities
Description

Abnormality of the liver | Biliary tract abnormality

Data type

boolean

Alias
UMLS CUI [1]
C4021780
UMLS CUI [2]
C0549613
current use of sulfonylureas
Description

Sulfonylureas

Data type

boolean

Alias
UMLS CUI [1]
C0038766
active history of tobacco use within 6 months before screening
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
donation of blood in excess of 500ml within 56 days before albiglutide dosing
Description

Blood Donation Excess | Status pre- Albiglutide Dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C1979886
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C2607479
UMLS CUI [2,3]
C0178602
receipt of any investigational drug within the 30days or 5 half lives, whichever is longer, before dosing
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
previous or current receipt of exenatide or any other glp-1 agonist
Description

Exenatide | GLP-1 Receptor Agonist

Data type

boolean

Alias
UMLS CUI [1]
C0167117
UMLS CUI [2]
C2917359
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Similar models

Eligibility Renal Impairment NCT00938158

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Renal function | Renal Insufficiency
Item
normal renal function or renal impairment
boolean
C0232804 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
Hemodialysis Stable | Hemodialysis Hour Quantity Blood Flow Rate
Item
stable hemodialysis treatment for at least 3 months before screening and able to tolerate a hemodialysis treatment lasting 3-4 hours with blood flow rates of >200ml/min (cohort 3 only)
boolean
C0019004 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0019004 (UMLS CUI [2,1])
C0439227 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1999075 (UMLS CUI [2,4])
Pregnancy Absent | Breast Feeding Absent
Item
neither pregnant nor lactating
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Hemoglobin A1c measurement
Item
hba1c 6-10.5% inclusive
boolean
C0474680 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
females of childbearing potential must be practicing adequate contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
PK Objectives Fulfill Unable
Item
inability to meet the pk objectives of the study
boolean
C0031327 (UMLS CUI [1,1])
C0018017 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
Loss of hypoglycemic warning | Hypoglycemia Severe
Item
history of hypoglycemia unawareness or severe hypoglycemia
boolean
C0342317 (UMLS CUI [1])
C0020615 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Increased liver function tests
Item
liver function tests greater than or equal to 2 times the uln
boolean
C0877359 (UMLS CUI [1])
Cardiovascular Diseases | Cerebrovascular Disorders
Item
clinically significant cardiovascular and/or cerebrovascular disease
boolean
C0007222 (UMLS CUI [1])
C0007820 (UMLS CUI [2])
Hepatitis B positive | Hepatitis C positive | HIV Seropositivity
Item
positive test results for hepatitis b, hepatitis c, or hiv
boolean
C0856706 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Hypertensive disease | Hypotension
Item
documented hypertension or hypotension at screening
boolean
C0020538 (UMLS CUI [1])
C0020649 (UMLS CUI [2])
Abnormality of the liver | Biliary tract abnormality
Item
known hepatic or biliary abnormalities
boolean
C4021780 (UMLS CUI [1])
C0549613 (UMLS CUI [2])
Sulfonylureas
Item
current use of sulfonylureas
boolean
C0038766 (UMLS CUI [1])
Tobacco use
Item
active history of tobacco use within 6 months before screening
boolean
C0543414 (UMLS CUI [1])
Blood Donation Excess | Status pre- Albiglutide Dose
Item
donation of blood in excess of 500ml within 56 days before albiglutide dosing
boolean
C0005794 (UMLS CUI [1,1])
C1979886 (UMLS CUI [1,2])
C0332152 (UMLS CUI [2,1])
C2607479 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
Investigational New Drugs
Item
receipt of any investigational drug within the 30days or 5 half lives, whichever is longer, before dosing
boolean
C0013230 (UMLS CUI [1])
Exenatide | GLP-1 Receptor Agonist
Item
previous or current receipt of exenatide or any other glp-1 agonist
boolean
C0167117 (UMLS CUI [1])
C2917359 (UMLS CUI [2])
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