Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
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 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
C0086287 (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
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0086582 (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
Exclusion Criteria
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)
C0549178 (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)
C0003250 (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)
C0549178 (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)
C0009450 (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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