ID
43089
Description
ODM derived from http://clinicaltrials.gov/show/NCT01363752
Link
http://clinicaltrials.gov/show/NCT01363752
Keywords
Versions (3)
- 4/11/13 4/11/13 - Martin Dugas
- 4/20/14 4/20/14 - Julian Varghese
- 9/20/21 9/20/21 -
Uploaded on
September 20, 2021
DOI
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License
Creative Commons BY 4.0
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Eligibility NCT01363752 Kidney Transplantation
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
Description
Receiving or having previously received an organ transplant other than a kidney
Data type
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
Description
Cold ischemia time of the donor kidney > 30 hours
Data type
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
Description
Panel Reactive Antibody (PRA) >20%
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1141951
- MedDRA 14.1
- 10058280
Description
Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawal of support awaiting cardiac arrest)
Data type
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
Description
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
Data type
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
- C0549178
- 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
Description
Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
Data type
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
- C0003250
- SNOMED CT 2011_0131
- 108807002
Description
Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation (other than minimal levels of immunosuppression following failure of previous transplantation without nephrectomy)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1514873
- UMLS CUI 2011AA
- C0549178
- 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
Description
Significant, uncontrolled concomitant infections and/ or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205318
- SNOMED CT 2011_0131
- 19032002
- UMLS CUI 2011AA
- CL415222
- UMLS CUI 2011AA
- C0009450
- 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
Description
Pregnant woman or breast-feeding mother
Data type
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
Description
Subject or donor known to be HIV positive
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0019699
Description
Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, sirolimus, MMF or any of the product excipients or iodine
Data type
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
Description
Evidence of malignant disease within the last 5 years, not including non-malignant skin cancers
Data type
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
Description
Currently participating in another clinical trial, and/ or has taken an investigational drug within 28 days prior to enrollment
Data type
boolean
Alias
- UMLS CUI 2011AA
- C2348568
Description
Unlikely to comply with the visits scheduled in the protocol
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0525058
- UMLS CUI 2011AA
- C0750558
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Eligibility
- StudyEvent: Eligibility
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