ID

4885

Description

ODM derived from http://clinicaltrials.gov/show/NCT00296309

Link

http://clinicaltrials.gov/show/NCT00296309

Keywords

Versions (2)
  1. 3/6/12 3/6/12 -
  2. 4/13/14 4/13/14 - Julian Varghese
Uploaded on

April 13, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00296309 Kidney Transplantation

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Age 60 Years and older
Description

Age

Data type

boolean

Patients with end stage kidney disease who are suitable candidates for primary renal transplantation or retransplantation are eligible for the study. Patients receiving a kidney transplant, from a cadaveric or living donor (not HLA identical) with compatible ABO blood type can be included.
Description

Patients with end stage kidney disease. Patients receiving a kidney transplant with compatible ABO blood type.

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Patient has an immunological high risk
Description

immunological high risk

Data type

boolean

Cold ischemia time greater than 30 hours
Description

Cold ischemia time >30 hours

Data type

boolean

Patient has significant liver disease
Description

significant liver disease

Data type

boolean

Patient is allergic or intolerant to study medication
Description

allergy or intolerance to study medication

Data type

boolean

Patient or donor is known to be HIV positive.
Description

Patient or donor is HIV positive

Data type

boolean

Patient with malignancy or history of malignancy
Description

malignancy or history of malignancy

Data type

boolean

Patient has significant, uncontrolled concomitant infections
Description

significant, un-controlled concomitant infections

Data type

boolean

Medical Concepts
Description

Medical Concepts

Age
Description

Age

Data type

integer

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
397669002
disorder
Description

Disease

Data type

string

Alias
UMLS CUI
C0012634
SNOMED CT 2010_0731
64572001
Renal Disease, End-Stage
Description

End stage kidney disease

Data type

string

Alias
UMLS CUI
C1261469
SNOMED CT 2010_0731
46177005
ICD-9-CM Version 2011
585.6
Renal transplant
Description

Kidney Transplantation

Data type

string

Alias
UMLS CUI
C0022671
SNOMED CT 2010_0731
70536003
MedDRA 13.1
10038533
ICD-9-CM Version 2011
55.6
retransplantation
Description

retransplantation

Data type

string

Alias
UMLS CUI
C0597409
Structure of transplanted kidney
Description

Transplanted kidney

Data type

string

Alias
UMLS CUI
C1261317
SNOMED CT 2010_0731
70948008
LOINC Version 232
MTHU017667
Live donor
Description

Living Donors

Data type

string

Alias
UMLS CUI
C0348050
SNOMED CT 2010_0731
105456007
Donor person
Description

Donor

Data type

string

Alias
UMLS CUI
C0013018
Human leukocyte antigen
Description

HLA Antigens

Data type

string

Alias
UMLS CUI
C0019721
SNOMED CT 2010_0731
47038001
LOINC Version 232
MTHU018438
ABO blood group antigen system
Description

ABO blood group system

Data type

string

Alias
UMLS CUI
C0000778
SNOMED CT 2010_0731
63915006
LOINC Version 232
MTHU004899
Immunological Risk Factors
Description

Immunological Risk Factors

Data type

string

Alias
UMLS CUI
CL365957
Cold Ischemic Time
Description

Cold Ischemia Time

Data type

string

Alias
UMLS CUI
C1563922
LOINC Version 232
MTHU020173
Liver diseases
Description

Liver disorder

Data type

string

Alias
UMLS CUI
C0023895
SNOMED CT 2010_0731
235856003
MedDRA 13.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
Drug intolerance
Description

Drug intolerance

Data type

string

Alias
UMLS CUI
C0277585
SNOMED CT 2010_0731
59037007
MedDRA 13.1
10061822
HL7 V3 02-34
DINT
HIV Seropositivity
Description

HIV positive

Data type

string

Alias
UMLS CUI
C0019699
SNOMED CT 2010_0731
165816005
MedDRA 13.1
10020188
ICD-10-CM Version 2010
Z21
Malignant Neoplasms
Description

Cancer

Data type

string

Alias
UMLS CUI
C0006826
SNOMED CT 2010_0731
363346000
MedDRA 13.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
Infection
Description

