ID

40712

Beskrivning

A Study to Evaluate the Effect of Renal Function on the Biological Activity of Telavancin; ODM derived from: https://clinicaltrials.gov/show/NCT01238796

Länk

https://clinicaltrials.gov/show/NCT01238796

Nyckelord

Versioner (1)
  1. 2020-05-02 2020-05-02 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

2 maj 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Kidney Diseases NCT01238796

Engelsk

Eligibility Kidney Diseases NCT01238796

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
weighs at least 45 kg and body mass index of 18 to 40 kg/m2, inclusive
Beskrivning

Body Weight | Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C1305855
an estimated creatinine clearance value based on cockcroft-gault method of:
Beskrivning

Estimation of creatinine clearance by Cockcroft-Gault formula

Datatyp

boolean

Alias
UMLS CUI [1]
C2711451
>80 ml/min for subjects with normal renal function
Beskrivning

Normal renal function

Datatyp

boolean

Alias
UMLS CUI [1]
C0232805
<30 ml/min for subjects with severe renal impairment
Beskrivning

Renal Insufficiency Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
receiving hemodialysis three times a week for subjects with end stage renal impairment
Beskrivning

Hemodialysis times per week | Renal Insufficiency End-stage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019004
UMLS CUI [1,2]
C0456698
UMLS CUI [2,1]
C1565489
UMLS CUI [2,2]
C0205088
if female, the subject is at least 2 years postmenopausal, surgically sterile or practicing effective birth control, and is not pregnant or lactating
Beskrivning

Gender | Postmenopausal state | Female Sterilization | Contraceptive methods | Pregnancy Absent | Breast Feeding Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0700589
UMLS CUI [5,1]
C0032961
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0006147
UMLS CUI [6,2]
C0332197
good venous access
Beskrivning

Venous access patent

Datatyp

boolean

Alias
UMLS CUI [1]
C3164222
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of any clinically significant acute illness (other than renal disease and conditions related to the renal disease in renal impairment subjects, such as stable diabetes or hypertension)
Beskrivning

Illness Clinical Significance | Exception Kidney Disease | Exception Diabetes Mellitus Stable | Exception Hypertensive disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0022658
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0011849
UMLS CUI [3,3]
C0205360
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0020538
has had a kidney transplant that is still functioning
Beskrivning

Kidney Transplantation

Datatyp

boolean

Alias
UMLS CUI [1]
C0022671
history of unexplained syncope, cardiac arrest, unexplained cardiac arrythmia or torsade de pointes, structural heart disease, prolonged qt interval, or family history of long qt syndrome
Beskrivning

Syncope Unexplained | Cardiac Arrest | Cardiac Arrhythmia Unexplained | Torsades de Pointes | Structural disorder of heart | Prolonged QT interval | Family history of long QT syndrome

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0039070
UMLS CUI [1,2]
C4288071
UMLS CUI [2]
C0018790
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C4288071
UMLS CUI [4]
C0040479
UMLS CUI [5]
C1290384
UMLS CUI [6]
C0151878
UMLS CUI [7]
C3839836
known hypersensitivity to telavancin or any of the excipients in the formulation, or a history of severe allergic or anaphylactic reactions
Beskrivning

Hypersensitivity Telavancin | Hypersensitivity Telavancin Excipient | Allergic Reaction Severe | Anaphylaxis Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1453642
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1453642
UMLS CUI [2,3]
C0015237
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0002792
UMLS CUI [4,2]
C0205082
history of consuming more than 7 units of alcoholic beverages per week, or history of alcoholism or substance abuse within past 2 years
Beskrivning

Alcohol consumption Alcoholic Beverages U/week | Alcoholic Intoxication, Chronic | Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0001967
UMLS CUI [1,3]
C0560588
UMLS CUI [2]
C0001973
UMLS CUI [3]
C0038586
known to be positive for human immunodeficiency virus antibody
Beskrivning

HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
for subjects with normal renal function, has had treatment with prescription or non-prescription drugs, including complementary and alternative medicines or over-the counter medications, with the exception of oral contraceptives, hormone replacement therapy, daily aspirin, and occasional use of acetaminophen within the past 14 days
Beskrivning

Normal renal function | Pharmacotherapy | Prescription Drugs | Drugs, Non-Prescription | Complementary and alternative medicine | Exception Oral Contraceptives | Exception Hormone replacement therapy | Exception Aspirin Daily | Exception Acetaminophen Occasional

Datatyp

boolean

Alias
UMLS CUI [1]
C0232805
UMLS CUI [2]
C0013216
UMLS CUI [3]
C0304227
UMLS CUI [4]
C0013231
UMLS CUI [5]
C1148475
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0009905
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0282402
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0004057
UMLS CUI [8,3]
C0332173
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0000970
UMLS CUI [9,3]
C0521114
for subjects with renal impairment, has not been on a stable dose of concomitant medications for at least 2 weeks prior to study start or is taking any medication that would interfere with the evaluation of televancin in this study
Beskrivning

Renal Insufficiency | Absence Pharmaceutical Preparations Stable | Pharmaceutical Preparations Interfere Evaluation Telavancin

Datatyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C1261322
UMLS CUI [3,4]
C1453642
has received an experimental agent within 30 days or ten half-lives, whichever is longer, prior to study drug administration
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
has had any significant blood loss, donated one unit (450 ml) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to admission
Beskrivning

Blood Loss Significant | Blood Donation Amount | Blood Transfusion Received | Plasma donation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3163616
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0005794
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0005841
UMLS CUI [3,2]
C1514756
UMLS CUI [4,1]
C0032105
UMLS CUI [4,2]
C0680854
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Similar models

