Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 18 Years to 75 Years
Item
age 18 Years to 75 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Post mortal kidney donation or living donation
Item
Post mortal kidney donation or living donation
boolean
C0455636 (UMLS CUI 2011AA)
161659007 (SNOMED CT 2011_0131)
C0006629 (UMLS CUI 2011AA)
261244009 (SNOMED CT 2011_0131)
C0348050 (UMLS CUI 2011AA)
105456007 (SNOMED CT 2011_0131)
Primary and secondary renal transplantation, unless the graft was lost due to severe rejection within the first year
Item
Primary and secondary renal transplantation, unless the graft was lost due to severe rejection within the first year
boolean
CL414904 (UMLS CUI 2011AA)
C0175668 (UMLS CUI 2011AA)
2603003 (SNOMED CT 2011_0131)
C0022671 (UMLS CUI 2011AA)
70536003 (SNOMED CT 2011_0131)
10038533 (MedDRA 14.1)
55.6 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
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)
PRA level <= 20%.
Item
PRA level <= 20%.
boolean
C1141951 (UMLS CUI 2011AA)
10058280 (MedDRA 14.1)
C0456079 (UMLS CUI 2011AA)
276625007 (SNOMED CT 2011_0131)
AB0-compatible
Item
AB0-compatible
boolean
C0344389 (UMLS CUI 2011AA)
112143006 (SNOMED CT 2011_0131)
C1524057 (UMLS CUI 2011AA)
7883008 (SNOMED CT 2011_0131)
Negative crossmatch
Item
Negative crossmatch
boolean
CL415098 (UMLS CUI 2011AA)
C0855279 (UMLS CUI 2011AA)
10011412 (MedDRA 14.1)
Patients with a signed informed consent form
Item
Patient's Signature on Informed Consent Form
boolean
C2348583 (UMLS CUI 2011AA)
Women of child-bearing age must agree to an efficient contraception
Item
Women of child-bearing age must agree to an efficient contraception
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Third or multiple transplantation
Item
Third or multiple transplantation
boolean
C0205437 (UMLS CUI 2011AA)
70905002 (SNOMED CT 2011_0131)
C0439064 (UMLS CUI 2011AA)
255204007 (SNOMED CT 2011_0131)
C0040732 (UMLS CUI 2011AA)
77465005 (SNOMED CT 2011_0131)
10057677 (MedDRA 14.1)
Transplantation per a non-heart beating donor
Item
Transplantation per a non-heart beating donor
boolean
C0040732 (UMLS CUI 2011AA)
77465005 (SNOMED CT 2011_0131)
10057677 (MedDRA 14.1)
C1518422 (UMLS CUI 2011AA)
C0425583 (UMLS CUI 2011AA)
248646004 (SNOMED CT 2011_0131)
MTHU002606 (LOINC Version 232)
CL414920 (UMLS CUI 2011AA)
HLA-identical living donation
Item
HLA-identical living donation
boolean
C1315037 (UMLS CUI 2011AA)
MTHU000083 (LOINC Version 232)
C0205280 (UMLS CUI 2011AA)
20323000 (SNOMED CT 2011_0131)
C0348050 (UMLS CUI 2011AA)
105456007 (SNOMED CT 2011_0131)
Incompatibility to study medication (allergy, intolerance, hypersensitivity)
Item
Incompatibility to study medication (allergy, intolerance, hypersensitivity)
boolean
C0679426 (UMLS CUI 2011AA)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
CL415164 (UMLS CUI 2011AA)
OINT (HL7 V3 2006_05)
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
Patients with existing malignant underlying disease or tumour anamnesis < 5 years. Exception: basaloma or squamous cell carcinoma of the skin after successful therapy
Item
Patients with existing malignant underlying disease or tumour anamnesis < 5 years. Exception: basaloma or squamous cell carcinoma of the skin after successful therapy
boolean
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0021055 (UMLS CUI 2011AA)
940000 (SNOMED CT 2011_0131)
C1554961 (UMLS CUI 2011AA)
C0597967 (UMLS CUI 2011AA)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C1272703 (UMLS CUI 2011AA)
385669000 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
Female patients who do not use a safe method of contraception
Item
Female patients who do not use a safe method of contraception
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0420844 (UMLS CUI 2011AA)
