ID

14182

Description

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

Lien

https://clinicaltrials.gov/show/NCT01705132

Mots-clés

  1. 03/04/2016 03/04/2016 -
Téléchargé le

3 avril 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Alport Syndrome NCT01705132

Eligibility Alport Syndrome NCT01705132

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

Type de données

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

Type de données

boolean

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

gender; age

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

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

Hemodialysis; renal transplant

Type de données

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

Type de données

boolean

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

Similar models

Eligibility Alport Syndrome NCT01705132

Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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