ID

5138

Beskrivning

ODM derived from http://clinicaltrials.gov/show/NCT01363752

Länk

http://clinicaltrials.gov/show/NCT01363752

Nyckelord

Versioner (3)
  1. 2013-04-11 2013-04-11 - Martin Dugas
  2. 2014-04-20 2014-04-20 - Julian Varghese
  3. 2021-09-20 2021-09-20 -
Uppladdad den

20 april 2014

DOI

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Licens

Creative Commons BY 4.0
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Eligibility NCT01363752 Kidney Transplantation

Tysk Engelsk

Eligibility

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beskrivning

Einschlusskriterien

Alter mindestens 18 Jahre
Beskrivning

age at least 18 Years

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 6 months)
Beskrivning

End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation (unless the graft was lost from rejection within 6 months)

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1261469
SNOMED CT 2011_0131
46177005
ICD-9-CM Version 2011
585.6
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1548635
HL7 V3 2006_05
ELG
UMLS CUI 2011AA
CL414904
UMLS CUI 2011AA
C0022671
SNOMED CT 2011_0131
70536003
MedDRA 14.1
10038533
ICD-9-CM Version 2011
55.6
UMLS CUI 2011AA
C0597409
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0332835
SNOMED CT 2011_0131
24486003
UMLS CUI 2011AA
C0745777
UMLS CUI 2011AA
C0018129
SNOMED CT 2011_0131
72627004
MedDRA 14.1
10044439
Receiving a kidney transplant from a deceased or living (non Human Leukocyte Antigen [HLA] identical) donor with compatible ABO blood type
Beskrivning

Receiving a kidney transplant from a deceased or living (non Human Leukocyte Antigen [HLA] identical) donor with compatible ABO blood type

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0401176
SNOMED CT 2011_0131
175902000
UMLS CUI 2011AA
C0401177
SNOMED CT 2011_0131
175901007
UMLS CUI 2011AA
C1524057
SNOMED CT 2011_0131
7883008
UMLS CUI 2011AA
C0344389
SNOMED CT 2011_0131
112143006
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1315037
LOINC Version 232
MTHU000083
UMLS CUI 2011AA
C0205280
SNOMED CT 2011_0131
20323000
Female subject of childbearing potential has a negative serum or urine pregnancy test at enrollment
Beskrivning

Female subject of childbearing potential has a negative serum or urine pregnancy test at enrollment

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0430061
SNOMED CT 2011_0131
166435006
UMLS CUI 2011AA
C0430057
SNOMED CT 2011_0131
167254001
MedDRA 14.1
10036577
UMLS CUI 2011AA
C1516879
Female and male subjects agree to maintain highly effective birth control during the study and for 90 days after discontinuation of dosing with study drugs. A highly effective method of birth control is defined as those which result in a low failure rate (CPMP/ ICH/ 286/ 95 modified) of < 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some Intrauterine Devises (IUDs), sexual abstinence or vasectomized partner
Beskrivning

Female and male subjects agree to maintain highly effective birth control during the study and for 90 days after discontinuation of dosing with study drugs. A highly effective method of birth control is defined as those which result in a low failure rate (CPMP/ ICH/ 286/ 95 modified) of < 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some Intrauterine Devises (IUDs), sexual abstinence or vasectomized partner

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0024554
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
CL424925
UMLS CUI 2011AA
C1262153
MedDRA 14.1
10062577
UMLS CUI 2011AA
C0457572
SNOMED CT 2011_0131
268458002
UMLS CUI 2011AA
C0021900
SNOMED CT 2011_0131
268460000
MedDRA 14.1
10022745
UMLS CUI 2011AA
C0036899
SNOMED CT 2011_0131
47037006
MedDRA 14.1
10029805
UMLS CUI 2011AA
C0420842
SNOMED CT 2011_0131
268457007
Ausschlusskriterien
Beskrivning

Ausschlusskriterien

Receiving or having previously received an organ transplant other than a kidney
Beskrivning

Receiving or having previously received an organ transplant other than a kidney

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0029216
MedDRA 14.1
10061890
LOINC Version 232
MTHU000173
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0022671
SNOMED CT 2011_0131
70536003
MedDRA 14.1
10038533
ICD-9-CM Version 2011
55.6
Cold ischemia time of the donor kidney > 30 hours
Beskrivning

Cold ischemia time of the donor kidney > 30 hours

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1563922
LOINC Version 232
MTHU020173
UMLS CUI 2011AA
C1720476
SNOMED CT 2011_0131
420970005
UMLS CUI 2011AA
C0439227
SNOMED CT 2011_0131
258702006
HL7 V3 2006_05
HR, h
Panel-reactive antibody
Beskrivning

Panel Reactive Antibody (PRA) >20%

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1141951
MedDRA 14.1
10058280
Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawal of support awaiting cardiac arrest)
Beskrivning

Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawal of support awaiting cardiac arrest)

