Renal Allograft : Evaluation of Parenchymal Fibrosis by Elastography
GREFE
Evaluation of the Potential of Elastography for Noninvasive Assessment of Fibrosis in Kidney Transplant
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to assess the potential of elastography for noninvasive assessment of fibrosis in renal allograft.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 26, 2010
CompletedFirst Posted
Study publicly available on registry
November 4, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedSeptember 19, 2013
September 1, 2013
3.3 years
July 26, 2010
September 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
3 months and 12 months after graft
Secondary Outcomes (4)
Number of technical failures
12 months
Tolerance (assessed by a questionnaire)
3 months and 12 months after graft
Evolution of the elasticity of the transplant between 3 and 12 months after graft
3 months and 12 months after graft
Correlation between elasticity and arterial resistance index
3 months and 12 months after graft
Study Arms (1)
Magnetic Resonance Elastography, Supersonic Shear Imaging
EXPERIMENTALMagnetic Resonance Elastography and Supersonic Shear Imaging
Interventions
Magnetic Resonance Elastography, and Supersonic Shear Imaging
Eligibility Criteria
You may qualify if:
- Renal allograft performed less than 3 months before enrolment
You may not qualify if:
- Contra-indication to magnetic resonance imaging
- Contra-indication to biopsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot
Lyon, Lyon, 69437, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ROUVIERE Olivier, Pr
Hospices Civils de Lyon Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot, 69437 Lyon Cedex 03
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2010
First Posted
November 4, 2010
Study Start
May 1, 2010
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
September 19, 2013
Record last verified: 2013-09