Eligibility Kidney Diseases NCT01238796

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Body Weight | Body mass index
Item
weighs at least 45 kg and body mass index of 18 to 40 kg/m2, inclusive
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
an estimated creatinine clearance value based on cockcroft-gault method of:
boolean
C2711451 (UMLS CUI [1])
Normal renal function
Item
>80 ml/min for subjects with normal renal function
boolean
C0232805 (UMLS CUI [1])
Renal Insufficiency Severe
Item
<30 ml/min for subjects with severe renal impairment
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Hemodialysis times per week | Renal Insufficiency End-stage
Item
receiving hemodialysis three times a week for subjects with end stage renal impairment
boolean
C0019004 (UMLS CUI [1,1])
C0456698 (UMLS CUI [1,2])
C1565489 (UMLS CUI [2,1])
C0205088 (UMLS CUI [2,2])
Gender | Postmenopausal state | Female Sterilization | Contraceptive methods | Pregnancy Absent | Breast Feeding Absent
Item
if female, the subject is at least 2 years postmenopausal, surgically sterile or practicing effective birth control, and is not pregnant or lactating
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
C0032961 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0006147 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Venous access patent
Item
good venous access
boolean
C3164222 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Illness Clinical Significance | Exception Kidney Disease | Exception Diabetes Mellitus Stable | Exception Hypertensive disease
Item
history of any clinically significant acute illness (other than renal disease and conditions related to the renal disease in renal impairment subjects, such as stable diabetes or hypertension)
boolean
C0221423 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0022658 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0011849 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0020538 (UMLS CUI [4,2])
Kidney Transplantation
Item
has had a kidney transplant that is still functioning
boolean
C0022671 (UMLS CUI [1])
Syncope Unexplained | Cardiac Arrest | Cardiac Arrhythmia Unexplained | Torsades de Pointes | Structural disorder of heart | Prolonged QT interval | Family history of long QT syndrome
Item
history of unexplained syncope, cardiac arrest, unexplained cardiac arrythmia or torsade de pointes, structural heart disease, prolonged qt interval, or family history of long qt syndrome
boolean
C0039070 (UMLS CUI [1,1])
C4288071 (UMLS CUI [1,2])
C0018790 (UMLS CUI [2])
C0003811 (UMLS CUI [3,1])
C4288071 (UMLS CUI [3,2])
C0040479 (UMLS CUI [4])
C1290384 (UMLS CUI [5])
C0151878 (UMLS CUI [6])
C3839836 (UMLS CUI [7])
Hypersensitivity Telavancin | Hypersensitivity Telavancin Excipient | Allergic Reaction Severe | Anaphylaxis Severe
Item
known hypersensitivity to telavancin or any of the excipients in the formulation, or a history of severe allergic or anaphylactic reactions
boolean
C0020517 (UMLS CUI [1,1])
C1453642 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1453642 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C1527304 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0002792 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Alcohol consumption Alcoholic Beverages U/week | Alcoholic Intoxication, Chronic | Substance Use Disorders
Item
history of consuming more than 7 units of alcoholic beverages per week, or history of alcoholism or substance abuse within past 2 years
boolean
C0001948 (UMLS CUI [1,1])
C0001967 (UMLS CUI [1,2])
C0560588 (UMLS CUI [1,3])
C0001973 (UMLS CUI [2])
C0038586 (UMLS CUI [3])
HIV Seropositivity
Item
known to be positive for human immunodeficiency virus antibody
boolean
C0019699 (UMLS CUI [1])
Normal renal function | Pharmacotherapy | Prescription Drugs | Drugs, Non-Prescription | Complementary and alternative medicine | Exception Oral Contraceptives | Exception Hormone replacement therapy | Exception Aspirin Daily | Exception Acetaminophen Occasional
Item
for subjects with normal renal function, has had treatment with prescription or non-prescription drugs, including complementary and alternative medicines or over-the counter medications, with the exception of oral contraceptives, hormone replacement therapy, daily aspirin, and occasional use of acetaminophen within the past 14 days
boolean
C0232805 (UMLS CUI [1])
C0013216 (UMLS CUI [2])
C0304227 (UMLS CUI [3])
C0013231 (UMLS CUI [4])
C1148475 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C0009905 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0282402 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0004057 (UMLS CUI [8,2])
C0332173 (UMLS CUI [8,3])
C1705847 (UMLS CUI [9,1])
C0000970 (UMLS CUI [9,2])
C0521114 (UMLS CUI [9,3])
Renal Insufficiency | Absence Pharmaceutical Preparations Stable | Pharmaceutical Preparations Interfere Evaluation Telavancin
Item
for subjects with renal impairment, has not been on a stable dose of concomitant medications for at least 2 weeks prior to study start or is taking any medication that would interfere with the evaluation of televancin in this study
boolean
C1565489 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1261322 (UMLS CUI [3,3])
C1453642 (UMLS CUI [3,4])
Investigational New Drugs
Item
has received an experimental agent within 30 days or ten half-lives, whichever is longer, prior to study drug administration
boolean
C0013230 (UMLS CUI [1])
Blood Loss Significant | Blood Donation Amount | Blood Transfusion Received | Plasma donation
Item
has had any significant blood loss, donated one unit (450 ml) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to admission
boolean
C3163616 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0005794 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0005841 (UMLS CUI [3,1])
C1514756 (UMLS CUI [3,2])
C0032105 (UMLS CUI [4,1])
C0680854 (UMLS CUI [4,2])
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