ID

27942

Descripción

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

Palabras clave

  1. 6/12/17 6/12/17 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

6 de diciembre de 2017

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Chronic Kidney Disease NCT00632125

Eligibility Chronic Kidney Disease NCT00632125

Inclusion Criteria
Descripción

Inclusion Criteria

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

Chronic Kidney Disease | Dialysis

Tipo de datos

boolean

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

Age

Tipo de datos

boolean

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

Erythropoiesis-stimulating Agent Intravenous Patient need for

Tipo de datos

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
Descripción

ESA Intravenous Remaining Probably

Tipo de datos

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 -
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

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

Immunosuppressive Agents Systemic | Pharmaceutical Preparations Adverse effects Hemoglobin level

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Pure Red-Cell Aplasia | Aplastic Anemia

Tipo de datos

boolean

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

Anti-erythropoietin antibody

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1328371
uncontrolled hypertension
Descripción

Uncontrolled hypertension

Tipo de datos

boolean

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

Pregnancy | Breast Feeding

Tipo de datos

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.
Descripción

Childbearing Potential Contraceptive methods Unwilling

Tipo de datos

boolean

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

Similar models

Eligibility Chronic Kidney Disease NCT00632125

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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