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

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

Eligibility

  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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