169450001 (SNOMED CT 2011_0131)
Patients with clinically significant, uncontrolled infectious diseases (incl. HIV) and/or severe diarrhoea, emesis, active malabsorption of the upper gastrointestinal tract or active peptic ulcer
Item
Patients with clinically significant, uncontrolled infectious diseases (incl. HIV) and/or severe diarrhoea, emesis, active malabsorption of the upper gastrointestinal tract or active peptic ulcer
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
40733004 (SNOMED CT 2011_0131)
10021881 (MedDRA 14.1)
MTHU034915 (LOINC Version 232)
136.9 (ICD-9-CM Version 2011)
C0019682 (UMLS CUI 2011AA)
19030005 (SNOMED CT 2011_0131)
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)
C0024523 (UMLS CUI 2011AA)
155841000 (SNOMED CT 2011_0131)
K90.4 (ICD-10-CM Version 2010)
C1268997 (UMLS CUI 2011AA)
181244000 (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)
Patients currently, resp. within the last 30 days, participating in other studies
Item
Patients currently, resp. within the last 30 days, participating in other studies
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)
Primary focal-sclerosing glomerulonephritis and membranoproliferative glomerulonephritis as an underlying disease
Item
Primary focal-sclerosing glomerulonephritis and membranoproliferative glomerulonephritis as an underlying disease
boolean
CL414904 (UMLS CUI 2011AA)
C0205234 (UMLS CUI 2011AA)
87017008 (SNOMED CT 2011_0131)
C0268748 (UMLS CUI 2011AA)
13335004 (SNOMED CT 2011_0131)
C0017662 (UMLS CUI 2011AA)
80321008 (SNOMED CT 2011_0131)
10018370 (MedDRA 14.1)
Autoimmune disease as underlying disease (collagen diseases, colitis, HUS, SLE) which might require chronic cortisone therapy
Item
Autoimmune disease as underlying disease (collagen diseases, colitis, HUS, SLE) which might require chronic cortisone therapy
boolean
C0004364 (UMLS CUI 2011AA)
85828009 (SNOMED CT 2011_0131)
10061664 (MedDRA 14.1)
M30-M36 (ICD-10-CM Version 2010)
E11258 (CTCAE 1105E)
C0009326 (UMLS CUI 2011AA)
81573002 (SNOMED CT 2011_0131)
10009903 (MedDRA 14.1)
C0009319 (UMLS CUI 2011AA)
64226004 (SNOMED CT 2011_0131)
10009887 (MedDRA 14.1)
K52.9 (ICD-10-CM Version 2010)
E10521 (CTCAE 1105E)
C0019061 (UMLS CUI 2011AA)
111407006 (SNOMED CT 2011_0131)
10018932 (MedDRA 14.1)
D59.3 (ICD-10-CM Version 2010)
283.11 (ICD-9-CM Version 2011)
E10043 (CTCAE 1105E)
C0024141 (UMLS CUI 2011AA)
55464009 (SNOMED CT 2011_0131)
10042945 (MedDRA 14.1)
M32.9 (ICD-10-CM Version 2010)
710.0 (ICD-9-CM Version 2011)
C1514873 (UMLS CUI 2011AA)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0010137 (UMLS CUI 2011AA)
32498003 (SNOMED CT 2011_0131)
MTHU004611 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
Additional disease requiring temporary or chronic cortisone therapy (including inhalation medicine)
Item
Additional disease requiring temporary or chronic cortisone therapy (including inhalation medicine)
boolean
C1524062 (UMLS CUI 2011AA)
MTHU013802 (LOINC Version 232)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
C0205374 (UMLS CUI 2011AA)
14803004 (SNOMED CT 2011_0131)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0010137 (UMLS CUI 2011AA)
32498003 (SNOMED CT 2011_0131)
MTHU004611 (LOINC Version 232)
C0039798 (UMLS CUI 2011AA)
CL426883 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
Chronic hepatitis B and hepatitis C infection
Item
Chronic hepatitis B and hepatitis C infection
boolean
C0524909 (UMLS CUI 2011AA)
61977001 (SNOMED CT 2011_0131)
10008910 (MedDRA 14.1)
B18.1 (ICD-10-CM Version 2010)
C0524910 (UMLS CUI 2011AA)
128302006 (SNOMED CT 2011_0131)
10008912 (MedDRA 14.1)
B18.2 (ICD-10-CM Version 2010)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
Thrombopenia < 70.000/mm3 or leukopenia < 2.500/mm3 or neutropenia < 1500/ mm3.
