Eligibility NCT00717470 Kidney Transplantation
ODM derived from http://clinicaltrials.gov/show/NCT00717470

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 12 months)
Item
End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 12 months)
boolean
C1261469 (UMLS CUI 2011AA)
46177005 (SNOMED CT 2011_0131)
585.6 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
CL414904 (UMLS CUI 2011AA)
C0022671 (UMLS CUI 2011AA)
70536003 (SNOMED CT 2011_0131)
10038533 (MedDRA 14.1)
55.6 (ICD-9-CM Version 2011)
C0597409 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0332835 (UMLS CUI 2011AA)
24486003 (SNOMED CT 2011_0131)
C0745777 (UMLS CUI 2011AA)
C0018129 (UMLS CUI 2011AA)
72627004 (SNOMED CT 2011_0131)
10044439 (MedDRA 14.1)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
Receiving a kidney transplant from a cadaveric or living (non HLA identical) donor with compatible ABO blood type
Item
Receiving a kidney transplant from a cadaveric or living (non HLA identical) donor with compatible ABO blood type
boolean
C1514756 (UMLS CUI 2011AA)
C0022671 (UMLS CUI 2011AA)
70536003 (SNOMED CT 2011_0131)
10038533 (MedDRA 14.1)
55.6 (ICD-9-CM Version 2011)
C0006629 (UMLS CUI 2011AA)
261244009 (SNOMED CT 2011_0131)
CL414920 (UMLS CUI 2011AA)
C0348050 (UMLS CUI 2011AA)
105456007 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C1315037 (UMLS CUI 2011AA)
MTHU000083 (LOINC Version 232)
C0205280 (UMLS CUI 2011AA)
20323000 (SNOMED CT 2011_0131)
C1524057 (UMLS CUI 2011AA)
7883008 (SNOMED CT 2011_0131)
C0344389 (UMLS CUI 2011AA)
112143006 (SNOMED CT 2011_0131)
Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study
Item
Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0430061 (UMLS CUI 2011AA)
166435006 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Receiving or having previously received an organ transplant other than a kidney
Item
Receiving or having previously received an organ transplant other than a kidney
boolean
C1514756 (UMLS CUI 2011AA)
CL414906 (UMLS CUI 2011AA)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C0029216 (UMLS CUI 2011AA)
10061890 (MedDRA 14.1)
MTHU000173 (LOINC Version 232)
CL411789 (UMLS CUI 2011AA)
C0022646 (UMLS CUI 2011AA)
64033007 (SNOMED CT 2011_0131)
MTHU002935 (LOINC Version 232)
Cold ischemia time of the donor kidney > 30 hours
Item
Cold ischemia time of the donor kidney > 30 hours
boolean
C1563922 (UMLS CUI 2011AA)
MTHU020173 (LOINC Version 232)
C1720476 (UMLS CUI 2011AA)
420970005 (SNOMED CT 2011_0131)
C0439227 (UMLS CUI 2011AA)
258702006 (SNOMED CT 2011_0131)
HR, h (HL7 V3 2006_05)
Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawn of support awaiting cardiac arrest)
Item
Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawn of support awaiting cardiac arrest)
boolean
C1514756 (UMLS CUI 2011AA)
C0332835 (UMLS CUI 2011AA)
24486003 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0425583 (UMLS CUI 2011AA)
248646004 (SNOMED CT 2011_0131)
MTHU002606 (LOINC Version 232)
CL414920 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0683312 (UMLS CUI 2011AA)
MTHU018876 (LOINC Version 232)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C2349954 (UMLS CUI 2011AA)
C1521721 (UMLS CUI 2011AA)
CL370104 (UMLS CUI 2011AA)
C0018790 (UMLS CUI 2011AA)
410429000 (SNOMED CT 2011_0131)
10007515 (MedDRA 14.1)
I46 (ICD-10-CM Version 2010)
427.5 (ICD-9-CM Version 2011)
E10101 (CTCAE 1105E)
Significant liver disease, defined as having continuously elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels >= 2 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor
Item
Significant liver disease, defined as having continuously elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels >= 2 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
C0750536 (UMLS CUI 2011AA)
CL414623 (UMLS CUI 2011AA)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0201913 (UMLS CUI 2011AA)
359986008 (SNOMED CT 2011_0131)
10004696 (MedDRA 14.1)
C0456079 (UMLS CUI 2011AA)
276625007 (SNOMED CT 2011_0131)
CL384738 (UMLS CUI 2011AA)
C1519815 (UMLS CUI 2011AA)
C2825164 (UMLS CUI 2011AA)
CL414906 (UMLS CUI 2011AA)
C1514756 (UMLS CUI 2011AA)
C0332835 (UMLS CUI 2011AA)
24486003 (SNOMED CT 2011_0131)
C0856706 (UMLS CUI 2011AA)
10019738 (MedDRA 14.1)
C1112419 (UMLS CUI 2011AA)
10057394 (MedDRA 14.1)
CL414920 (UMLS CUI 2011AA)
Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
Item
Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
boolean
C1514873 (UMLS CUI 2011AA)
C0205265 (UMLS CUI 2011AA)
884001 (SNOMED CT 2011_0131)
C1705294 (UMLS CUI 2011AA)
CL419320 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0021081 (UMLS CUI 2011AA)
372823004, 69431002 (SNOMED CT 2011_0131)
C1298636 (UMLS CUI 2011AA)
108807002 (SNOMED CT 2011_0131)
Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation.