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0332835
SNOMED CT 2011_0131
24486003
UMLS CUI 2011AA
C0425595
SNOMED CT 2011_0131
399151004
UMLS CUI 2011AA
CL414920
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C2349954
UMLS CUI 2011AA
C1521721
UMLS CUI 2011AA
C0018790
SNOMED CT 2011_0131
410429000
MedDRA 14.1
10007515
ICD-10-CM Version 2010
I46
ICD-9-CM Version 2011
427.5
CTCAE 1105E
E10101
UMLS CUI 2011AA
C1517001
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
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0023895
SNOMED CT 2011_0131
235856003
MedDRA 14.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
UMLS CUI 2011AA
C0750536
UMLS CUI 2011AA
CL414623
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C0201913
SNOMED CT 2011_0131
359986008
MedDRA 14.1
10004696
UMLS CUI 2011AA
C0456079
SNOMED CT 2011_0131
276625007
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0332835
SNOMED CT 2011_0131
24486003
UMLS CUI 2011AA
C1112419
MedDRA 14.1
10057394
UMLS CUI 2011AA
C0856706
MedDRA 14.1
10019738
UMLS CUI 2011AA
CL414920
Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
Beskrivning

Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s)

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0205265
SNOMED CT 2011_0131
884001
UMLS CUI 2011AA
C1705294
UMLS CUI 2011AA
CL419320
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0021079
SNOMED CT 2011_0131
86553008
UMLS CUI 2011AA
C1298636
SNOMED CT 2011_0131
108807002
Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation (other than minimal levels of immunosuppression following failure of previous transplantation without nephrectomy)
Beskrivning

Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation (other than minimal levels of immunosuppression following failure of previous transplantation without nephrectomy)

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0750536
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0021081
SNOMED CT 2011_0131
372823004, 69431002
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0040732
SNOMED CT 2011_0131
77465005
MedDRA 14.1
10057677
Significant, uncontrolled concomitant infections and/ or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
Beskrivning

Significant, uncontrolled concomitant infections and/ or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
CL415222
UMLS CUI 2011AA
C0021311
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C1443924
SNOMED CT 2011_0131
409587002
UMLS CUI 2011AA
C0042963
SNOMED CT 2011_0131
249497008
MedDRA 14.1
10047700
LOINC Version 232
MTHU013530
ICD-10-CM Version 2010
R11.1
CTCAE 1105E
E11068
UMLS CUI 2011AA
C1268997
SNOMED CT 2011_0131
181244000
UMLS CUI 2011AA
C0024523
SNOMED CT 2011_0131
155841000
ICD-10-CM Version 2010
K90.4
UMLS CUI 2011AA
C0030920
SNOMED CT 2011_0131
13200003
MedDRA 14.1
10034341
ICD-10-CM Version 2010
K27
ICD-9-CM Version 2011
533
Pregnant woman or breast-feeding mother
Beskrivning

Pregnant woman or breast-feeding mother

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
C0026591
SNOMED CT 2011_0131
72705000
LOINC Version 232
MTHU035602
HL7 V3 2006_05
MTH
Subject or donor known to be HIV positive
Beskrivning

Subject or donor known to be HIV positive

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0019699
Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, sirolimus, MMF or any of the product excipients or iodine
Beskrivning

Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, sirolimus, MMF or any of the product excipients or iodine

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C1744706
UMLS CUI 2011AA
C0085149
SNOMED CT 2011_0131
386975001
LOINC Version 232
MTHU001849
UMLS CUI 2011AA
C0003240
SNOMED CT 2011_0131
372480009
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
C0072980
SNOMED CT 2011_0131
387014003
LOINC Version 232
MTHU013897
UMLS CUI 2011AA
C0209368
SNOMED CT 2011_0131
386976000
UMLS CUI 2011AA
C0015237
SNOMED CT 2011_0131
360215002
UMLS CUI 2011AA
C0021968
SNOMED CT 2011_0131
325330005
LOINC Version 232
MTHU009375
Evidence of malignant disease within the last 5 years, not including non-malignant skin cancers
Beskrivning

Evidence of malignant disease within the last 5 years, not including non-malignant skin cancers

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C1518371
UMLS CUI 2011AA
C0699893
MedDRA 14.1
10040810
Currently participating in another clinical trial, and/ or has taken an investigational drug within 28 days prior to enrollment
Beskrivning

Currently participating in another clinical trial, and/ or has taken an investigational drug within 28 days prior to enrollment

Datatyp

boolean

Alias
UMLS CUI 2011AA
C2348568
Unlikely to comply with the visits scheduled in the protocol
Beskrivning

Unlikely to comply with the visits scheduled in the protocol

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0525058
UMLS CUI 2011AA
C0750558
Tillbaka till toppen

