ID

27942

Description

Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v.; ODM derived from: https://clinicaltrials.gov/show/NCT00632125

Link

https://clinicaltrials.gov/show/NCT00632125

Keywords

Versions (1)
  1. 12/6/17 12/6/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 6, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Kidney Disease NCT00632125

English

Eligibility Chronic Kidney Disease NCT00632125

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
ckd subjects with or without dialysis treatment
Description

Chronic Kidney Disease | Dialysis

Data type

boolean

Alias
UMLS CUI [1]
C1561643
UMLS CUI [2]
C0011946
age over 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subjects requiring i.v. esa treatment
Description

Erythropoiesis-stimulating Agent Intravenous Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C2917382
UMLS CUI [1,2]
C1522726
UMLS CUI [1,3]
C0686904
subjects likely to remain on i.v. esa treatment for 6 months
Description

ESA Intravenous Remaining Probably

Data type

boolean

Alias
UMLS CUI [1,1]
C2917382
UMLS CUI [1,2]
C1522726
UMLS CUI [1,3]
C1527428
UMLS CUI [1,4]
C0750492
provision of informed consent -
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
systemic immunosuppressive medication or any other drugs known to adversely affect the hemoglobin level
Description

Immunosuppressive Agents Systemic | Pharmaceutical Preparations Adverse effects Hemoglobin level

Data type

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0879626
UMLS CUI [2,3]
C0019029
known primary lack of efficacy (loe), unexplained loss of effect to a recombinant erythropoietin product
Description

Recombinant Erythropoietin Lack of Efficacy Primary | Recombinant Erythropoietin Loss Effect Unknown

Data type

boolean

Alias
UMLS CUI [1,1]
C0376541
UMLS CUI [1,2]
C0235828
UMLS CUI [1,3]
C0205225
UMLS CUI [2,1]
C0376541
UMLS CUI [2,2]
C1517945
UMLS CUI [2,3]
C1280500
UMLS CUI [2,4]
C0439673
history of prca or aplastic anemia
Description

Pure Red-Cell Aplasia | Aplastic Anemia

Data type

boolean

Alias
UMLS CUI [1]
C0034902
UMLS CUI [2]
C0002874
history of anti-erythropoietin antibodies
Description

Anti-erythropoietin antibody

Data type

boolean

Alias
UMLS CUI [1]
C1328371
uncontrolled hypertension
Description

Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885
pregnant woman or nursing mother
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of childbearing potential do not agree to maintain effective birth control during the study treatment period.
Description

Childbearing Potential Contraceptive methods Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
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Similar models

Eligibility Chronic Kidney Disease NCT00632125

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Kidney Disease | Dialysis
Item
ckd subjects with or without dialysis treatment
boolean
C1561643 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
Age
Item
age over 18 years
boolean
C0001779 (UMLS CUI [1])
Erythropoiesis-stimulating Agent Intravenous Patient need for
Item
subjects requiring i.v. esa treatment
boolean
C2917382 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
ESA Intravenous Remaining Probably
Item
subjects likely to remain on i.v. esa treatment for 6 months
boolean
C2917382 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C1527428 (UMLS CUI [1,3])
C0750492 (UMLS CUI [1,4])
Informed Consent
Item
provision of informed consent -
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Immunosuppressive Agents Systemic | Pharmaceutical Preparations Adverse effects Hemoglobin level
Item
systemic immunosuppressive medication or any other drugs known to adversely affect the hemoglobin level
boolean
C0021081 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0879626 (UMLS CUI [2,2])
C0019029 (UMLS CUI [2,3])
Recombinant Erythropoietin Lack of Efficacy Primary | Recombinant Erythropoietin Loss Effect Unknown
Item
known primary lack of efficacy (loe), unexplained loss of effect to a recombinant erythropoietin product
boolean
C0376541 (UMLS CUI [1,1])
C0235828 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0376541 (UMLS CUI [2,1])
C1517945 (UMLS CUI [2,2])
C1280500 (UMLS CUI [2,3])
C0439673 (UMLS CUI [2,4])
Pure Red-Cell Aplasia | Aplastic Anemia
Item
history of prca or aplastic anemia
boolean
C0034902 (UMLS CUI [1])
C0002874 (UMLS CUI [2])
Anti-erythropoietin antibody
Item
history of anti-erythropoietin antibodies
boolean
C1328371 (UMLS CUI [1])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant woman or nursing mother
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Unwilling
Item
women of childbearing potential do not agree to maintain effective birth control during the study treatment period.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
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