Item
Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation.
boolean
C1514873 (UMLS CUI 2011AA)
C0750536 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0021081 (UMLS CUI 2011AA)
372823004, 69431002 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0040732 (UMLS CUI 2011AA)
77465005 (SNOMED CT 2011_0131)
10057677 (MedDRA 14.1)
Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
Item
Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
CL415222 (UMLS CUI 2011AA)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C1443924 (UMLS CUI 2011AA)
409587002 (SNOMED CT 2011_0131)
C0042963 (UMLS CUI 2011AA)
249497008 (SNOMED CT 2011_0131)
10047700 (MedDRA 14.1)
MTHU013530 (LOINC Version 232)
R11.1 (ICD-10-CM Version 2010)
E11068 (CTCAE 1105E)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C1268997 (UMLS CUI 2011AA)
181244000 (SNOMED CT 2011_0131)
C0024523 (UMLS CUI 2011AA)
155841000 (SNOMED CT 2011_0131)
K90.4 (ICD-10-CM Version 2010)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0030920 (UMLS CUI 2011AA)
13200003 (SNOMED CT 2011_0131)
10034341 (MedDRA 14.1)
K27 (ICD-10-CM Version 2010)
533 (ICD-9-CM Version 2011)
Pregnant woman or breast-feeding mother
Item
Pregnant woman or breast-feeding mother
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0026591 (UMLS CUI 2011AA)
72705000 (SNOMED CT 2011_0131)
MTHU035602 (LOINC Version 232)
MTH (HL7 V3 2006_05)
Subject or donor known to be HIV positive
Item
Subject or donor known to be HIV positive
boolean
C0019699 (UMLS CUI 1)
C0681850 (UMLS CUI 1*1)
C0013018 (UMLS CUI 1*2)
Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, basiliximab or mycophenolate mofetil or any of the product excipients
Item
Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, basiliximab or mycophenolate mofetil or any of the product excipients
boolean
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C1744706 (UMLS CUI 2011AA)
C0085149 (UMLS CUI 2011AA)
386975001 (SNOMED CT 2011_0131)
MTHU001849 (LOINC Version 232)
C0003240 (UMLS CUI 2011AA)
372480009 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0676831 (UMLS CUI 2011AA)
386978004 (SNOMED CT 2011_0131)
C0209368 (UMLS CUI 2011AA)
386976000 (SNOMED CT 2011_0131)
CL407060 (UMLS CUI 2011AA)
C1514468 (UMLS CUI 2011AA)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully
Item
Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0205314 (UMLS CUI 2011AA)
7147002 (SNOMED CT 2011_0131)
C0332162 (UMLS CUI 2011AA)
77374008 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0040732 (UMLS CUI 2011AA)
77465005 (SNOMED CT 2011_0131)
10057677 (MedDRA 14.1)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
CL415147 (UMLS CUI 2011AA)
C1272703 (UMLS CUI 2011AA)
385669000 (SNOMED CT 2011_0131)
Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment
Item
Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1512806 (UMLS CUI 2011AA)
C0013230 (UMLS CUI 2011AA)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator
Item
Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator
boolean
CL407060 (UMLS CUI 2011AA)
C0740858 (UMLS CUI 2011AA)
66214007 (SNOMED CT 2011_0131)
10066169 (MedDRA 14.1)
MTHU019364 (LOINC Version 232)
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
C0009566 (UMLS CUI 2011AA)
116223007 (SNOMED CT 2011_0131)
MTHU008883 (LOINC Version 232)
C0009452 (UMLS CUI 2011AA)
263536004 (SNOMED CT 2011_0131)
MTHU021752 (LOINC Version 232)
CL102947 (UMLS CUI 2011AA)