Eligibility DRKS00006521 NCT00554502 IGA Nephropathy
ODM derived from http://clinicaltrials.gov/show/NCT00554502

Eligibility

  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
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0015780 (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)
C1737225 (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)
C1554196 (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)
C0341697 (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)
C0439831 (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)