ID

43384

Description

ODM derived from http://clinicaltrials.gov/show/NCT00554502

Link

http://clinicaltrials.gov/show/NCT00554502

Keywords

Versions (4)
  1. 12/10/13 12/10/13 - Martin Dugas
  2. 4/15/14 4/15/14 - Julian Varghese
  3. 4/15/14 4/15/14 - Julian Varghese
  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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Eligibility DRKS00006521 NCT00554502 IGA Nephropathy

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 70 Years
Description

age 18 Years to 70 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Male or female patients from 18-70 years with histologically proven primary IgAN with typical mesangioproliferative features. Diagnosis has to be made by a neuropathologist.
Description

Male or female patients from 18-70 years with histologically proven primary IgAN with typical mesangioproliferative features. Diagnosis has to be made by a neuropathologist.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0456369
SNOMED CT 2011_0131
277025001
UMLS CUI 2011AA
C0017661
SNOMED CT 2011_0131
236407003, 68779003
MedDRA 14.1
10069341
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0221238
MedDRA 14.1
10066453
UMLS CUI 2011AA
C0334866
SNOMED CT 2011_0131
61207006
LOINC Version 232
MTHU008856
HL7 V3 2006_05
207Z00000X
Proteinuria above 0.75 g/day within 12 weeks prior to or at the first visit in the run-in phase (month -6)and presence of at least one further risk factor for the development of end stage renal disease 1. arterial hypertension, defined as ambulatory blood pressure >140/90 mm Hg or the use of antihypertensive medication or 2. impaired renal function, defined as creatinine clearance or estimated GFR <90 ml/min.
Description

Proteinuria above 0.75 g/day within 12 weeks prior to or at the first visit in the run-in phase (month -6)and presence of at least one further risk factor for the development of end stage renal disease 1. arterial hypertension, defined as ambulatory blood pressure >140/90 mm Hg or the use of antihypertensive medication or 2. impaired renal function, defined as creatinine clearance or estimated GFR <90 ml/min.

Data type

boolean

Alias
UMLS CUI 2011AA
C0033687
SNOMED CT 2011_0131
29738008
MedDRA 14.1
10037032
ICD-10-CM Version 2010
R80
ICD-9-CM Version 2011
791.0
CTCAE 1105E
E13008
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0205435
SNOMED CT 2011_0131
255216001
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
CL432972
UMLS CUI 2011AA
C2825407
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0035648
SNOMED CT 2011_0131
80943009
LOINC Version 232
MTHU028018
UMLS CUI 2011AA
C1261469
SNOMED CT 2011_0131
46177005
ICD-9-CM Version 2011
585.6
UMLS CUI 2011AA
C0020538
SNOMED CT 2011_0131
38341003
MedDRA 14.1
10020772
LOINC Version 232
MTHU020789
ICD-10-CM Version 2010
I10
ICD-9-CM Version 2011
997.91
CTCAE 1105E
E13785
UMLS CUI 2011AA
C0264648
SNOMED CT 2011_0131
39018007
UMLS CUI 2011AA
C0430452
SNOMED CT 2011_0131
164783007
UMLS CUI 2011AA
C0003364
SNOMED CT 2011_0131
372586001
UMLS CUI 2011AA
C1565489
SNOMED CT 2011_0131
236423003
MedDRA 14.1
10062237
UMLS CUI 2011AA
C0373595
SNOMED CT 2011_0131
167181009
MedDRA 14.1
10011371
UMLS CUI 2011AA
C0750572
SNOMED CT 2011_0131
414135002
UMLS CUI 2011AA
C0017654
SNOMED CT 2011_0131
80274001
MedDRA 14.1
10018355
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Known allergy or intolerance to study medication (except in case of ACE-inhibitor, in which case a change to an angiotensin receptor blocker is possible).
Description

Known allergy or intolerance to study medication (except in case of ACE-inhibitor, in which case a change to an angiotensin receptor blocker is possible).

Data type

boolean

Alias
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
CL415164
HL7 V3 2006_05
OINT
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0003015
SNOMED CT 2011_0131
372733002
UMLS CUI 2011AA
C0815017
Women who are pregnant or breastfeeding and women without sufficient contraception.
Description

Women who are pregnant or breastfeeding and women without sufficient contraception.

