ID

43800

Description

ODM derived from http://clinicaltrials.gov/show/NCT00724022

Link

http://clinicaltrials.gov/show/NCT00724022

Keywords

Versions (4)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/16/14 4/16/14 - Julian Varghese
  3. 6/21/17 6/21/17 - Martin Dugas
  4. 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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Triple Arm, Prospectively Randomized Multi Centre Study Phase IV to Evaluate Calcineurin Inhibitor Reduced, Steroid Free Immunosuppression After Renal Transplantation in Non-risk Patients DRKS00000452 NCT00724022 DRKS00000452

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
age 18 Years to 75 Years
Description

age 18 Years to 75 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Post mortal kidney donation or living donation
Description

Post mortal kidney donation or living donation

Data type

boolean

Alias
SNOMED CT 2011_0131
161659007
SNOMED CT 2011_0131
261244009
SNOMED CT 2011_0131
105456007
UMLS CUI [1,1]
C0455636
UMLS CUI [1,2]
C0006629
UMLS CUI [1,3]
C0348050
Primary and secondary renal transplantation, unless the graft was lost due to severe rejection within the first year
Description

Primary and secondary renal transplantation, unless the graft was lost due to severe rejection within the first year

Data type

boolean

Alias
SNOMED CT 2011_0131
2603003
SNOMED CT 2011_0131
70536003
MedDRA 14.1
10038533
ICD-9-CM Version 2011
55.6
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
HL7 V3 2006_05
E
SNOMED CT 2011_0131
24486003
SNOMED CT 2011_0131
72627004
MedDRA 14.1
10044439
UMLS CUI [1,1]
C0022671
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0175668
PRA level <= 20%.
Description

Panel-reactive antibody level

Data type

boolean

Alias
MedDRA 14.1
10058280
SNOMED CT 2011_0131
276625007
UMLS CUI [1]
C1141951
AB0-compatible
Description

AB0-compatible

Data type

boolean

Alias
UMLS CUI 2011AA
C0344389
SNOMED CT 2011_0131
112143006
UMLS CUI 2011AA
C1524057
SNOMED CT 2011_0131
7883008
Negative crossmatch
Description

Crossmatch incompatible

Data type

boolean

Alias
MedDRA 14.1
10011412
UMLS CUI [1]
C0855281
Patient's Signature on Informed Consent Form
Description

Patients with a signed informed consent form

Data type

boolean

Alias
UMLS CUI 2011AA
C2348583
Women of child-bearing age must agree to an efficient contraception
Description

Women of child-bearing age must agree to an efficient contraception

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Third or multiple transplantation
Description

Third or multiple transplantation

Data type

boolean

Alias
UMLS CUI 2011AA
C0205437
SNOMED CT 2011_0131
70905002
UMLS CUI 2011AA
C0439064
SNOMED CT 2011_0131
255204007
UMLS CUI 2011AA
C0040732
SNOMED CT 2011_0131
77465005
MedDRA 14.1
10057677
Transplantation per a non-heart beating donor
Description

Transplantation per a non-heart beating donor

Data type

boolean

Alias
UMLS CUI 2011AA
C0040732
SNOMED CT 2011_0131
77465005
MedDRA 14.1
10057677
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0425583
SNOMED CT 2011_0131
248646004
LOINC Version 232
MTHU002606
UMLS CUI 2011AA
CL414920
HLA-identical living donation
Description

HLA-identical living donation

Data type

boolean

Alias
UMLS CUI 2011AA
C1315037
LOINC Version 232
MTHU000083
UMLS CUI 2011AA
C0205280
SNOMED CT 2011_0131
20323000
UMLS CUI 2011AA
C0348050
SNOMED CT 2011_0131
105456007
Incompatibility to study medication (allergy, intolerance, hypersensitivity)
Description

Incompatibility to study medication

Data type

boolean

Alias
SNOMED CT 2011_0131
902003
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
HL7 V3 2006_05
OINT
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
Patients with existing malignant underlying disease or tumour anamnesis < 5 years. Exception: basaloma or squamous cell carcinoma of the skin after successful therapy
Description

