Informações:
Falhas:
ID
14182
Descrição
Urinary Biomarkers of the Progression of Alport Kidney Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01705132
Link
https://clinicaltrials.gov/show/NCT01705132
Palavras-chave
Versões (1)
- 03/04/2016 03/04/2016 -
Transferido a
3 de abril de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Alport Syndrome NCT01705132
Eligibility Alport Syndrome NCT01705132
- StudyEvent: Eligibility
Similar models
Eligibility Alport Syndrome NCT01705132
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
C1285573 (UMLS CUI [2])
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])
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])
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])
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])
C0457208 (UMLS CUI [2,1])
C1096054 (UMLS CUI [2,2])