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Any prior immunosuppressive therapy.
Description

Any prior immunosuppressive therapy.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0021079
SNOMED CT 2011_0131
86553008
Variants of primary IgAN (e.g. rapidly progressive IgAN with crescents in >50% of glomeruli or minimal change GN with glomerular IgA deposits).
Description

Variants of primary IgAN (e.g. rapidly progressive IgAN with crescents in >50% of glomeruli or minimal change GN with glomerular IgA deposits).

Data type

boolean

Alias
UMLS CUI 2011AA
C0205419
SNOMED CT 2011_0131
40885006
UMLS CUI 2011AA
C0017661
SNOMED CT 2011_0131
236407003, 68779003
MedDRA 14.1
10069341
UMLS CUI 2011AA
C0456962
SNOMED CT 2011_0131
255358001
UMLS CUI 2011AA
C0205329
SNOMED CT 2011_0131
255314001
UMLS CUI 2011AA
C0017661
SNOMED CT 2011_0131
236407003, 68779003
MedDRA 14.1
10069341
UMLS CUI 2011AA
C0444628
SNOMED CT 2011_0131
264296008
UMLS CUI 2011AA
C0022663
SNOMED CT 2011_0131
68288006
UMLS CUI 2011AA
C1704320
MedDRA 14.1
10018374
UMLS CUI 2011AA
C0022663
SNOMED CT 2011_0131
68288006
UMLS CUI 2011AA
C2959644
SNOMED CT 2011_0131
446944008
Significant liver dysfunction (more than three fold increased GPT compared to norm)
Description

Significant liver dysfunction (more than three fold increased GPT compared to norm)

Data type

boolean

Alias
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0086565
SNOMED CT 2011_0131
75183008
MedDRA 14.1
10019670
UMLS CUI 2011AA
C0151905
MedDRA 14.1
10018644
CTCAE 1105E
E12077
Contraindication for immunosuppressive therapy, like
Description

Contraindication for immunosuppressive therapy, like

Data type

boolean

Alias
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C0021079
SNOMED CT 2011_0131
86553008
acute or chronic infectious disease incl. hepatitis and HIV positive patients
Description

acute or chronic infectious disease incl. hepatitis and HIV positive patients

Data type

boolean

Alias
UMLS CUI 2011AA
C0275518
SNOMED CT 2011_0131
63171007
UMLS CUI 2011AA
C0151317
SNOMED CT 2011_0131
177010002
UMLS CUI 2011AA
C0019158
SNOMED CT 2011_0131
29001004
MedDRA 14.1
10019717
UMLS CUI 2011AA
C0019699
SNOMED CT 2011_0131
165816005
MedDRA 14.1
10020188
ICD-10-CM Version 2010
Z21
Malignant Neoplasms
Description

any malignancy

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
leukocytopenia, thrombocytopenia or known allergy against prednisolone, cyclophosphamide or azathioprine
Description

leukocytopenia, thrombocytopenia or known allergy against prednisolone, cyclophosphamide or azathioprine

Data type

boolean

Alias
UMLS CUI 2011AA
C0023530
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
UMLS CUI 2011AA
C0040034
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
UMLS CUI 2011AA
C0205309
SNOMED CT 2011_0131
36692007
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0032950
SNOMED CT 2011_0131
116601002
LOINC Version 232
MTHU003522
UMLS CUI 2011AA
C0010583
SNOMED CT 2011_0131
387420009
LOINC Version 232
MTHU029970
UMLS CUI 2011AA
C0004482
SNOMED CT 2011_0131
372574004
LOINC Version 232
MTHU006794
active intestinal bleeding, active gastric or duodenal ulcer
Description

active intestinal bleeding, active gastric or duodenal ulcer

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0267373
MedDRA 14.1
10059175
ICD-10-CM Version 2010
K92.2
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0038358
SNOMED CT 2011_0131
397825006
MedDRA 14.1
10017822
ICD-10-CM Version 2010
K25
ICD-9-CM Version 2011
531
CTCAE 1105E
E10727
UMLS CUI 2011AA
C0013295
SNOMED CT 2011_0131
367474008
MedDRA 14.1
10013836
ICD-10-CM Version 2010
K26
ICD-9-CM Version 2011
532
CTCAE 1105E
E10611
Need of permanent immunosuppression, (e.g. transplanted patients, steroid-dependent inflammatory diseases)
Description