Patients with existing malignant underlying disease or tumour anamnesis < 5 years. Exception: basaloma or squamous cell carcinoma of the skin after successful therapy

Data type

boolean

Alias
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
C0021055
SNOMED CT 2011_0131
940000
UMLS CUI 2011AA
C1554961
UMLS CUI 2011AA
C0597967
UMLS CUI 2011AA
C0553723
SNOMED CT 2011_0131
254651007
MedDRA 14.1
10041834
UMLS CUI 2011AA
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C1272703
SNOMED CT 2011_0131
385669000
UMLS CUI 2011AA
C0039798
Female patients who do not use a safe method of contraception
Description

Female patients who do not use a safe method of contraception

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0420844
SNOMED CT 2011_0131
169450001
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
Description

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

Data type

boolean

Alias
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
40733004
MedDRA 14.1
10021881
LOINC Version 232
MTHU034915
ICD-9-CM Version 2011
136.9
UMLS CUI 2011AA
C0019682
SNOMED CT 2011_0131
19030005
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
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0024523
SNOMED CT 2011_0131
155841000
ICD-10-CM Version 2010
K90.4
UMLS CUI 2011AA
C1268997
SNOMED CT 2011_0131
181244000
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
Patients currently, resp. within the last 30 days, participating in other studies
Description

Patients currently, resp. within the last 30 days, participating in other studies

Data type

boolean

Alias
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Primary focal-sclerosing glomerulonephritis and membranoproliferative glomerulonephritis as an underlying disease
Description

Primary focal-sclerosing glomerulonephritis and membranoproliferative glomerulonephritis

Data type

boolean

Alias
SNOMED CT 2011_0131
87017008
SNOMED CT 2011_0131
13335004
SNOMED CT 2011_0131
80321008
MedDRA 14.1
10018370
UMLS CUI [1,1]
C0017668
UMLS CUI [1,2]
C0017662
Autoimmune disease as underlying disease (collagen diseases, colitis, HUS, SLE) which might require chronic cortisone therapy
Description

Autoimmune disease as underlying disease (collagen diseases, colitis, HUS, SLE) which might require chronic cortisone therapy

Data type

boolean

Alias
UMLS CUI 2011AA
C0004364
SNOMED CT 2011_0131
85828009
MedDRA 14.1
10061664
ICD-10-CM Version 2010
M30-M36
CTCAE 1105E
E11258
UMLS CUI 2011AA
C0009326
SNOMED CT 2011_0131
81573002
MedDRA 14.1
10009903
UMLS CUI 2011AA
C0009319
SNOMED CT 2011_0131
64226004
MedDRA 14.1
10009887
ICD-10-CM Version 2010
K52.9
CTCAE 1105E
E10521
UMLS CUI 2011AA
C0019061
SNOMED CT 2011_0131
111407006
MedDRA 14.1
10018932
ICD-10-CM Version 2010
D59.3
ICD-9-CM Version 2011
283.11
CTCAE 1105E
E10043
UMLS CUI 2011AA
C0024141
SNOMED CT 2011_0131
55464009
MedDRA 14.1
10042945
ICD-10-CM Version 2010
M32.9
ICD-9-CM Version 2011
710.0
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C0010137
SNOMED CT 2011_0131
32498003
LOINC Version 232
MTHU004611
UMLS CUI 2011AA
C0039798
Additional disease requiring temporary or chronic cortisone therapy (including inhalation medicine)
Description

Additional disease requiring temporary or chronic cortisone therapy (including inhalation medicine)

Data type

boolean

Alias
UMLS CUI 2011AA
C1524062
LOINC Version 232
MTHU013802
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0205374
SNOMED CT 2011_0131
14803004
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C0010137
SNOMED CT 2011_0131
32498003
LOINC Version 232
MTHU004611
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
CL426883
UMLS CUI 2011AA
C0013227
Chronic hepatitis B and hepatitis C infection
Description

