ID

14182

Description

Urinary Biomarkers of the Progression of Alport Kidney Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01705132

Link

https://clinicaltrials.gov/show/NCT01705132

Keywords

Versions (1)
  1. 4/3/16 4/3/16 -
Uploaded on

April 3, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Alport Syndrome NCT01705132

English

Eligibility Alport Syndrome NCT01705132

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects eligible for inclusion in this study have to fulfill all of the following criteria:
Description

Inclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C1512693
1. able to understand and comply with the requirements of the study and able to provide written informed consent.
Description

informed consent; compliance

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C1321605
2. male and female subjects ≥ 5 years of age.
Description

gender; age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
3. physically able to provide a single first-morning urine sample of at least 30 ml (one ounce).
Description

morning urine sample

Data type

boolean

Alias
UMLS CUI [1]
C0439057
4. alport syndrome diagnosis: clinical and/or histopathologic and/or genetic diagnosis of alport syndrome, as per the subject's physician and/or genotyping.
Description

alport syndrome; genotyping

Data type

boolean

Alias
UMLS CUI [1]
C1567741
UMLS CUI [2]
C1285573
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects fulfilling any of the following criteria are not eligible for inclusion in this study:
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
1. use of investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
Description

investigational drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0008972
2. chronic kidney disease, defined as a known diagnosis of ckd, and/or receiving chronic phosphate-lowering therapy or erythropoietin therapy.
Description

chronic kidney disease; erythropoietin therapy

Data type

boolean

Alias
UMLS CUI [1]
C1561643
UMLS CUI [2]
C0199970
3. ongoing chronic hemodialysis therapy and/or renal transplant recipient.
Description

Hemodialysis; renal transplant

Data type

boolean

Alias
UMLS CUI [1]
C0019004
UMLS CUI [2]
C0022671
4. nephrotic-range proteinuria: spot urine protein-to-creatinine ratio ≥ 3 on at least 2 of the last 3 clinical assessments.
Description

Nephrotic range proteinuria; spot urine protein-to-creatinine ratio

Data type

boolean

Alias
UMLS CUI [1]
C0445118
UMLS CUI [2,1]
C0457208
UMLS CUI [2,2]
C1096054
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Similar models

Eligibility Alport Syndrome NCT01705132

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion Criteria
Item
subjects eligible for inclusion in this study have to fulfill all of the following criteria:
boolean
C1512693 (UMLS CUI [1])
informed consent; compliance
Item
1. able to understand and comply with the requirements of the study and able to provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
gender; age
Item
2. male and female subjects ≥ 5 years of age.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
morning urine sample
Item
3. physically able to provide a single first-morning urine sample of at least 30 ml (one ounce).
boolean
C0439057 (UMLS CUI [1])
alport syndrome; genotyping
Item
4. alport syndrome diagnosis: clinical and/or histopathologic and/or genetic diagnosis of alport syndrome, as per the subject's physician and/or genotyping.
boolean
C1567741 (UMLS CUI [1])
C1285573 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria
Item
subjects fulfilling any of the following criteria are not eligible for inclusion in this study:
boolean
C0680251 (UMLS CUI [1])
investigational drugs
Item
1. use of investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
boolean
C0013227 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
chronic kidney disease; erythropoietin therapy
Item
2. chronic kidney disease, defined as a known diagnosis of ckd, and/or receiving chronic phosphate-lowering therapy or erythropoietin therapy.
boolean
C1561643 (UMLS CUI [1])
C0199970 (UMLS CUI [2])
Hemodialysis; renal transplant
Item
3. ongoing chronic hemodialysis therapy and/or renal transplant recipient.
boolean
C0019004 (UMLS CUI [1])
C0022671 (UMLS CUI [2])
Nephrotic range proteinuria; spot urine protein-to-creatinine ratio
Item
4. nephrotic-range proteinuria: spot urine protein-to-creatinine ratio ≥ 3 on at least 2 of the last 3 clinical assessments.
boolean
C0445118 (UMLS CUI [1])
C0457208 (UMLS CUI [2,1])
C1096054 (UMLS CUI [2,2])
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