Need of permanent immunosuppression, (e.g. transplanted patients, steroid-dependent inflammatory diseases)

Data type

boolean

Alias
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0205355
SNOMED CT 2011_0131
6934004
UMLS CUI 2011AA
C0021079
SNOMED CT 2011_0131
86553008
UMLS CUI 2011AA
C0040732
SNOMED CT 2011_0131
77465005
MedDRA 14.1
10057677
UMLS CUI 2011AA
C0038317
SNOMED CT 2011_0131
116566001
UMLS CUI 2011AA
CL414916
UMLS CUI 2011AA
C1290884
SNOMED CT 2011_0131
128139000
Secondary IgAN or diseases associated with glomerular deposits of IgA.
Description

Secondary IgAN or diseases associated with glomerular deposits of IgA.

Data type

boolean

Alias
UMLS CUI 2011AA
C0175668
SNOMED CT 2011_0131
2603003
UMLS CUI 2011AA
C0017661
SNOMED CT 2011_0131
236407003, 68779003
MedDRA 14.1
10069341
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0332281
SNOMED CT 2011_0131
47429007
UMLS CUI 2011AA
C0022663
SNOMED CT 2011_0131
68288006
UMLS CUI 2011AA
C2959644
SNOMED CT 2011_0131
446944008
Additional other chronic renal disease.
Description

Additional other chronic renal disease.

Data type

boolean

Alias
UMLS CUI 2011AA
C1524062
LOINC Version 232
MTHU013802
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0022661
SNOMED CT 2011_0131
90688005
MedDRA 14.1
10038444
ICD-10-CM Version 2010
N18.9
ICD-9-CM Version 2011
585.6
Creatinine clearance below 30 ml/min (mean of 3 measurements).
Description

Creatinine clearance below 30 ml/min (mean of 3 measurements).

Data type

boolean

Alias
UMLS CUI 2011AA
C0373595
SNOMED CT 2011_0131
167181009
MedDRA 14.1
10011371
UMLS CUI 2011AA
CL384716
UMLS CUI 2011AA
C0444504
SNOMED CT 2011_0131
255586005
UMLS CUI 2011AA
C0242485
SNOMED CT 2011_0131
122869004
LOINC Version 232
MTHU003137
Alcohol or drug abuse
Description

Alcohol or drug abuse

Data type

boolean

Alias
UMLS CUI 2011AA
C0237123
Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
Description

Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study

Data type

boolean

Alias
UMLS CUI 2011AA
C0278060
SNOMED CT 2011_0131
36456004
LOINC Version 232
MTHU001424
CTCAE 1105E
MTHU117157
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C0162340
SNOMED CT 2011_0131
66216009
UMLS CUI 2011AA
C1710028
UMLS CUI 2011AA
C0686907
SNOMED CT 2011_0131
103332005
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
Description

Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study

Data type

boolean

Alias
UMLS CUI 2011AA
C1321605
Participation in a parallel clinical trial or participation in another clinical trial within the last 3 months.
Description

Participation in a parallel clinical trial or participation in another clinical trial within the last 3 months.

Data type

boolean

Alias
UMLS CUI 2011AA
C0679823
UMLS CUI 2011AA
C2826345
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
Subjects who are in any state of dependency to the sponsor or the investigators.
Description

Subjects who are in any state of dependency to the sponsor or the investigators.

Data type

boolean

Alias
UMLS CUI 2011AA
CL414916
UMLS CUI 2011AA
C2347796
UMLS CUI 2011AA
CL102947
Employees of the sponsor or the investigators.
Description

Employees of the sponsor or the investigators.

Data type

boolean

Alias
UMLS CUI 2011AA
C0599987
SNOMED CT 2011_0131
224528001
UMLS CUI 2011AA
C2347796
UMLS CUI 2011AA
CL102947
Subjects who have been committed to an institution by legal or regulatory order.
Description

Subjects who have been committed to an institution by legal or regulatory order.