Chronic hepatitis B and hepatitis C infection

Data type

boolean

Alias
UMLS CUI 2011AA
C0524909
SNOMED CT 2011_0131
61977001
MedDRA 14.1
10008910
ICD-10-CM Version 2010
B18.1
UMLS CUI 2011AA
C0524910
SNOMED CT 2011_0131
128302006
MedDRA 14.1
10008912
ICD-10-CM Version 2010
B18.2
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
Thrombopenia < 70.000/mm3 or leukopenia < 2.500/mm3 or neutropenia < 1500/ mm3.
Description

Thrombopenia, leukopenia or neutropenia

Data type

boolean

Alias
SNOMED CT 2011_0131
302215000
MedDRA 14.1
10043554
ICD-10-CM Version 2010
D69.6
ICD-9-CM Version 2011
287.5
CTCAE 1105E
E12207
SNOMED CT 2011_0131
84828003
MedDRA 14.1
10024384
ICD-10-CM Version 2010
D72.819
ICD-9-CM Version 2011
288.50
CTCAE 1105E
E12232
MedDRA 14.1
10029366
CTCAE 1105E
E12198
UMLS CUI [1,1]
C0040034
UMLS CUI [1,2]
C0023530
UMLS CUI [1,3]
C0853697
Patients with hepatocirrhosis Child B or C or another severe disease of the liver
Description

Patients with hepatocirrhosis Child B or C or another severe disease of the liver

Data type

boolean

Alias
UMLS CUI 2011AA
C0023890
SNOMED CT 2011_0131
19943007
MedDRA 14.1
10019641
ICD-10-CM Version 2010
K74.60
UMLS CUI 2011AA
C4050412
UMLS CUI 2011AA
C0439105
SNOMED CT 2011_0131
421151005
UMLS CUI 2011AA
C0439106
SNOMED CT 2011_0131
257962003
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
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
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).
Description

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).

Data type

boolean

Alias
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0004936
SNOMED CT 2011_0131
74732009
MedDRA 14.1
10037174
ICD-10-CM Version 2010
F99
ICD-9-CM Version 2011
290-319.99
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C0392337
UMLS CUI 2011AA
C0009452
SNOMED CT 2011_0131
263536004
LOINC Version 232
MTHU021752
UMLS CUI 2011AA
C0184704
SNOMED CT 2011_0131
55149002
Patients who possibly depend on the sponsor or the trial physician
Description

Patient dependency

Data type

boolean

Alias
SNOMED CT 2011_0131
110465008
SNOMED CT 2011_0131
309343006
LOINC Version 232
MTHU010489
HL7 V3 2006_05
PHYS
UMLS CUI [1]
C0011547
Patients with signs of drug abuse or alcohol abuse
Description

Patients with signs of drug abuse or alcohol abuse

Data type

boolean

Alias
UMLS CUI 2011AA
C0237123
ICD-10-CM Version 2010
F10.1
ICD-9-CM Version 2011
305.0
Patients taking additional medicines with known interactions with the immune suppressive substances (MMF and tacrolimus) that preclude an adequate control of the immunosuppression
Description

medicines with interactions with immune suppressive substances

Data type

boolean

Alias
LOINC Version 232
MTHU013802
SNOMED CT 2011_0131
372823004, 69431002
SNOMED CT 2011_0131
386976000
SNOMED CT 2011_0131
386975001
LOINC Version 232
MTHU001849
SNOMED CT 2011_0131
77765009
SNOMED CT 2011_0131
31509003
SNOMED CT 2011_0131
86553008
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1704675
UMLS CUI [1,3]
C0021081
Cold ischemia time of donor kidney > 30 hours
Description

Cold ischemia time of donor kidney

Data type

boolean

Alias
LOINC Version 232
MTHU020173
SNOMED CT 2011_0131
420970005
UMLS CUI [1,1]
C1563922
UMLS CUI [1,2]
C1720476
Pregnant or nursing patients
Description

