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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01234363 |
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Date of registration:
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26/07/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Renal Allograft : Evaluation of Parenchymal Fibrosis by Elastography
GREFE |
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Scientific title:
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Evaluation of the Potential of Elastography for Noninvasive Assessment of Fibrosis in Kidney Transplant |
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Date of first enrolment:
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May 2010 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01234363 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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ROUVIERE Olivier, Pr |
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Address:
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Telephone:
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4 72 11 09 51 |
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Email:
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olivier.rouviere@netcourrier.com |
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Affiliation:
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Name:
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ROUVIERE Olivier, Pr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospices Civils de Lyon Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot, 69437 Lyon Cedex 03 |
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Name:
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ROUVIERE Olivier, Pr |
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Address:
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Telephone:
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472 11 09 51 |
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Email:
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olivier.rouviere@netcourrier.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Renal allograft performed less than 3 months before enrolment
Exclusion Criteria:
- Contra-indication to magnetic resonance imaging
- Contra-indication to biopsy
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Renal Transplant
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Intervention(s)
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Device: Magnetic Resonance Elastography, and Supersonic Shear Imaging
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Primary Outcome(s)
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Correlation between elasticity (as measured by elastography) and (a) Banff score for fibrosis, (b) glomerular filtration rate assessed by creatinine clearance, (c) glomerular filtration rate assessed by insulin clearance
[Time Frame: 3 months and 12 months after graft]
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Secondary Outcome(s)
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Tolerance (assessed by a questionnaire)
[Time Frame: 3 months and 12 months after graft]
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Number of technical failures
[Time Frame: 12 months]
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Correlation between elasticity and arterial resistance index
[Time Frame: 3 months and 12 months after graft]
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Evolution of the elasticity of the transplant between 3 and 12 months after graft
[Time Frame: 3 months and 12 months after graft]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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