Data type

boolean

Alias
UMLS CUI 2011AA
C0699792
SNOMED CT 2011_0131
263498003
UMLS CUI 2011AA
C0021622
UMLS CUI 2011AA
C1301860
SNOMED CT 2011_0131
398165009
UMLS CUI 2011AA
C1704735
UMLS CUI 2011AA
C1705178
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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
CL425202 (UMLS CUI 2011AA)
age 18 Years to 70 Years
Item
age 18 Years to 70 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Male or female patients from 18-70 years with histologically proven primary IgAN with typical mesangioproliferative features. Diagnosis has to be made by a neuropathologist.
Item
Male or female patients from 18-70 years with histologically proven primary IgAN with typical mesangioproliferative features. Diagnosis has to be made by a neuropathologist.
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0456369 (UMLS CUI 2011AA)
277025001 (SNOMED CT 2011_0131)
C0017661 (UMLS CUI 2011AA)
236407003, 68779003 (SNOMED CT 2011_0131)
10069341 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0221238 (UMLS CUI 2011AA)
10066453 (MedDRA 14.1)
C0334866 (UMLS CUI 2011AA)
61207006 (SNOMED CT 2011_0131)
MTHU008856 (LOINC Version 232)
207Z00000X (HL7 V3 2006_05)
Proteinuria above 0.75 g/day within 12 weeks prior to or at the first visit in the run-in phase (month -6)and presence of at least one further risk factor for the development of end stage renal disease 1. arterial hypertension, defined as ambulatory blood pressure >140/90 mm Hg or the use of antihypertensive medication or 2. impaired renal function, defined as creatinine clearance or estimated GFR <90 ml/min.
Item
Proteinuria above 0.75 g/day within 12 weeks prior to or at the first visit in the run-in phase (month -6)and presence of at least one further risk factor for the development of end stage renal disease 1. arterial hypertension, defined as ambulatory blood pressure >140/90 mm Hg or the use of antihypertensive medication or 2. impaired renal function, defined as creatinine clearance or estimated GFR <90 ml/min.
boolean
C0033687 (UMLS CUI 2011AA)
29738008 (SNOMED CT 2011_0131)
10037032 (MedDRA 14.1)
R80 (ICD-10-CM Version 2010)
791.0 (ICD-9-CM Version 2011)
E13008 (CTCAE 1105E)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0205435 (UMLS CUI 2011AA)
255216001 (SNOMED CT 2011_0131)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
CL432972 (UMLS CUI 2011AA)
C2825407 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0035648 (UMLS CUI 2011AA)
80943009 (SNOMED CT 2011_0131)
MTHU028018 (LOINC Version 232)
C1261469 (UMLS CUI 2011AA)
46177005 (SNOMED CT 2011_0131)
585.6 (ICD-9-CM Version 2011)
C0020538 (UMLS CUI 2011AA)
38341003 (SNOMED CT 2011_0131)
10020772 (MedDRA 14.1)
MTHU020789 (LOINC Version 232)
I10 (ICD-10-CM Version 2010)
997.91 (ICD-9-CM Version 2011)
E13785 (CTCAE 1105E)
C0264648 (UMLS CUI 2011AA)
39018007 (SNOMED CT 2011_0131)
C0430452 (UMLS CUI 2011AA)
164783007 (SNOMED CT 2011_0131)
C0003364 (UMLS CUI 2011AA)
372586001 (SNOMED CT 2011_0131)
C1565489 (UMLS CUI 2011AA)
236423003 (SNOMED CT 2011_0131)
10062237 (MedDRA 14.1)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
C0750572 (UMLS CUI 2011AA)
414135002 (SNOMED CT 2011_0131)
C0017654 (UMLS CUI 2011AA)
80274001 (SNOMED CT 2011_0131)
10018355 (MedDRA 14.1)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Known allergy or intolerance to study medication (except in case of ACE-inhibitor, in which case a change to an angiotensin receptor blocker is possible).
Item
Known allergy or intolerance to study medication (except in case of ACE-inhibitor, in which case a change to an angiotensin receptor blocker is possible).
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (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)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0003015 (UMLS CUI 2011AA)
