ID

35299

Beskrivning

Phase II Study to Evaluate Safety and Efficacy of Intravenous Immunoglobulin G Degrading Enzyme of Streptococcus Pyogenes (IdeS) in Chronic Kidney Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02224820

Länk

https://clinicaltrials.gov/show/NCT02224820

Nyckelord

Versioner (1)
  1. 2019-02-26 2019-02-26 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

26 februari 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Chronic Kidney Disease NCT02224820

Engelsk

Eligibility Chronic Kidney Disease NCT02224820

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with chronic kidney disease and in dialysis with identified antibodies against at least two hla antigens of which at least one is 3000 mfi or more as measured by sab assay on at least two occasions.
Beskrivning

Chronic Kidney Disease | Dialysis | HLA antibody identification | Single Antigen Bead-based Multiplex Assay

Datatyp

boolean

Alias
UMLS CUI [1]
C1561643
UMLS CUI [2]
C0011946
UMLS CUI [3]
C3508207
UMLS CUI [4]
C4331290
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior malignancy within 2 years excluding adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ and prostate cancer gleason <6 and prostate-specific antigen (psa) <10 ng/ml.
Beskrivning

Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix | Exception Prostate carcinoma Gleason score | Exception Prostate carcinoma Prostate specific antigen measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0600139
UMLS CUI [5,3]
C3203027
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0600139
UMLS CUI [6,3]
C0201544
any positive result on screening for serum hepatitis b surface antigen, hepatitis c antibody and human immunodeficiency virus (hiv
Beskrivning

Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0281863
UMLS CUI [3]
C0019699
clinical signs of ongoing infectious disease.
Beskrivning

Sign or Symptom Communicable Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0009450
severe other conditions requiring treatment and close monitoring, e.g. cardiac failure > new york heart association (nyha) grade 3, unstable coronary disease or oxygen dependent chronic obstructive pulmonary disease (copd)
Beskrivning

Condition Severe Treatment required for | Condition Severe Requirement Monitoring | Heart failure New York Heart Association Classification | Coronary Disease Unstable | Chronic Obstructive Airway Disease Oxygen Dependence

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332121
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C0026429
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C1275491
UMLS CUI [4,1]
C1956346
UMLS CUI [4,2]
C0443343
UMLS CUI [5,1]
C0024117
UMLS CUI [5,2]
C0030054
UMLS CUI [5,3]
C0439857
history of any other clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at increased risk because of participation in the study, or influence the results or the patient's ability to participate in the study
Beskrivning

Disease Study Subject Participation Status At risk | Disease Influence Research results | Disease Influence Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C4054723
UMLS CUI [2,3]
C0683954
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C4054723
UMLS CUI [3,3]
C2348568
hypogammaglobulinemia defined as any values of p-total igg less than 3 g/l
Beskrivning

Hypogammaglobulinemia | Total Serum IgG Test

Datatyp

boolean

Alias
UMLS CUI [1]
C0086438
UMLS CUI [2]
C1254650
history of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to ides (e. g streptokinase and/or staphylokinase)
Beskrivning

Severe allergy | Hypersensitivity | Hypersensitivity Pharmaceutical Preparations IdeS protein Similar | Streptokinase allergy | Hypersensitivity Staphylokinase

Datatyp

boolean

Alias
UMLS CUI [1]
C2945656
UMLS CUI [2]
C0020517
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C1564954
UMLS CUI [3,4]
C2348205
UMLS CUI [4]
C0572009
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0143595
has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 4 months of the first administration of investigational product in this study. patients consented and screened but not dosed in previous studies are not excluded
Beskrivning

Compound Investigational | Study Subject Participation Status | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1706082
UMLS CUI [1,2]
C1517586
UMLS CUI [2]
C2348568
UMLS CUI [3]
C0013230
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Similar models

Eligibility Chronic Kidney Disease NCT02224820

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Kidney Disease | Dialysis | HLA antibody identification | Single Antigen Bead-based Multiplex Assay
Item
diagnosed with chronic kidney disease and in dialysis with identified antibodies against at least two hla antigens of which at least one is 3000 mfi or more as measured by sab assay on at least two occasions.
boolean
C1561643 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
C3508207 (UMLS CUI [3])
C4331290 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix | Exception Prostate carcinoma Gleason score | Exception Prostate carcinoma Prostate specific antigen measurement
Item
prior malignancy within 2 years excluding adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ and prostate cancer gleason <6 and prostate-specific antigen (psa) <10 ng/ml.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0600139 (UMLS CUI [5,2])
C3203027 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0600139 (UMLS CUI [6,2])
C0201544 (UMLS CUI [6,3])
Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV Seropositivity
Item
any positive result on screening for serum hepatitis b surface antigen, hepatitis c antibody and human immunodeficiency virus (hiv
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Sign or Symptom Communicable Disease
Item
clinical signs of ongoing infectious disease.
boolean
C3540840 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
Condition Severe Treatment required for | Condition Severe Requirement Monitoring | Heart failure New York Heart Association Classification | Coronary Disease Unstable | Chronic Obstructive Airway Disease Oxygen Dependence
Item
severe other conditions requiring treatment and close monitoring, e.g. cardiac failure > new york heart association (nyha) grade 3, unstable coronary disease or oxygen dependent chronic obstructive pulmonary disease (copd)
boolean
C0348080 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C0026429 (UMLS CUI [2,4])
C0018801 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C1956346 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0024117 (UMLS CUI [5,1])
C0030054 (UMLS CUI [5,2])
C0439857 (UMLS CUI [5,3])
Disease Study Subject Participation Status At risk | Disease Influence Research results | Disease Influence Study Subject Participation Status
Item
history of any other clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at increased risk because of participation in the study, or influence the results or the patient's ability to participate in the study
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C4054723 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
Hypogammaglobulinemia | Total Serum IgG Test
Item
hypogammaglobulinemia defined as any values of p-total igg less than 3 g/l
boolean
C0086438 (UMLS CUI [1])
C1254650 (UMLS CUI [2])
Severe allergy | Hypersensitivity | Hypersensitivity Pharmaceutical Preparations IdeS protein Similar | Streptokinase allergy | Hypersensitivity Staphylokinase
Item
history of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to ides (e. g streptokinase and/or staphylokinase)
boolean
C2945656 (UMLS CUI [1])
C0020517 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C1564954 (UMLS CUI [3,3])
C2348205 (UMLS CUI [3,4])
C0572009 (UMLS CUI [4])
C0020517 (UMLS CUI [5,1])
C0143595 (UMLS CUI [5,2])
Compound Investigational | Study Subject Participation Status | Investigational New Drugs
Item
has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 4 months of the first administration of investigational product in this study. patients consented and screened but not dosed in previous studies are not excluded
boolean
C1706082 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
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