Pregnant or nursing patients

Data type

boolean

Alias
UMLS CUI 1
C0549206
MedDRA 1
10036586
UMLS CUI 2
C0006147
MedDRA 2
10006247
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
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
161659007 (SNOMED CT 2011_0131)
261244009 (SNOMED CT 2011_0131)
105456007 (SNOMED CT 2011_0131)
C0455636 (UMLS CUI [1,1])
C0006629 (UMLS CUI [1,2])
C0348050 (UMLS CUI [1,3])
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
2603003 (SNOMED CT 2011_0131)
70536003 (SNOMED CT 2011_0131)
10038533 (MedDRA 14.1)
55.6 (ICD-9-CM Version 2011)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
E (HL7 V3 2006_05)
24486003 (SNOMED CT 2011_0131)
72627004 (SNOMED CT 2011_0131)
10044439 (MedDRA 14.1)
C0022671 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0175668 (UMLS CUI [1,3])
Panel-reactive antibody level
Item
PRA level <= 20%.
boolean
10058280 (MedDRA 14.1)
276625007 (SNOMED CT 2011_0131)
C1141951 (UMLS CUI [1])
AB0-compatible
Item
AB0-compatible
boolean
C0344389 (UMLS CUI 2011AA)
112143006 (SNOMED CT 2011_0131)
C1524057 (UMLS CUI 2011AA)
7883008 (SNOMED CT 2011_0131)
Crossmatch incompatible
Item
Negative crossmatch
boolean
10011412 (MedDRA 14.1)
C0855281 (UMLS CUI [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
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
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
Item
Incompatibility to study medication (allergy, intolerance, hypersensitivity)
boolean
902003 (SNOMED CT 2011_0131)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
OINT (HL7 V3 2006_05)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
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
C0086287 (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
Item
Primary focal-sclerosing glomerulonephritis and membranoproliferative glomerulonephritis as an underlying disease
boolean
87017008 (SNOMED CT 2011_0131)
13335004 (SNOMED CT 2011_0131)
80321008 (SNOMED CT 2011_0131)
10018370 (MedDRA 14.1)
C0017668 (UMLS CUI [1,1])
C0017662 (UMLS CUI [1,2])
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)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
Thrombopenia, leukopenia or neutropenia
Item
Thrombopenia < 70.000/mm3 or leukopenia < 2.500/mm3 or neutropenia < 1500/ mm3.
boolean
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)
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)
10029366 (MedDRA 14.1)
E12198 (CTCAE 1105E)
C0040034 (UMLS CUI [1,1])
C0023530 (UMLS CUI [1,2])
C0853697 (UMLS CUI [1,3])
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)
C4050412 (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)
Patient dependency
Item
Patients who possibly depend on the sponsor or the trial physician
boolean
110465008 (SNOMED CT 2011_0131)
309343006 (SNOMED CT 2011_0131)
MTHU010489 (LOINC Version 232)
PHYS (HL7 V3 2006_05)
C0011547 (UMLS CUI [1])
Patients with signs of drug abuse or alcohol abuse
Item
Patients with signs of drug abuse or alcohol abuse
boolean
C0237123 (UMLS CUI 2011AA)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
medicines with interactions with immune suppressive substances
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
MTHU013802 (LOINC Version 232)
372823004, 69431002 (SNOMED CT 2011_0131)
386976000 (SNOMED CT 2011_0131)
386975001 (SNOMED CT 2011_0131)
MTHU001849 (LOINC Version 232)
77765009 (SNOMED CT 2011_0131)
31509003 (SNOMED CT 2011_0131)
86553008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI [1,1])
C1704675 (UMLS CUI [1,2])
C0021081 (UMLS CUI [1,3])
Cold ischemia time of donor kidney
Item
Cold ischemia time of donor kidney > 30 hours
boolean
MTHU020173 (LOINC Version 232)
420970005 (SNOMED CT 2011_0131)
C1563922 (UMLS CUI [1,1])
C1720476 (UMLS CUI [1,2])
Pregnant or nursing patients
Item
Pregnant or nursing patients
boolean
C0549206 (UMLS CUI 1)
10036586 (MedDRA 1)
C0006147 (UMLS CUI 2)
10006247 (MedDRA 2)
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