372733002 (SNOMED CT 2011_0131)
C0815017 (UMLS CUI 2011AA)
Women who are pregnant or breastfeeding and women without sufficient contraception.
Item
Women who are pregnant or breastfeeding and women without sufficient contraception.
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Any prior immunosuppressive therapy.
Item
Any prior immunosuppressive therapy.
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)
Variants of primary IgAN (e.g. rapidly progressive IgAN with crescents in >50% of glomeruli or minimal change GN with glomerular IgA deposits).
Item
Variants of primary IgAN (e.g. rapidly progressive IgAN with crescents in >50% of glomeruli or minimal change GN with glomerular IgA deposits).
boolean
C0205419 (UMLS CUI 2011AA)
40885006 (SNOMED CT 2011_0131)
C0017661 (UMLS CUI 2011AA)
236407003, 68779003 (SNOMED CT 2011_0131)
10069341 (MedDRA 14.1)
C0456962 (UMLS CUI 2011AA)
255358001 (SNOMED CT 2011_0131)
C0205329 (UMLS CUI 2011AA)
255314001 (SNOMED CT 2011_0131)
C0017661 (UMLS CUI 2011AA)
236407003, 68779003 (SNOMED CT 2011_0131)
10069341 (MedDRA 14.1)
C0444628 (UMLS CUI 2011AA)
264296008 (SNOMED CT 2011_0131)
C0022663 (UMLS CUI 2011AA)
68288006 (SNOMED CT 2011_0131)
C1704320 (UMLS CUI 2011AA)
10018374 (MedDRA 14.1)
C0022663 (UMLS CUI 2011AA)
68288006 (SNOMED CT 2011_0131)
C2959644 (UMLS CUI 2011AA)
446944008 (SNOMED CT 2011_0131)
Significant liver dysfunction (more than three fold increased GPT compared to norm)
Item
Significant liver dysfunction (more than three fold increased GPT compared to norm)
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0086565 (UMLS CUI 2011AA)
75183008 (SNOMED CT 2011_0131)
10019670 (MedDRA 14.1)
C0151905 (UMLS CUI 2011AA)
10018644 (MedDRA 14.1)
E12077 (CTCAE 1105E)
Contraindication for immunosuppressive therapy, like
Item
Contraindication for immunosuppressive therapy, like
boolean
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)
acute or chronic infectious disease incl. hepatitis and HIV positive patients
Item
acute or chronic infectious disease incl. hepatitis and HIV positive patients
boolean
C0275518 (UMLS CUI 2011AA)
63171007 (SNOMED CT 2011_0131)
C0151317 (UMLS CUI 2011AA)
177010002 (SNOMED CT 2011_0131)
C0019158 (UMLS CUI 2011AA)
29001004 (SNOMED CT 2011_0131)
10019717 (MedDRA 14.1)
C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
any malignancy
Item
Malignant Neoplasms
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)
leukocytopenia, thrombocytopenia or known allergy against prednisolone, cyclophosphamide or azathioprine
Item
leukocytopenia, thrombocytopenia or known allergy against prednisolone, cyclophosphamide or azathioprine
boolean
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)
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)
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0032950 (UMLS CUI 2011AA)
116601002 (SNOMED CT 2011_0131)
MTHU003522 (LOINC Version 232)
C0010583 (UMLS CUI 2011AA)
387420009 (SNOMED CT 2011_0131)
MTHU029970 (LOINC Version 232)
C0004482 (UMLS CUI 2011AA)
372574004 (SNOMED CT 2011_0131)
MTHU006794 (LOINC Version 232)
active intestinal bleeding, active gastric or duodenal ulcer
Item
active intestinal bleeding, active gastric or duodenal ulcer
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0267373 (UMLS CUI 2011AA)
10059175 (MedDRA 14.1)
K92.2 (ICD-10-CM Version 2010)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0038358 (UMLS CUI 2011AA)
397825006 (SNOMED CT 2011_0131)
10017822 (MedDRA 14.1)
K25 (ICD-10-CM Version 2010)
531 (ICD-9-CM Version 2011)
E10727 (CTCAE 1105E)
C0013295 (UMLS CUI 2011AA)
367474008 (SNOMED CT 2011_0131)
10013836 (MedDRA 14.1)