Similar models

Eligibility

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Einschlusskriterien
age at least 18 Years
Item
Alter mindestens 18 Jahre
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 6 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 6 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)
Receiving a kidney transplant from a deceased or living (non Human Leukocyte Antigen [HLA] identical) donor with compatible ABO blood type
Item
Receiving a kidney transplant from a deceased or living (non Human Leukocyte Antigen [HLA] identical) donor with compatible ABO blood type
boolean
C1514756 (UMLS CUI 2011AA)
C0401176 (UMLS CUI 2011AA)
175902000 (SNOMED CT 2011_0131)
C0401177 (UMLS CUI 2011AA)
175901007 (SNOMED CT 2011_0131)
C1524057 (UMLS CUI 2011AA)
7883008 (SNOMED CT 2011_0131)
C0344389 (UMLS CUI 2011AA)
112143006 (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)
Female subject of childbearing potential has a negative serum or urine pregnancy test at enrollment
Item
Female subject of childbearing potential has a negative serum or urine pregnancy test at enrollment
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)
C0430057 (UMLS CUI 2011AA)
167254001 (SNOMED CT 2011_0131)
10036577 (MedDRA 14.1)
C1516879 (UMLS CUI 2011AA)
Female and male subjects agree to maintain highly effective birth control during the study and for 90 days after discontinuation of dosing with study drugs. A highly effective method of birth control is defined as those which result in a low failure rate (CPMP/ ICH/ 286/ 95 modified) of < 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some Intrauterine Devises (IUDs), sexual abstinence or vasectomized partner
Item
Female and male subjects agree to maintain highly effective birth control during the study and for 90 days after discontinuation of dosing with study drugs. A highly effective method of birth control is defined as those which result in a low failure rate (CPMP/ ICH/ 286/ 95 modified) of < 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some Intrauterine Devises (IUDs), sexual abstinence or vasectomized partner
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
CL424925 (UMLS CUI 2011AA)
C1262153 (UMLS CUI 2011AA)
10062577 (MedDRA 14.1)
C0457572 (UMLS CUI 2011AA)
268458002 (SNOMED CT 2011_0131)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
C0036899 (UMLS CUI 2011AA)
47037006 (SNOMED CT 2011_0131)
10029805 (MedDRA 14.1)
C0420842 (UMLS CUI 2011AA)
268457007 (SNOMED CT 2011_0131)
Item Group
Ausschlusskriterien
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)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0029216 (UMLS CUI 2011AA)
10061890 (MedDRA 14.1)
MTHU000173 (LOINC Version 232)
CL411789 (UMLS CUI 2011AA)
C0022671 (UMLS CUI 2011AA)
70536003 (SNOMED CT 2011_0131)
10038533 (MedDRA 14.1)
55.6 (ICD-9-CM Version 2011)
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)
Panel Reactive Antibody (PRA) >20%
Item
Panel-reactive antibody
boolean
C1141951 (UMLS CUI 2011AA)
10058280 (MedDRA 14.1)
Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawal of support awaiting cardiac arrest)
Item
Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawal of support awaiting cardiac arrest)
boolean
C1514756 (UMLS CUI 2011AA)
C0332835 (UMLS CUI 2011AA)
24486003 (SNOMED CT 2011_0131)
C0425595 (UMLS CUI 2011AA)
399151004 (SNOMED CT 2011_0131)
CL414920 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
C2349954 (UMLS CUI 2011AA)
C1521721 (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)
C1517001 (UMLS CUI 2011AA)
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)
C1514756 (UMLS CUI 2011AA)
C0332835 (UMLS CUI 2011AA)
24486003 (SNOMED CT 2011_0131)
C1112419 (UMLS CUI 2011AA)
10057394 (MedDRA 14.1)
C0856706 (UMLS CUI 2011AA)
10019738 (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)
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)
C1298636 (UMLS CUI 2011AA)
108807002 (SNOMED CT 2011_0131)
Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation (other than minimal levels of immunosuppression following failure of previous transplantation without nephrectomy)
Item
Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation (other than minimal levels of immunosuppression following failure of previous transplantation without nephrectomy)
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
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)
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)
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 2011AA)
Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, sirolimus, MMF or any of the product excipients or iodine
Item
Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, sirolimus, MMF or any of the product excipients or iodine
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)
C0072980 (UMLS CUI 2011AA)
387014003 (SNOMED CT 2011_0131)
MTHU013897 (LOINC Version 232)
C0209368 (UMLS CUI 2011AA)
386976000 (SNOMED CT 2011_0131)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
C0021968 (UMLS CUI 2011AA)
325330005 (SNOMED CT 2011_0131)
MTHU009375 (LOINC Version 232)
Evidence of malignant disease within the last 5 years, not including non-malignant skin cancers
Item
Evidence of malignant disease within the last 5 years, not including non-malignant skin cancers
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (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)
CL411789 (UMLS CUI 2011AA)
C1518371 (UMLS CUI 2011AA)
C0699893 (UMLS CUI 2011AA)
10040810 (MedDRA 14.1)
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
C2348568 (UMLS CUI 2011AA)
Unlikely to comply with the visits scheduled in the protocol
Item
Unlikely to comply with the visits scheduled in the protocol
boolean
C0525058 (UMLS CUI 2011AA)
C0750558 (UMLS CUI 2011AA)
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