Infection

Data type

string

Alias
UMLS CUI
C0009450
SNOMED CT 2010_0731
257551009
MedDRA 13.1
10021789
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Age
Item
Age 60 Years and older
boolean
Patients with end stage kidney disease. Patients receiving a kidney transplant with compatible ABO blood type.
Item
Patients with end stage kidney disease who are suitable candidates for primary renal transplantation or retransplantation are eligible for the study. Patients receiving a kidney transplant, from a cadaveric or living donor (not HLA identical) with compatible ABO blood type can be included.
boolean
Item Group
Exclusion Criteria
immunological high risk
Item
Patient has an immunological high risk
boolean
Cold ischemia time >30 hours
Item
Cold ischemia time greater than 30 hours
boolean
significant liver disease
Item
Patient has significant liver disease
boolean
allergy or intolerance to study medication
Item
Patient is allergic or intolerant to study medication
boolean
Patient or donor is HIV positive
Item
Patient or donor is known to be HIV positive.
boolean
malignancy or history of malignancy
Item
Patient with malignancy or history of malignancy
boolean
significant, un-controlled concomitant infections
Item
Patient has significant, uncontrolled concomitant infections
boolean
Item Group
Medical Concepts
Age
Item
Age
integer
C0001779 (UMLS CUI)
397669002 (SNOMED CT 2010_0731)
Disease
Item
disorder
string
C0012634 (UMLS CUI)
64572001 (SNOMED CT 2010_0731)
End stage kidney disease
Item
Renal Disease, End-Stage
string
C1261469 (UMLS CUI)
46177005 (SNOMED CT 2010_0731)
585.6 (ICD-9-CM Version 2011)
Kidney Transplantation
Item
Renal transplant
string
C0022671 (UMLS CUI)
70536003 (SNOMED CT 2010_0731)
10038533 (MedDRA 13.1)
55.6 (ICD-9-CM Version 2011)
retransplantation
Item
retransplantation
string
C0597409 (UMLS CUI)
Transplanted kidney
Item
Structure of transplanted kidney
string
C1261317 (UMLS CUI)
70948008 (SNOMED CT 2010_0731)
MTHU017667 (LOINC Version 232)
Living Donors
Item
Live donor
string
C0348050 (UMLS CUI)
105456007 (SNOMED CT 2010_0731)
Donor
Item
Donor person
string
C0013018 (UMLS CUI)
HLA Antigens
Item
Human leukocyte antigen
string
C0019721 (UMLS CUI)
47038001 (SNOMED CT 2010_0731)
MTHU018438 (LOINC Version 232)
ABO blood group system
Item
ABO blood group antigen system
string
C0000778 (UMLS CUI)
63915006 (SNOMED CT 2010_0731)
MTHU004899 (LOINC Version 232)
Immunological Risk Factors
Item
Immunological Risk Factors
string
CL365957 (UMLS CUI)
Cold Ischemia Time
Item
Cold Ischemic Time
string
C1563922 (UMLS CUI)
MTHU020173 (LOINC Version 232)
Liver disorder
Item
Liver diseases
string
C0023895 (UMLS CUI)
235856003 (SNOMED CT 2010_0731)
10024670 (MedDRA 13.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
Drug intolerance
Item
Drug intolerance
string
C0277585 (UMLS CUI)
59037007 (SNOMED CT 2010_0731)
10061822 (MedDRA 13.1)
DINT (HL7 V3 02-34)
HIV positive
Item
HIV Seropositivity
string
C0019699 (UMLS CUI)
165816005 (SNOMED CT 2010_0731)
10020188 (MedDRA 13.1)
Z21 (ICD-10-CM Version 2010)
Cancer
Item
Malignant Neoplasms
string
C0006826 (UMLS CUI)
363346000 (SNOMED CT 2010_0731)
10028997 (MedDRA 13.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
Infection
Item
Infection
string
C0009450 (UMLS CUI)
257551009 (SNOMED CT 2010_0731)
10021789 (MedDRA 13.1)
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