ID

35853

Beschreibung

Study to Evaluate the Safety, Tolerability, Efficacy and PK of IdeS in Kidney Transplantation; ODM derived from: https://clinicaltrials.gov/show/NCT02475551

Link

https://clinicaltrials.gov/show/NCT02475551

Stichworte

Versionen (1)
  1. 27.03.19 27.03.19 -
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See clinicaltrials.gov

Hochgeladen am

27. März 2019

DOI

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Eligibility End Stage Kidney Disease NCT02475551

Englisch

Eligibility End Stage Kidney Disease NCT02475551

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients diagnosed with ckd and in dialysis with preformed anti-hla antibodies (non-dsa, dsa or both), negative t-cdc cxm and at least one antibody mfi > 3000
Beschreibung

Chronic Kidney Disease | Dialysis procedure | Human leukocyte antigen antibody | Other Coding | Donor specific antibody present | T-Lymphocyte Complement dependent cytotoxicity Crossmatch Negative | Antibody Median Fluorescence Intensity Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C1561643
UMLS CUI [2]
C0011946
UMLS CUI [3]
C1370147
UMLS CUI [4]
C3846158
UMLS CUI [5]
C3888632
UMLS CUI [6,1]
C0039194
UMLS CUI [6,2]
C4084772
UMLS CUI [6,3]
C0855279
UMLS CUI [6,4]
C1513916
UMLS CUI [7,1]
C0003241
UMLS CUI [7,2]
C3272964
UMLS CUI [7,3]
C1265611
Exclusion Criteria
Beschreibung

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.
Beschreibung

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

Datentyp

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
Beschreibung

Serum Hepatitis B Surface Antigen Test Positive | Hepatitis C antibody positive | HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1254699
UMLS CUI [1,2]
C1514241
UMLS CUI [2]
C0281863
UMLS CUI [3]
C0019699
clinical signs of ongoing infectious disease.
Beschreibung

Sign or Symptom Communicable Disease

Datentyp

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)
Beschreibung

Condition Severe Treatment required for | Condition Severe Requirement Monitoring | Heart failure New York Heart Association Classification | Coronary heart disease Unstable | Chronic Obstructive Airway Disease Dependence on supplemental oxygen

Datentyp

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]
C1283169
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C1275491
UMLS CUI [4,1]
C0010068
UMLS CUI [4,2]
C0443343
UMLS CUI [5,1]
C0024117
UMLS CUI [5,2]
C1135276
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
Beschreibung

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

Datentyp

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
Beschreibung

Hypogammaglobulinemia | Immunoglobulin G measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0086438
UMLS CUI [2]
C0202087
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)
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1564954
UMLS CUI [1,4]
C2348205
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C1564954
UMLS CUI [2,4]
C2348205
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0038418
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
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.
Beschreibung

Investigational New Drugs | Study Subject Participation Status | Pharmacotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2348568
UMLS CUI [3]
C0013216
patients consented and screened but not dosed in previous studies are not excluded
Beschreibung

Study Subject Participation Status | Dosage Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0332197
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Ähnliche Modelle

Eligibility End Stage Kidney Disease NCT02475551

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Kidney Disease | Dialysis procedure | Human leukocyte antigen antibody | Other Coding | Donor specific antibody present | T-Lymphocyte Complement dependent cytotoxicity Crossmatch Negative | Antibody Median Fluorescence Intensity Quantity
Item
patients diagnosed with ckd and in dialysis with preformed anti-hla antibodies (non-dsa, dsa or both), negative t-cdc cxm and at least one antibody mfi > 3000
boolean
C1561643 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
C1370147 (UMLS CUI [3])
C3846158 (UMLS CUI [4])
C3888632 (UMLS CUI [5])
C0039194 (UMLS CUI [6,1])
C4084772 (UMLS CUI [6,2])
C0855279 (UMLS CUI [6,3])
C1513916 (UMLS CUI [6,4])
C0003241 (UMLS CUI [7,1])
C3272964 (UMLS CUI [7,2])
C1265611 (UMLS CUI [7,3])
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])
Serum Hepatitis B Surface Antigen Test 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
C1254699 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
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 heart disease Unstable | Chronic Obstructive Airway Disease Dependence on supplemental oxygen
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])
C1283169 (UMLS CUI [2,4])
C0018801 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0010068 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0024117 (UMLS CUI [5,1])
C1135276 (UMLS CUI [5,2])
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 | Immunoglobulin G measurement
Item
hypogammaglobulinemia defined as any values of p-total igg less than 3 g/l
boolean
C0086438 (UMLS CUI [1])
C0202087 (UMLS CUI [2])
Severe allergy Pharmaceutical Preparations IdeS Similar | Hypersensitivity Pharmaceutical Preparations IdeS Similar | Hypersensitivity Streptokinase | 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 [1,1])
C0013227 (UMLS CUI [1,2])
C1564954 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C1564954 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
C0020517 (UMLS CUI [3,1])
C0038418 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0143595 (UMLS CUI [4,2])
Investigational New Drugs | Study Subject Participation Status | Pharmacotherapy
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.
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C0013216 (UMLS CUI [3])
Study Subject Participation Status | Dosage Absent
Item
patients consented and screened but not dosed in previous studies are not excluded
boolean
C2348568 (UMLS CUI [1])
C0178602 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
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