Item
Thrombopenia < 70.000/mm3 or leukopenia < 2.500/mm3 or neutropenia < 1500/ mm3.
boolean
C0040034 (UMLS CUI 2011AA)
302215000 (SNOMED CT 2011_0131)
10043554 (MedDRA 14.1)
D69.6 (ICD-10-CM Version 2010)
287.5 (ICD-9-CM Version 2011)
E12207 (CTCAE 1105E)
C0023530 (UMLS CUI 2011AA)
84828003 (SNOMED CT 2011_0131)
10024384 (MedDRA 14.1)
D72.819 (ICD-10-CM Version 2010)
288.50 (ICD-9-CM Version 2011)
E12232 (CTCAE 1105E)
C0853697 (UMLS CUI 2011AA)
10029366 (MedDRA 14.1)
E12198 (CTCAE 1105E)
Patients with hepatocirrhosis Child B or C or another severe disease of the liver
Item
Patients with hepatocirrhosis Child B or C or another severe disease of the liver
boolean
C0023890 (UMLS CUI 2011AA)
19943007 (SNOMED CT 2011_0131)
10019641 (MedDRA 14.1)
K74.60 (ICD-10-CM Version 2010)
C2347612 (UMLS CUI 2011AA)
C0439105 (UMLS CUI 2011AA)
421151005 (SNOMED CT 2011_0131)
C0439106 (UMLS CUI 2011AA)
257962003 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (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)
Patients with symptoms of a significant somatic or psychiatric / mental illness. Patients who are not able to realize nature, relevance and consequences of the clinical trial and who are not able to comply, to cooperate and communicate adequately and to follow the instructions of the study or even to give their informed consent (according to § 40 article 4 and § 41 article 2 and 3 AMG).
Item
Patients with symptoms of a significant somatic or psychiatric / mental illness. Patients who are not able to realize nature, relevance and consequences of the clinical trial and who are not able to comply, to cooperate and communicate adequately and to follow the instructions of the study or even to give their informed consent (according to § 40 article 4 and § 41 article 2 and 3 AMG).
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
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)
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0392337 (UMLS CUI 2011AA)
C0009452 (UMLS CUI 2011AA)
263536004 (SNOMED CT 2011_0131)
MTHU021752 (LOINC Version 232)
C0184704 (UMLS CUI 2011AA)
55149002 (SNOMED CT 2011_0131)
Patients who possibly depend on the sponsor or the trial physician
Item
Patients who possibly depend on the sponsor or the trial physician
boolean
CL414916 (UMLS CUI 2011AA)
C2347796 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0031831 (UMLS CUI 2011AA)
309343006 (SNOMED CT 2011_0131)
MTHU010489 (LOINC Version 232)
PHYS (HL7 V3 2006_05)
Patients with signs of drug abuse or alcohol abuse
Item
Patients with signs of drug abuse or alcohol abuse
boolean
C0013146 (UMLS CUI 2011AA)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
C0085762 (UMLS CUI 2011AA)
15167005 (SNOMED CT 2011_0131)
10001584 (MedDRA 14.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
Patients taking additional medicines with known interactions with the immune suppressive substances (MMF and tacrolimus) that preclude an adequate control of the immunosuppression
Item
Patients taking additional medicines with known interactions with the immune suppressive substances (MMF and tacrolimus) that preclude an adequate control of the immunosuppression
boolean
C1512806 (UMLS CUI 2011AA)
C1524062 (UMLS CUI 2011AA)
MTHU013802 (LOINC Version 232)
C0013227 (UMLS CUI 2011AA)
C1704675 (UMLS CUI 2011AA)
C0021081 (UMLS CUI 2011AA)
372823004, 69431002 (SNOMED CT 2011_0131)
C0209368 (UMLS CUI 2011AA)
386976000 (SNOMED CT 2011_0131)
C0085149 (UMLS CUI 2011AA)
386975001 (SNOMED CT 2011_0131)
MTHU001849 (LOINC Version 232)
C0332196 (UMLS CUI 2011AA)
77765009 (SNOMED CT 2011_0131)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)
Cold ischemia time of donor kidney > 30 hours
Item
Cold ischemia time of donor kidney > 30 hours
boolean
C1563922 (UMLS CUI 2011AA)
MTHU020173 (LOINC Version 232)
C1720476 (UMLS CUI 2011AA)
420970005 (SNOMED CT 2011_0131)
Pregnant or nursing patients
Item
Pregnant or nursing patients
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
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