K26 (ICD-10-CM Version 2010)
532 (ICD-9-CM Version 2011)
E10611 (CTCAE 1105E)
Need of permanent immunosuppression, (e.g. transplanted patients, steroid-dependent inflammatory diseases)
Item
Need of permanent immunosuppression, (e.g. transplanted patients, steroid-dependent inflammatory diseases)
boolean
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0205355 (UMLS CUI 2011AA)
6934004 (SNOMED CT 2011_0131)
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)
C0040732 (UMLS CUI 2011AA)
77465005 (SNOMED CT 2011_0131)
10057677 (MedDRA 14.1)
C0038317 (UMLS CUI 2011AA)
116566001 (SNOMED CT 2011_0131)
CL414916 (UMLS CUI 2011AA)
C1290884 (UMLS CUI 2011AA)
128139000 (SNOMED CT 2011_0131)
Secondary IgAN or diseases associated with glomerular deposits of IgA.
Item
Secondary IgAN or diseases associated with glomerular deposits of IgA.
boolean
C0175668 (UMLS CUI 2011AA)
2603003 (SNOMED CT 2011_0131)
C0017661 (UMLS CUI 2011AA)
236407003, 68779003 (SNOMED CT 2011_0131)
10069341 (MedDRA 14.1)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C0022663 (UMLS CUI 2011AA)
68288006 (SNOMED CT 2011_0131)
C2959644 (UMLS CUI 2011AA)
446944008 (SNOMED CT 2011_0131)
Additional other chronic renal disease.
Item
Additional other chronic renal disease.
boolean
C1524062 (UMLS CUI 2011AA)
MTHU013802 (LOINC Version 232)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0022661 (UMLS CUI 2011AA)
90688005 (SNOMED CT 2011_0131)
10038444 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
585.6 (ICD-9-CM Version 2011)
Creatinine clearance below 30 ml/min (mean of 3 measurements).
Item
Creatinine clearance below 30 ml/min (mean of 3 measurements).
boolean
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
CL384716 (UMLS CUI 2011AA)
C0444504 (UMLS CUI 2011AA)
255586005 (SNOMED CT 2011_0131)
C0242485 (UMLS CUI 2011AA)
122869004 (SNOMED CT 2011_0131)
MTHU003137 (LOINC Version 232)
Alcohol or drug abuse
Item
Alcohol or drug abuse
boolean
C0237123 (UMLS CUI 2011AA)
Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
Item
Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
boolean
C0278060 (UMLS CUI 2011AA)
36456004 (SNOMED CT 2011_0131)
MTHU001424 (LOINC Version 232)
MTHU117157 (CTCAE 1105E)
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0162340 (UMLS CUI 2011AA)
66216009 (SNOMED CT 2011_0131)
C1710028 (UMLS CUI 2011AA)
C0686907 (UMLS CUI 2011AA)
103332005 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
Item
Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
boolean
C1321605 (UMLS CUI 2011AA)
Participation in a parallel clinical trial or participation in another clinical trial within the last 3 months.
Item
Participation in a parallel clinical trial or participation in another clinical trial within the last 3 months.
boolean
C0679823 (UMLS CUI 2011AA)
C2826345 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Subjects who are in any state of dependency to the sponsor or the investigators.
Item
Subjects who are in any state of dependency to the sponsor or the investigators.
boolean
CL414916 (UMLS CUI 2011AA)
C2347796 (UMLS CUI 2011AA)
CL102947 (UMLS CUI 2011AA)
Employees of the sponsor or the investigators.
Item
Employees of the sponsor or the investigators.
boolean
C0599987 (UMLS CUI 2011AA)
224528001 (SNOMED CT 2011_0131)
C2347796 (UMLS CUI 2011AA)
CL102947 (UMLS CUI 2011AA)
Subjects who have been committed to an institution by legal or regulatory order.
Item
Subjects who have been committed to an institution by legal or regulatory order.
boolean
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
C0021622 (UMLS CUI 2011AA)
C1301860 (UMLS CUI 2011AA)
398165009 (SNOMED CT 2011_0131)
C1704735 (UMLS CUI 2011AA)
C1705178 (UMLS CUI 2011AA)
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