ID

14250

Description

ALLOGRAFT, A Study to Evaluate the Renal Protective Effects of Losartan (0954-222)(COMPLETED); ODM derived from: https://clinicaltrials.gov/show/NCT00140907

Link

https://clinicaltrials.gov/show/NCT00140907

Keywords

Versions (2)
  1. 4/4/16 4/4/16 -
  2. 4/5/16 4/5/16 - Julian Varghese
Uploaded on

April 5, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility High Blood Pressure NCT00140907

English

Eligibility High Blood Pressure NCT00140907

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with end stage chronic renal failure, four to eight week after receiving a first or a second renal transplant from a dead donor. in the case of a second transplant the survival of the first graft must has been 6 month or more
Description

Renal failure: renal transplant from a dead donor

Data type

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C0973442
UMLS CUI [3]
C0022671
patients must have a serum creatinine * 2 at visit 1 and 2. results must be within 25% of each other. the baseline period may be extended until four more weeks to obtain an additional serum creatinine if one of the first two serum creatinine results do not qualify
Description

Serum creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
patients with hypertension must have a sitting blood pressure < 200/110 mmhg at the time of randomization
Description

Sitting blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0580946
normotensive patients must have a sitting systolic blood pressure >100 mmhg at the time of randomization
Description

Sitting systolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C1319893
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
hyperimmunized patients at the transplant time or in the previous 6 month, with a pra of 50 %
Description

Hyperimmunized patients and Panel-reactive antibody

Data type

boolean

Alias
UMLS CUI [1,1]
C0301877
UMLS CUI [1,2]
C1141951
patients with evidence of advanced liver disease
Description

Liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
serum potassium <3.5 or >5.5 meq/l
Description

Serum potassium

Data type

boolean

Alias
UMLS CUI [1]
C0202194
history of allergy to losartan
Description

Allergy to losartan

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0126174
other factors which may affect participation (e.g., significant concurrent or life limiting disease such as cancer in the last five year except skin neoplasias, mental or legal incapacitation, drug or alcohol abuse within the last 2 years, extensive travel planned in the next 3 years, investigative drug trial within the last 4 weeks)
Description

Factors affecting participation

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0679823
patients with disseminated or localized active infectious disease, at the time of transplant
Description

Disseminated or localized active infectious disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0205221
UMLS CUI [1,2]
C3262321
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C3262321
acute graft rejection in the grade iii of banff classification
Description

acute graft rejection

Data type

boolean

Alias
UMLS CUI [1]
C1736177
patients with double-transplant (reno-pancreatic)
Description

Reno-pancreatic transplant

Data type

boolean

Alias
UMLS CUI [1,1]
C0030275
UMLS CUI [1,2]
C0022671
patients with heart failure or history of myocardial infarction requiring ace inhibitor or aiia therapies. presence or known history of hemodynamically significant obstructive valvular disease or hypertrophic cardiomyopathy
Description

Cardiovascular status

Data type

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0003015
UMLS CUI [4]
C1384985
UMLS CUI [5]
C0007194
renal graft artery stenosis. an eco-doppler test must be performed in order to exclude a graft artery stenosis
Description

Eco-doppler test: renal graft artery stenosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0035067
UMLS CUI [1,2]
C0022671
UMLS CUI [1,3]
C0162481
pregnant or nursing women
Description

Gynaecological status

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
chronic use of nsaids
Description

Chronic use of nsaids

Data type

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C1398175
major psychotropic agents such as phenothiazines are not permitted, use of lithium is not permitted
Description

Phenothiazines or lithium

Data type

boolean

Alias
UMLS CUI [1]
C0031436
UMLS CUI [2]
C3540800
Back to the top of the page

Similar models

Eligibility High Blood Pressure NCT00140907

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Renal failure: renal transplant from a dead donor
Item
patients with end stage chronic renal failure, four to eight week after receiving a first or a second renal transplant from a dead donor. in the case of a second transplant the survival of the first graft must has been 6 month or more
boolean
C0022661 (UMLS CUI [1])
C0973442 (UMLS CUI [2])
C0022671 (UMLS CUI [3])
Serum creatinine
Item
patients must have a serum creatinine * 2 at visit 1 and 2. results must be within 25% of each other. the baseline period may be extended until four more weeks to obtain an additional serum creatinine if one of the first two serum creatinine results do not qualify
boolean
C0201976 (UMLS CUI [1])
Sitting blood pressure
Item
patients with hypertension must have a sitting blood pressure < 200/110 mmhg at the time of randomization
boolean
C0580946 (UMLS CUI [1])
Sitting systolic blood pressure
Item
normotensive patients must have a sitting systolic blood pressure >100 mmhg at the time of randomization
boolean
C1319893 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hyperimmunized patients and Panel-reactive antibody
Item
hyperimmunized patients at the transplant time or in the previous 6 month, with a pra of 50 %
boolean
C0301877 (UMLS CUI [1,1])
C1141951 (UMLS CUI [1,2])
Liver disease
Item
patients with evidence of advanced liver disease
boolean
C0023895 (UMLS CUI [1])
Serum potassium
Item
serum potassium <3.5 or >5.5 meq/l
boolean
C0202194 (UMLS CUI [1])
Allergy to losartan
Item
history of allergy to losartan
boolean
C0020517 (UMLS CUI [1,1])
C0126174 (UMLS CUI [1,2])
Factors affecting participation
Item
other factors which may affect participation (e.g., significant concurrent or life limiting disease such as cancer in the last five year except skin neoplasias, mental or legal incapacitation, drug or alcohol abuse within the last 2 years, extensive travel planned in the next 3 years, investigative drug trial within the last 4 weeks)
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0679823 (UMLS CUI [1,3])
Disseminated or localized active infectious disease
Item
patients with disseminated or localized active infectious disease, at the time of transplant
boolean
C0205221 (UMLS CUI [1,1])
C3262321 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C3262321 (UMLS CUI [2,2])
acute graft rejection
Item
acute graft rejection in the grade iii of banff classification
boolean
C1736177 (UMLS CUI [1])
Reno-pancreatic transplant
Item
patients with double-transplant (reno-pancreatic)
boolean
C0030275 (UMLS CUI [1,1])
C0022671 (UMLS CUI [1,2])
Cardiovascular status
Item
patients with heart failure or history of myocardial infarction requiring ace inhibitor or aiia therapies. presence or known history of hemodynamically significant obstructive valvular disease or hypertrophic cardiomyopathy
boolean
C0018801 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0003015 (UMLS CUI [3])
C1384985 (UMLS CUI [4])
C0007194 (UMLS CUI [5])
Eco-doppler test: renal graft artery stenosis
Item
renal graft artery stenosis. an eco-doppler test must be performed in order to exclude a graft artery stenosis
boolean
C0035067 (UMLS CUI [1,1])
C0022671 (UMLS CUI [1,2])
C0162481 (UMLS CUI [1,3])
Gynaecological status
Item
pregnant or nursing women
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Chronic use of nsaids
Item
chronic use of nsaids
boolean
C0003211 (UMLS CUI [1,1])
C1398175 (UMLS CUI [1,2])
Phenothiazines or lithium
Item
major psychotropic agents such as phenothiazines are not permitted, use of lithium is not permitted
boolean
C0031436 (UMLS CUI [1])
C3540800 (UMLS CUI [2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial